Hydrocodone Bitartrate and Ibuprofen

Product NDC

63739-557

11-digit product format

637390557

Labeler code

63739

Product ID

63739-557_02304ee1-ad6b-47cc-9ade-5b7c61d4f5a7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Ibuprofen

Dosage form

TABLET

Route

ORAL

Labeler

McKesson Packaging Services a business unit of McKesson Corporation

Application

ANDA076642

Marketing category

ANDA

Marketing start

2012-05-21

Marketing end

0000-00-00

Substance

HYDROCODONE BITARTRATE; IBUPROFEN

Active strength

8 mg/1; mg/1

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

DEA schedule

CII

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record