Hydrocodone Bitartrate and Ibuprofen

Product NDC

49999-588

11-digit product format

499990588

Labeler code

49999

Product ID

49999-588_9309c8e8-2168-4fc1-a12f-01fb41fb4d67

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Ibuprofen

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA076604

Marketing category

ANDA

Marketing start

2010-11-17

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]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record