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FDA Product

Hydrocodone Bitartrate And Acetaminophen

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Hydrocodone Bitartrate And Acetaminophen

66336-748

Regulatory Information

66336-748

ANDA040155

C73584

October 11, 2011

USA

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

066070785

Active Ingredients

HYDROCODONE BITARTRATE

Quantity: 7.5 mg in 1 1

Code: NO70W886KK

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

STARCH, PREGELATINIZED CORN

Code: O8232NY3SJ

Class Code: IACT

ACETAMINOPHEN

Quantity: 650 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

Active Moieties

ACETAMINOPHEN

Code: 362O9ITL9D

HYDROCODONE

Code: 6YKS4Y3WQ7

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