Standard Pharmaceutical Product Information (Rx Product …

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: 40-663 I. Freezer between -25 and -10 C (-13 14 F). Rx Product /Proprietary Name: Warfarin Tablets, 1 mg, 100 ct II. Cold between 2 and 8 C (36 46 F). NDC: 68382-052-01 UPC: 368382052018 III. Cool between 8 and 15 C (46 59 F). CVX Code: MVX Code: x IV. Controlled Room between 20 and 25 C (68 77 F).

2 Description: Generic for Coumadin pink, oval, flat, beveled edge, uncoated tablets debossed with the logo of WAR', 1' and bisect on one allows for excursions between 15 and 30 C (59 86 F). side and plain on other side. V. Avoid Excessive Heat above 40 C (>104 F). Active ingredients: Warfarin VI. Other Temperature Range Requirement (write in). URL for Additional Product Information : VII. No Requirement Address: 73 Route 31 North Address 2: b. Contact for temperature excursion questions: City: Pennington State: NJ Zip: 08534 Name: Key Contact: Email: Number: Phone Number: (609) 730 1900 Fax: (609) 730 1991 Is this Product to be shipped to customers on ice?

3 No FOR GENERIC DRUG PRODUCTS Is this Product to be shipped to customers on dry ice? No I. Orange Book Rating: AB II. Brand Name: Coumadin III. Generic Equivalent for Brand: Warfarin Tablets, 1 mg, 100 ct c. Special regulations for Product in certain states? No DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) Information Special returns requirements for this Product ? No Does supplier meet DSCSA definition of manufacturer? Yes DUNS: 156861945. Is Product exempt from DSCSA? No d. Store Product (unit of sale) upright? Yes If yes, select exemption: Protect Product (unit of sale) from light? No Other exemption - Write in: Is Product repackaged? No If Yes, was original Product purchased direct from mfr?

4 E. Shelf life: 24 Months Is Product sold by manufacturer's exclusive distributor? No Initial shelf life at launch (if different): Months Are any waivers granted for Product ID/barcode? No If yes, attach documentation from FDA. ADDITIONAL Product Information ITEM AND PACKING Information . Is the Product Direct Ship Item ORDER Information Dimensions (US msmts.) Volume Weight Lbs. # Pieces: Legend Device? No Unit of Sale What is the NDC selling unit? Depth Height Width: (Cube). State Control? No x Bottle Each Item: G ARCOS reportable? No Box/Carton Co-Licensed? No Ampule (Write-in, 1 Box of 10 Vials) Box/. 0. Controlled Substance? No Glass Carton: Schedule Tube Minimum order quantity?

5 Yes Case: 24. (incl. N for non-narcotic) Vial Liquid Sgl Controlled Substance Code: Vial Liquid Multi If Yes, how many of which package type? Pallet: 144. Hazardous Material/Cytotoxic Agent? No Vial Powder Sql Each Vial Power Multi Inner/Carton/Pack Case: UPC: Is Other: Write In 1 Case Carton: If Unit Dose, is item bar coded to unit dose for hospital scanning? PHARMACY ORDER / BILL UNIT Other Product Information COST Information . Is it reverse numbered? Rec. sell unit to customer? Size/Strength/Form: Regular Cost Per Unit of Federal Excise Tax Per Invoice Cost (WAC) ($). 100ct/1mg/Tablets Sale ($) Unit of Sale WHOLESALER USE ONLY: (Write-in, 1 Vial) Product Shape: Oval Vendor #: Rx billing unit to pharmacy: Product Color: Pink $ Whsl.

6 Code #: x Each Fineline Code: Gram Product Imprint: WAR 1. Milliliter As of date: 9/10/2014. 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: Standard Pharmaceutical Product Information (Page 2). For Designated Drop Ship Only Products, Please Use Page 3. MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION. Is this Product (check all that apply): a. Cytotoxic? No b. CA Prop. 65 Carcinogen or Reproductive Toxicant? No Carcinogen Reproductive Toxicant Both Warning appears on label Hazardous Waste Identification c.

7 Contact Hazard? No EPA Hazardous Waste Code: d. Does this Product require special clean-up instructions? No (If yes, attach SDS with special instructions.). e. Does the Product contain DEHP? No Is this Product regulated for shipment by the DOT? No (if yes, answer a-d below and provide SDS). a. DOT Hazard Class Is this a reportable quantity? No b. UN/ID Number RQ Threshold: c. Packing Group Is this a marine pollutant? No 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?

8 GTIN-14. Small Quantity (49 CFR ) Serialized? Yes x Item x 2D Linear RFID 10368382052015. 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. Is the Product restricted for air shipment? If so, indicate restriction: REMS or registry RESTRICTIONS. Passenger Is there a REMS on this Product ? No Cargo If Yes, is it managed with a pharmacy registry ? Passenger & Cargo Website URL: ADD'L STORAGE Information Comments / Details: (For example, iPledge program?). Please check as appropriate for this Product .

9 Organic Inorganic Antineoplastic Steroid/Androgen Corrosive Oxidizer Aerosol Class; Identify NFPA Storage Level: RETURN INSTRUCTIONS. Contact tel. # if Product received damaged: 877-993-8779. Is Product returnable for credit: Listed Chemical (List I or II) (Indicate or Write-in below): URL/Link to returns policy: Ephedrine Special regulations or returns requirements for this Product in certain states? No Pseudoephedrine If so, which states? Other requirements? Comments? Phenylpropanolamine Iodine ( ). Other: CLASS OF TRADE RESTRICTION: ADDITIONAL Information . No restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices Yes If Unit Dose NDC, indicate NDC here: Restricted to retail pharmacy only: No MISCELLANEOUS NOTES and/or Image of Product Barcode: Restricted to hospital, clinics, and physician offices only: No Restricted from US territories?

10 (explain in comments) No Comments: Release DATE. Standard Pharmaceutical Product Information (Page 3). 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 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 No.: 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 Charges or Other Designated Drop Ship Fees: Overnight and Priority Overnight PO Processing Expedited freight fees billed with each order: Overnight receipt available: Drop Ship service fee billed with each order: PO Receipt cut off time: Drop Ship miscellaneous fees billed: Days of week overnight is available: Monday Comments.