Ibuprofen PM

Product NDC

36800-165

11-digit product format

368000165

Labeler code

36800

Product ID

36800-165_da90a140-5f31-4a43-866f-cad7ffcffdd6

Type

HUMAN OTC DRUG

Nonproprietary name

Ibuprofen and Diphenhydramine HCl

Dosage form

CAPSULE, LIQUID FILLED

Route

ORAL

Labeler

TOP CARE (Topco Associates LLC)

Application

ANDA090397

Marketing category

ANDA

Marketing start

2011-09-22

Marketing end

2019-12-31

Substance

IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE

Active strength

200 mg/1; mg/1

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record