Label: HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-804-27 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 13107-020
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CII
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 31, 2015
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- Description Section
- Clinical Pharmacology Section
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- Contraindications Section
- Warnings Section
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- Adverse Reactions Section
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- Overdosage Section
- How Supplied Section
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Package Label.Principal Display Panel
NDC: 51655-804-27
HYDROCODONE BIT & ACETAMINOPHEN 7.5MG/325MG CII
12 Tablets
Rx Only
Lot:
Exp:
Store at 20C to 25C (68-77F)
Keep out of reach of children.
Dosage: See package insert.
Manufactured By: Aurolife Pharma LLC
Manufacture Address: Dayton, NJ 08810
Manufacture NDC: 13107-020-05
Mfg Lot: 020150016B
Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256
Rx#:
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INGREDIENTS AND APPEARANCE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
hydrocodone bitartrate and acetaminophen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-804(NDC:13107-020) Route of Administration ORAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE 7.5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (White to Off-White) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code U02 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-804-27 12 in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201013 07/31/2015 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations EPM Packaging 079124340 repack(51655-804)