Standard Pharmaceutical Product Information (Rx Product Only)

Transcription

1 Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Introduction Type: New Item Final Version Date: 8/25/2014 PRODUCT INFORMATION SPECIAL HANDLING AND STORAGE REQUIREMENTS* Company Name: Zydus Pharmaceuticals USA Inc. Application: ANDA a. Temperature Indicate the USP temperature range for this product. Application Number for NDA/ANDA/BLA, Med Device: I. Freezer between -25 and -10 C ( F) Rx Product/Proprietary Name: Tramadol Hydrochloride & Acetaminophen Tablets, USP 37.5mg/325mg, 100ct II. Cold between 2 and 8 C (36 46 F) NDC: UPC: III. Cool between 8 and 15 C (46 59 F) CVX Code: Description: MVX Code: White-color, capsule-shaped, bevel, biconvex, film-coated tablet, debossing '334' on one side and plain on the other side. x IV. Controlled Room between 20 and 25 C (68 77 F) allows for excursions between 15 and 30 C (59 86 F) V. Avoid Excessive Heat above 40 C (>104 F) Active ingredients: Tramadol & Acetaminophen VI. Other Temperature Range Requirement (write in) URL for Additional Product Information: VII. Requirement Address: 73 Route 31 rth Address 2: b. Contact for temperature excursion questions: City: Pennington State: NJ Zip: Name: Key Contact: Number: Phone Number: (609) Fax: (609) Is this product to be shipped to customers on ice? FOR GENERIC DRUG PRODUCTS Is this product to be shipped to customers on dry ice? I. Orange Book Rating: AB II. Brand Name: Ultracet III. Generic Equivalent for Brand: Tramadol Hydrochloride & Acetaminophen Tablets, USP 37.5mg/325mg, 100ct c. Special regulations for product in certain states? DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATION Special returns requirements for this product? Does supplier meet DSCSA definition of manufacturer? Yes DUNS: Is product exempt from DSCSA? d. Store product (unit of sale) upright? Yes If yes, select exemption: Protect product (unit of sale) from light? Other exemption - Write in: Is product repackaged? If Yes, was original product purchased direct from mfr? e. Shelf life: 24 Months Is product sold by manufacturer's exclusive distributor? Initial shelf life at launch (if different): Months Are any waivers granted for product ID/barcode? If yes, attach documentation from FDA ADDITIONAL PRODUCT INFORMATION ITEM AND PACKING INFORMATION Is the Product Direct Ship Item ORDER INFORMATION Dimensions (US msmts.) Weight Lbs. Legend Device? Unit of Sale What is the NDC selling unit? Depth Height Width: State Control? Yes x Bottle Each ARCOS reportable? Yes Box/Carton Item: G Co-Licensed? Ampule (Write-in, e.g. 1 Box of 10 Vials) Box/ Controlled Substance? Yes Glass Carton: Schedule.? IV Tube Minimum order quantity? Yes (incl. N for non-narcotic) Vial Liquid Sgl Controlled Substance Code: Vial Liquid Multi If Yes, how many of which package type? Hazardous Material/Cytotoxic Agent? Vial Powder Sql Each Case: Pallet: 5.00LBS Vial Power Multi Inner/Carton/Pack Case: UPC: Is Item... Other: Write In 1 Case Carton: If Unit Dose, is item bar coded to unit dose for hospital scanning? Is it reverse numbered? PHARMACY ORDER / BILL UNIT Rec. sell unit to customer? Other Product Information Size/Strength/Form: 100ct/37.5/325mg/Tablets WHOLESALER USE ONLY: (Write-in, e.g. 1 Vial) Product Shape: Capsule Vendor #: Rx billing unit to pharmacy: Product Color: White $60.00 Whsl. Code #: x Each Fineline Code: Gram Product Imprint: 334 Milliliter As of date: 9/10/2014 *Please provide any additional information on page 2. See new p. 3 for Designated Drop Ship Only. Signature: Regular Cost Per Unit of Sale ($) Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE. COST INFORMATION Invoice Cost (WAC) ($) Volume (Cube) # Pieces: Federal Excise Tax Per Unit of Sale

2 Standard Pharmaceutical Product Information (Page 2) Is this product (check all that apply): a. Cytotoxic? b. CA Prop. 65 Carcinogen or Reproductive Toxicant? Carcinogen Reproductive Toxicant Both Warning appears on label c. Contact Hazard? d. Does this product require special clean-up instructions? (If yes, attach SDS with special instructions.) e. Does the product contain DEHP? For Designated Drop Ship Only Products, Please Use Page 3 MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION Hazardous Waste Identification EPA Hazardous Waste Code: Is this product regulated for shipment by the DOT? (if yes, answer a-d below and provide SDS) a. DOT Hazard Class Is this a reportable quantity? b. UN/ID Number RQ Threshold: c. Packing Group Is this a marine pollutant? d. Inhalation Hazard? Is this product shipped utilizing an authorized DOT exception or Special Permit? (if yes, identify method below) Limited Quantity ADDITIONAL PRODUCT INFORMATION - Serialization Consumer Commodity, ORM-D Level How? Small Quantity (49 CFR 173.4) Serialized? Yes x Item x 2D Linear RFID Special Permit; DOT-SP If not, when? x Box/Carton x 2D Linear RFID Special Provision (listed in Column 7 of 49 CFR ); Items aggregated to case? x Case x 2D Linear RFID SP# x Pallet x 2D Linear RFID GTIN Is the product restricted for air shipment? If so, indicate restriction: Passenger Is there a REMS on this product? Cargo If Yes, is it managed with a pharmacy registry? Passenger & Cargo Website URL: Please check as appropriate for this product. Organic Inorganic Antineoplastic Steroid/Androgen Corrosive Oxidizer Comments / Details: (For example, ipledge program?) Aerosol Class; Identify NFPA Storage Level: RETURN INSTRUCTIONS Contact tel. # if product received damaged: Is product returnable for credit: Listed Chemical (List I or II) (Indicate or Write-in below): URL/Link to returns policy: Ephedrine Pseudoephedrine Phenylpropanolamine Iodine ( 2.2%) Other: restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices Yes If Unit Dose NDC, indicate NDC here: Restricted to hospital, clinics, and physician offices only: Restricted from US territories? (explain in comments) ADD'L STORAGE INFORMATION CLASS OF TRADE RESTRICTION: REMS or REGISTRY RESTRICTIONS 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 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: REMS: Contact # if product is received damaged: REMS Program Manager Name: Phone: Is product returnable for credit: Supplier Manages REMS registry exclusively: URL/Link to returns policy: Wholesale distributor support: Provider Name: Site Enrollment Number assigned by Supplier: DEA #: PCPDP #: NPI #: Registry: Registry Program Contact Name: Phone: Is product order for scheduled patient procedure? Comments Is product order for restocking purposes? 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: REMS or Registry Restrictions Other Data Information Required to Process PO: Priority Overnight receipt available: Overnight and Priority Overnight PO Processing Return Instructions Miscellaneous tes:

4 Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Introduction Type: New Item Final Version Date: 8/25/2014 PRODUCT INFORMATION SPECIAL HANDLING AND STORAGE REQUIREMENTS* Company Name: Zydus Pharmaceuticals USA Inc. Application: ANDA a. Temperature Indicate the USP temperature range for this product. Application Number for NDA/ANDA/BLA, Med Device: I. Freezer between -25 and -10 C ( F) Rx Product/Proprietary Name: Tramadol Hydrochloride & Acetaminophen Tablets, USP 37.5mg/325mg, 500ct II. Cold between 2 and 8 C (36 46 F) NDC: UPC: III. Cool between 8 and 15 C (46 59 F) CVX Code: Description: MVX Code: White-color, capsule-shaped, bevel, biconvex, film-coated tablet, debossing '334' on one side and plain on the other side. x IV. Controlled Room between 20 and 25 C (68 77 F) allows for excursions between 15 and 30 C (59 86 F) V. Avoid Excessive Heat above 40 C (>104 F) Active ingredients: Tramadol & Acetaminophen VI. Other Temperature Range Requirement (write in) URL for Additional Product Information: VII. Requirement Address: 73 Route 31 rth Address 2: b. Contact for temperature excursion questions: City: Pennington State: NJ Zip: Name: Key Contact: Number: Phone Number: (609) Fax: (609) Is this product to be shipped to customers on ice? FOR GENERIC DRUG PRODUCTS Is this product to be shipped to customers on dry ice? I. Orange Book Rating: AB II. Brand Name: Ultracet III. Generic Equivalent for Brand: Tramadol Hydrochloride & Acetaminophen Tablets, USP 37.5mg/325mg, 500ct c. Special regulations for product in certain states? DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATION Special returns requirements for this product? Does supplier meet DSCSA definition of manufacturer? Yes DUNS: Is product exempt from DSCSA? d. Store product (unit of sale) upright? Yes If yes, select exemption: Protect product (unit of sale) from light? Other exemption - Write in: Is product repackaged? If Yes, was original product purchased direct from mfr? e. Shelf life: 24 Months Is product sold by manufacturer's exclusive distributor? Initial shelf life at launch (if different): Months Are any waivers granted for product ID/barcode? If yes, attach documentation from FDA ADDITIONAL PRODUCT INFORMATION ITEM AND PACKING INFORMATION Is the Product Direct Ship Item ORDER INFORMATION Dimensions (US msmts.) Weight Lbs. Legend Device? Unit of Sale What is the NDC selling unit? Depth Height Width: State Control? x Bottle Each ARCOS reportable? Box/Carton Item: G Co-Licensed? Ampule (Write-in, e.g. 1 Box of 10 Vials) Box/ Controlled Substance? Glass Carton: Schedule.? Controlled Substance Code: Tube Minimum order quantity? Vial Liquid Multi Yes If Yes, how many of which package type? (incl. N for non-narcotic) Hazardous Material/Cytotoxic Agent? Vial Liquid Sgl Vial Powder Sql Each Case: Pallet: 8.70LBS Vial Power Multi Inner/Carton/Pack Case: UPC: Is Item... Other: Write In 1 Case Carton: If Unit Dose, is item bar coded to unit dose for hospital scanning? Is it reverse numbered? PHARMACY ORDER / BILL UNIT Rec. sell unit to customer? Other Product Information Size/Strength/Form: 500ct/37.5/325mg/Tablets WHOLESALER USE ONLY: (Write-in, e.g. 1 Vial) Product Shape: Capsuled Vendor #: Rx billing unit to pharmacy: Product Color: White $ Whsl. Code #: x Each Fineline Code: Gram Product Imprint: 334 Milliliter As of date: 9/10/2014 *Please provide any additional information on page 2. See new p. 3 for Designated Drop Ship Only. Signature: Regular Cost Per Unit of Sale ($) Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE. COST INFORMATION Invoice Cost (WAC) ($) Volume (Cube) # Pieces: Federal Excise Tax Per Unit of Sale

5 Standard Pharmaceutical Product Information (Page 2) Is this product (check all that apply): a. Cytotoxic? b. CA Prop. 65 Carcinogen or Reproductive Toxicant? Carcinogen Reproductive Toxicant Both Warning appears on label c. Contact Hazard? d. Does this product require special clean-up instructions? (If yes, attach SDS with special instructions.) e. Does the product contain DEHP? For Designated Drop Ship Only Products, Please Use Page 3 MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION Hazardous Waste Identification EPA Hazardous Waste Code: Is this product regulated for shipment by the DOT? (if yes, answer a-d below and provide SDS) a. DOT Hazard Class Is this a reportable quantity? b. UN/ID Number RQ Threshold: c. Packing Group Is this a marine pollutant? d. Inhalation Hazard? Is this product shipped utilizing an authorized DOT exception or Special Permit? (if yes, identify method below) Limited Quantity ADDITIONAL PRODUCT INFORMATION - Serialization Consumer Commodity, ORM-D Level How? Small Quantity (49 CFR 173.4) Serialized? Yes x Item x 2D Linear RFID Special Permit; DOT-SP If not, when? x Box/Carton x 2D Linear RFID Special Provision (listed in Column 7 of 49 CFR ); Items aggregated to case? x Case x 2D Linear RFID SP# x Pallet x 2D Linear RFID GTIN Is the product restricted for air shipment? If so, indicate restriction: Passenger Is there a REMS on this product? Cargo If Yes, is it managed with a pharmacy registry? Passenger & Cargo Website URL: Please check as appropriate for this product. Organic Inorganic Antineoplastic Steroid/Androgen Corrosive Oxidizer Comments / Details: (For example, ipledge program?) Aerosol Class; Identify NFPA Storage Level: RETURN INSTRUCTIONS Contact tel. # if product received damaged: Is product returnable for credit: Listed Chemical (List I or II) (Indicate or Write-in below): URL/Link to returns policy: Ephedrine Pseudoephedrine Phenylpropanolamine Iodine ( 2.2%) Other: restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices Yes If Unit Dose NDC, indicate NDC here: Restricted to hospital, clinics, and physician offices only: Restricted from US territories? (explain in comments) ADD'L STORAGE INFORMATION CLASS OF TRADE RESTRICTION: REMS or REGISTRY RESTRICTIONS 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 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: REMS: Contact # if product is received damaged: REMS Program Manager Name: Phone: Is product returnable for credit: Supplier Manages REMS registry exclusively: URL/Link to returns policy: Wholesale distributor support: Provider Name: Site Enrollment Number assigned by Supplier: DEA #: PCPDP #: NPI #: Registry: Registry Program Contact Name: Phone: Is product order for scheduled patient procedure? Comments Is product order for restocking purposes? 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: REMS or Registry Restrictions Other Data Information Required to Process PO: Priority Overnight receipt available: Overnight and Priority Overnight PO Processing Return Instructions Miscellaneous tes: