Healthy Accents ibuprofen

Product NDC

55316-517

11-digit product format

553160517

Labeler code

55316

Product ID

55316-517_9637bfef-abaf-4445-9c62-7cfaf164c83e

Type

HUMAN OTC DRUG

Nonproprietary name

Ibuprofen

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

DZA Brands LLC

Application

ANDA077349

Marketing category

ANDA

Marketing start

2009-03-20

Marketing end

2019-06-30

Substance

IBUPROFEN

Active strength

200 mg/1

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record