Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC

55700-255

11-digit product format

557000255

Labeler code

55700

Product ID

55700-255_88532dc0-a924-4cd1-9c97-172bb47782b1

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Diphenoxylate Hydrochloride and Atropine Sulfate

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

NDA012462

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2013-02-27

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