Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC

70518-0919

11-digit product format

705180919

Labeler code

70518

Product ID

70518-0919_8f563a3d-6fef-0ca8-e053-2995a90aacc5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

diphenoxylate hydrochloride and atropine sulfate

Dosage form

TABLET

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA085762

Marketing category

ANDA

Marketing start

2017-12-21

Marketing end

0000-00-00

Substance

DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE

Active strength

3 mg/1; mg/1

Pharmacologic classes

Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

DEA schedule

CV

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record