topcare loperamide hydrochloride

Product NDC

36800-645

11-digit product format

368000645

Labeler code

36800

Product ID

36800-645_c8a37884-9b52-46be-a0e5-f62c8d51a453

Type

HUMAN OTC DRUG

Nonproprietary name

loperamide HCl

Dosage form

SUSPENSION

Route

ORAL

Labeler

Topco Associates LLC

Application

ANDA091292

Marketing category

ANDA

Marketing start

2012-06-05

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