Hydrocodone bitartrate and ibuprofen

Product NDC

57664-281

11-digit product format

576640281

Labeler code

57664

Product ID

57664-281_5fc8dccb-c6eb-0b9a-e053-2a91aa0a7bad

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone bitartrate and ibuprofen

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Sun Pharmaceutical Industries, Inc.

Application

ANDA091633

Marketing category

ANDA

Marketing start

2013-05-28

Marketing end

0000-00-00

Substance

HYDROCODONE BITARTRATE; IBUPROFEN

Active strength

3 mg/1; mg/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Opioid Agonist [EPC],Opioid Agonists [MoA]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record