Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC

0615-7801

11-digit product format

006157801

Labeler code

0615

Product ID

0615-7801_2e43a2b5-8ec9-4b4c-839f-9958899e33a0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

diphenoxylate hydrochloride and atropine sulfate

Dosage form

TABLET

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

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

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record