HYDROCODONE BITARTRATE AND IBUPROFEN

Product NDC

71335-0094

11-digit product format

713350094

Labeler code

71335

Product ID

71335-0094_e87aacac-be91-40c2-9c41-0f6c99ce8850

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

HYDROCODONE BITARTRATE AND IBUPROFEN

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

ANDA076604

Marketing category

ANDA

Marketing start

2004-04-01

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