loperamide hydrochloride

Product NDC

0904-6256

11-digit product format

009046256

Labeler code

0904

Product ID

0904-6256_1df30a0d-eb4b-4a24-bfe6-7ad5d4c0e73c

Type

HUMAN OTC DRUG

Nonproprietary name

loperamide HCl

Dosage form

SUSPENSION

Route

ORAL

Labeler

Major Pharmaceuticals

Application

ANDA091292

Marketing category

ANDA

Marketing start

2012-03-14

Marketing end

0000-00-00

Substance

LOPERAMIDE HYDROCHLORIDE

Active strength

1 mg/7.5mL

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record