Standard Pharmaceutical Product Information (Rx Product Only)

Transcription

1 Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Introduction Type: Post Launch Change Final Version Date: Company Name: ZYDUS PHARMACEUTICALS (USA) INC. Application Number for NDA/ANDA/BLA (drug); PMA/510(k)(med device): a. Temperature Indicate the USP temperature range for this product. Temperature Range Controlled Room between 20 and 25 C (68 77 DUNS: Other Temperature Range Requirement Proprietary Name (If Applicable) and Established Name: Gabapentin Tablets, 600 mg, 100 ct (write in) Selling Unit NDC: Individual Unit NDC: UPC: UDI CVX Code: MVX Code: Is this product to be shipped to customers on ice? Description: Is this product to be shipped to customers on dry ice? Active Ingredient(s): Gabapentin b. Contact for temperature excursion questions: Name: URL for Additional Product Information: Number: Address: 73 ROUTE 31 NORTH Address 2: Group City: PENNINGTON State: NJ Zip: Key Contact: c. Special regulations for product in any states? Phone Number: (609) Fax: (609) Special returns requirements for this product? Product Therapeutic Classification: White to off-white, oval-shaped, biconvex, film-coated tablets, debossed with 'ZE72' with bisect on one side and plain with bisect on the other side. ADDITIONAL PRODUCT INFORMATION PRODUCT INFORMATION PRODUCT DESCRIPTION INFORMATION d. Store product (unit of sale) upright? Yes Protect product (unit of sale) from light? e. Shelf life: 24 Months a legend device? Initial shelf life at launch (if different): Months Size: 100 COUNT reverse numbered? co-licensed? ORDER INFORMATION Strength: 600 MG Direct-Ship Only Neither Unit of Sale What is the NDC selling unit? Dosage Form: TABLETS X Bottle I BOTTLE OF 100 TABLETS Box/Carton (Write-in, e.g. 1 Box of 10 Vials) If Unit Dose, is item bar coded to unit dose for hospital scanning? Ampule Product Shape: OVAL If Unit Dose NDC, indicate NDC here: Glass Minimum order quantity? Yes Tube Product Color: WHITE TO OFF WHITE Country of Origin Vial Liquid Sgl Is this product covered under the Trade Agreements Act (TAA)? Product Imprint: ZE 72 Vial Liquid Multi If Yes, how many of which package type? Vial Powder Sql Each Vial Power Multi Inner/Carton/Pack Other: Write In 1 Case FOR GENERIC DRUG PRODUCTS Authorized Generic *If Authorized Generic, other section PHARMACY ORDER / BILL UNIT I. Orange Book Rating: AB fields are not applicable Rec. sell unit to customer? Rx billing unit to pharmacy: II. Generic Equivalent to What Brand?: Neurontin X Each (Write-in, e.g. 1 Vial) Gram DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATION Milliliter Does supplier meet DSCSA definition of manufacturer? Yes GLN: ITEM AND PACKING INFORMATION Is product exempt from DSCSA? If yes, select exemption: Dimensions (US msmts.) Volume Weight Lbs. Other exemption - Write in: Depth Height Width (Cube) # Pieces: Is product repackaged? If Yes, was original product purchased direct Item: Is product sold by manufacturer's exclusive distributor? from mfr? GTIN PRODUCT INFORMATION Saleable Has FDA granted waiver/exception/exemption for product? If yes, attach documentation from FDA. Box/Carton/Bundle/ Inner Pack: G 8.22 LBS Level Unit Quantity GTIN-14 Pallet: Serialized? X Item X X If not, when? 1/1/2018 Box/Carton/Bundle/Inner Pack UPC: Items aggregated? Yes X Case X Carton: X Pallet X COST INFORMATION WHOLESALER USE ONLY: Application: ANDA SPECIAL HANDLING AND STORAGE REQUIREMENTS* Regular Cost Vendor #: Invoice Cost (WAC) ($) $14.74 Whsl. Code #: Federal Excise Tax Per Unit of Sale Fineline Code: As of date: 8/10/2018 7/10/2017 Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE. *Please provide any additional information on page 2. See new p. 3 for Designated Drop Ship Only. Signature:

2 Standard Pharmaceutical Product Information (Page 2) Is this product (check all that apply): a. Cytotoxic? SDS Hazard Classification b. CA Prop. 65 Carcinogen or Reproductive Toxicant? Is the product a CA Prop 65 carcinogen? Organic Corrosive Is the product a CA Prop 65 reproductive toxicant? Inorganic Oxidizer Does the product label bear a CA Prop 65 warning? Steroid/Androgen Contact Hazard c. Contact Hazard? Aerosol Class; Identify NFPA Storage Level: d. Does this product require special clean-up instructions? (If yes, attach SDS with special instructions.) Is the product a NIOSH hazardous drug? e. Does the product contain DEHP? If yes, indicate which: Is this product regulated for shipment by DOT or IATA? (if yes, answer a-e below and provide SDS) a. UN/Identification Number b. Proper Shipping Name c. DOT Hazard Class EPA Hazardous Waste Code: d. Packing Group e. Inhalation Hazard? Is the product restricted for air shipment? If so, indicate restriction: Passenger Cargo Passenger & Cargo REMS or REGISTRY RESTRICTIONS Is there a REMS on this product? If Yes, is it managed with a pharmacy registry? Website URL: Is this a reportable quantity? RQ Threshold: / Details: (For example, ipledge program?) Is this a marine pollutant? Is this product shipped utilizing an authorized DOT exception or Special Permit? (if yes, identify method below) REMS: Limited Quantity REMS Program Manager Name: Phone: Consumer Commodity, ORM-D Supplier Manages REMS registry exclusively: Small Quantity (49 CFR 173.4) Wholesale distributor support: Special Permit; DOT-SP Provider Name: Special Provision (listed in Column 7 of 49 CFR ); Site Enrollment Number assigned DEA #: SP# by Supplier: PCPDP #: NPI #: ADD'L STORAGE INFORMATION Controlled Substance? Controlled by State(s)? Registry: ARCOS Reportable? Registry Program Contact Name: Phone: Schedule. (inc. N for non-narcotic) Controlled Substance Code Listed Chemical (List I or II) RETURN INSTRUCTIONS If yes, indicate which: Is it a scheduled listed chemical product?: Contact tel. # if product received damaged: (877) restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices URL/Link to returns policy: Restricted to retail pharmacy only: Special regulations or returns requirements for this product in certain states? Restricted to hospital, clinics, and physician offices only: If so, which states? Other requirements?? Restricted from US territories? (explain in comments) CLASS OF TRADE RESTRICTION: For Designated Drop Ship Only Products, Please Use Page 3 MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION Hazardous Waste Identification MISCELLANEOUS NOTES and/or Image of Product Barcode: Release DATE

3 Standard Pharmaceutical Product Information (Page 3) Purchase orders may be accepted by: Purchase order daily receipt cut off time by supplier a. EDI Cut off time: b. Autofax Fax Number: c. Fax Fax Number: Shipping lead time of PO: Hours Days d. Phone only Phone.: e. Supplier Web Site only Site Address: Ships same day for next day receipt: Minimum Order Quantity: Ships for second day receipt: Supplier's Customer Service Number: Ships regular ground for 3-10 days receipt: Contracted 3PL company / contact #: Name: Phone: Expedited freight fees billed with each order: Drop Ship service fee billed with each order: Overnight receipt available: PO Receipt cut off time: Drop Ship miscellaneous fees billed: Days of week overnight is available: Monday Tuesday Wednesday Thursday Friday restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices Saturday Overnight receipt available: Restricted to retail pharmacy only: Restricted to hospital, clinics, and physician offices only: Phone: Phone #: Order receipt method: Restricted from US territories? (explain in comments) Fax: Fax #: EDI: Overnight Fees apply: Other fees apply: Patient Procedure Date: Physician Name: Physician/Clinic Phone # Physician State License # Physician/Clinic DEA #: Physician/Clinic Specialty: FOR DESIGNATED DROP SHIP PRODUCT ONLY - if not a designated drop ship, do not complete. Order Method for Designated Drop Ship Product Standard Order Receipt and Processing Expedited Freight Charges or Other Designated Drop Ship Fees: Class of Trade Restriction: Other Data Information Required to Process PO: Miscellaneous tes: Priority Overnight receipt available: Overnight and Priority Overnight PO Processing Return Instructions Contact # if product is received damaged: URL/Link to returns policy: Special regulations or returns requirements for this product in certain states? If so, which states? Other requirements?? ADDITIONAL INFORMATION Is product order for scheduled patient procedure? Is product order for restocking purposes?

4 Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Introduction Type: Post Launch Change Final Version Date: Company Name: ZYDUS PHARMACEUTICALS (USA) INC. Application Number for NDA/ANDA/BLA (drug); PMA/510(k)(med device): a. Temperature Indicate the USP temperature range for this product. Temperature Range Controlled Room between 20 and 25 C (68 77 DUNS: Other Temperature Range Requirement Proprietary Name (If Applicable) and Established Name: Gabapentin Tablets, 600 mg, 500 ct (write in) Selling Unit NDC: Individual Unit NDC: UPC: UDI CVX Code: MVX Code: Is this product to be shipped to customers on ice? Description: Is this product to be shipped to customers on dry ice? Active Ingredient(s): Gabapentin b. Contact for temperature excursion questions: Name: URL for Additional Product Information: Number: Address: 73 ROUTE 31 NORTH Address 2: Group City: PENNINGTON State: NJ Zip: Key Contact: c. Special regulations for product in any states? Phone Number: (609) Fax: (609) Special returns requirements for this product? Product Therapeutic Classification: PRODUCT INFORMATION d. Store product (unit of sale) upright? Yes Protect product (unit of sale) from light? e. Shelf life: 24 Months a legend device? Initial shelf life at launch (if different): Months Size: 500 COUNT reverse numbered? co-licensed? ORDER INFORMATION Strength: 600 MG Direct-Ship Only Neither Unit of Sale What is the NDC selling unit? Dosage Form: TABLETS X Bottle 1 BOTTLE OF 500 TABLETS Box/Carton (Write-in, e.g. 1 Box of 10 Vials) If Unit Dose, is item bar coded to unit dose for hospital scanning? Ampule Product Shape: OVAL If Unit Dose NDC, indicate NDC here: Glass Minimum order quantity? Yes Tube Product Color: WHITE TO OFF WHITE Country of Origin Vial Liquid Sgl Is this product covered under the Trade Agreements Act (TAA)? Product Imprint: ZE 72 Vial Liquid Multi If Yes, how many of which package type? Vial Powder Sql Each Vial Power Multi Inner/Carton/Pack Other: Write In 1 Case FOR GENERIC DRUG PRODUCTS Authorized Generic *If Authorized Generic, other section PHARMACY ORDER / BILL UNIT I. Orange Book Rating: AB fields are not applicable Rec. sell unit to customer? Rx billing unit to pharmacy: II. Generic Equivalent to What Brand?: Neurontin X Each (Write-in, e.g. 1 Vial) Gram DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATION Milliliter Does supplier meet DSCSA definition of manufacturer? Yes GLN: ITEM AND PACKING INFORMATION Is product exempt from DSCSA? If yes, select exemption: Dimensions (US msmts.) Volume Weight Lbs. Other exemption - Write in: Depth Height Width (Cube) # Pieces: Is product repackaged? If Yes, was original product purchased direct Item: Is product sold by manufacturer's exclusive distributor? from mfr? GTIN PRODUCT INFORMATION Saleable Has FDA granted waiver/exception/exemption for product? If yes, attach documentation from FDA. Box/Carton/Bundle/ Inner Pack: G LBS Level Unit Quantity GTIN-14 Pallet: Serialized? X Item X X If not, when? 1/1/2018 Box/Carton/Bundle/Inner Pack UPC: Items aggregated? Yes X Case X Carton: X Pallet X COST INFORMATION WHOLESALER USE ONLY: Application: White to off-white, oval-shaped, biconvex, film-coated tablets, debossed with 'ZE72' with bisect on one side and plain with bisect on the other side. ADDITIONAL PRODUCT INFORMATION PRODUCT DESCRIPTION INFORMATION ANDA SPECIAL HANDLING AND STORAGE REQUIREMENTS* Regular Cost Vendor #: Invoice Cost (WAC) ($) $70.02 Whsl. Code #: Federal Excise Tax Per Unit of Sale Fineline Code: As of date: 8/10/2018 7/10/2017 Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE. *Please provide any additional information on page 2. See new p. 3 for Designated Drop Ship Only. Signature:

5 Standard Pharmaceutical Product Information (Page 2) Is this product (check all that apply): a. Cytotoxic? SDS Hazard Classification b. CA Prop. 65 Carcinogen or Reproductive Toxicant? Is the product a CA Prop 65 carcinogen? Organic Corrosive Is the product a CA Prop 65 reproductive toxicant? Inorganic Oxidizer Does the product label bear a CA Prop 65 warning? Steroid/Androgen Contact Hazard c. Contact Hazard? Aerosol Class; Identify NFPA Storage Level: d. Does this product require special clean-up instructions? (If yes, attach SDS with special instructions.) Is the product a NIOSH hazardous drug? e. Does the product contain DEHP? If yes, indicate which: Is this product regulated for shipment by DOT or IATA? (if yes, answer a-e below and provide SDS) a. UN/Identification Number b. Proper Shipping Name c. DOT Hazard Class EPA Hazardous Waste Code: d. Packing Group e. Inhalation Hazard? Is the product restricted for air shipment? If so, indicate restriction: Passenger Cargo Passenger & Cargo REMS or REGISTRY RESTRICTIONS Is there a REMS on this product? If Yes, is it managed with a pharmacy registry? Website URL: Is this a reportable quantity? RQ Threshold: / Details: (For example, ipledge program?) Is this a marine pollutant? Is this product shipped utilizing an authorized DOT exception or Special Permit? (if yes, identify method below) REMS: Limited Quantity REMS Program Manager Name: Phone: Consumer Commodity, ORM-D Supplier Manages REMS registry exclusively: Small Quantity (49 CFR 173.4) Wholesale distributor support: Special Permit; DOT-SP Provider Name: Special Provision (listed in Column 7 of 49 CFR ); Site Enrollment Number assigned DEA #: SP# by Supplier: PCPDP #: NPI #: ADD'L STORAGE INFORMATION Controlled Substance? Controlled by State(s)? Registry: ARCOS Reportable? Registry Program Contact Name: Phone: Schedule. (inc. N for non-narcotic) Controlled Substance Code Listed Chemical (List I or II) RETURN INSTRUCTIONS If yes, indicate which: Is it a scheduled listed chemical product?: Contact tel. # if product received damaged: (877) restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices URL/Link to returns policy: Restricted to retail pharmacy only: Special regulations or returns requirements for this product in certain states? Restricted to hospital, clinics, and physician offices only: If so, which states? Other requirements?? Restricted from US territories? (explain in comments) CLASS OF TRADE RESTRICTION: For Designated Drop Ship Only Products, Please Use Page 3 MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION Hazardous Waste Identification MISCELLANEOUS NOTES and/or Image of Product Barcode: Release DATE

6 Standard Pharmaceutical Product Information (Page 3) Purchase orders may be accepted by: Purchase order daily receipt cut off time by supplier a. EDI Cut off time: b. Autofax Fax Number: c. Fax Fax Number: Shipping lead time of PO: Hours Days d. Phone only Phone.: e. Supplier Web Site only Site Address: Ships same day for next day receipt: Minimum Order Quantity: Ships for second day receipt: Supplier's Customer Service Number: Ships regular ground for 3-10 days receipt: Contracted 3PL company / contact #: Name: Phone: Expedited freight fees billed with each order: Drop Ship service fee billed with each order: Overnight receipt available: PO Receipt cut off time: Drop Ship miscellaneous fees billed: Days of week overnight is available: Monday Tuesday Wednesday Thursday Friday restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices Saturday Overnight receipt available: Restricted to retail pharmacy only: Restricted to hospital, clinics, and physician offices only: Phone: Phone #: Order receipt method: Restricted from US territories? (explain in comments) Fax: Fax #: EDI: Overnight Fees apply: Other fees apply: Patient Procedure Date: Physician Name: Physician/Clinic Phone # Physician State License # Physician/Clinic DEA #: Physician/Clinic Specialty: FOR DESIGNATED DROP SHIP PRODUCT ONLY - if not a designated drop ship, do not complete. Order Method for Designated Drop Ship Product Standard Order Receipt and Processing Expedited Freight Charges or Other Designated Drop Ship Fees: Class of Trade Restriction: Other Data Information Required to Process PO: Miscellaneous tes: Priority Overnight receipt available: Overnight and Priority Overnight PO Processing Return Instructions Contact # if product is received damaged: URL/Link to returns policy: Special regulations or returns requirements for this product in certain states? If so, which states? Other requirements?? ADDITIONAL INFORMATION Is product order for scheduled patient procedure? Is product order for restocking purposes?