HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Hydrocodone Bitartrate and Acetaminophen by

Drug Labeling and Warnings

Hydrocodone Bitartrate and Acetaminophen by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals, EPM Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Boxed Warning Section

Description Section

Clinical Pharmacology Section

Indications and Usage Section

Contraindications Section

Warnings Section

Precautions Section

Adverse Reactions Section

Drug Abuse and Dependence Section

Overdosage Section

How Supplied Section

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#:

INGREDIENTS AND APPEARANCE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
hydrocodone bitartrate and acetaminophen tablet

Product 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)