IBUDONE

Product NDC

50991-579

11-digit product format

509910579

Labeler code

50991

Product ID

50991-579_7fafdef6-38b6-823a-e053-2991aa0a7fb4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydrocodone bitartrate and ibuprofen

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Poly Pharmaceuticals

Application

ANDA077723

Marketing category

ANDA

Marketing start

2006-11-06

Marketing end

2019-09-30

Substance

HYDROCODONE BITARTRATE; IBUPROFEN

Active strength

10 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

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record