leader cough dm

Product NDC

49781-138

11-digit product format

497810138

Labeler code

49781

Product ID

49781-138_4e74ed46-1f10-4343-b063-cbedd3d1ca39

Type

HUMAN OTC DRUG

Nonproprietary name

dextromethorphan polistirex

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

Labeler

Cardinal Health

Application

ANDA091135

Marketing category

ANDA

Marketing start

2015-04-03

Marketing end

2019-05-01

Substance

DEXTROMETHORPHAN HYDROBROMIDE

Active strength

30 mg/5mL

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record