Healthy Accents ibuprofen

Product NDC

55316-166

11-digit product format

553160166

Labeler code

55316

Product ID

55316-166_30e49d77-1bda-4ab5-b7f5-87d819426a64

Type

HUMAN OTC DRUG

Nonproprietary name

Ibuprofen

Dosage form

SUSPENSION

Route

ORAL

Labeler

DZA Brands LLC

Application

ANDA074937

Marketing category

ANDA

Marketing start

2008-03-03

Marketing end

0000-00-00

Substance

IBUPROFEN

Active strength

100 mg/5mL

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record