Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC

68788-9135

11-digit product format

687889135

Labeler code

68788

Product ID

68788-9135_55ca0657-4083-4d17-b0cd-95d640a5d5e7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

diphenoxylate hydrochloride and atropine sulfate

Dosage form

TABLET

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA085762

Marketing category

ANDA

Marketing start

1977-11-17

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

2019-12-31

Current FDA listing

Historical FDA.report record