Boxed Warning Section

Description Section

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#:

51655-804-27

HYDROCODONE BITARTRATE AND ACETAMINOPHEN
hydrocodone bitartrate and acetaminophen tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)	HYDROCODONE BITARTRATE	7.5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51655-804-27	12 in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA201013	07/31/2015

Labeler - Northwind Pharmaceuticals (036986393)

Registrant - Northwind Pharmaceuticals (036986393)

Name	Address	ID/FEI	Business Operations
Establishment
EPM Packaging		079124340	repack(51655-804)