Dicyclomine Hydrochloride

Product NDC

53703-800

11-digit product format

537030800

Labeler code

53703

Product ID

53703-800_a81ed77a-1ea5-4399-a2a4-bf8a3c3240a7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dicyclomine Hydrochloride

Dosage form

SYRUP

Route

ORAL

Labeler

Entera Health, Inc.

Application

ANDA040169

Marketing category

ANDA

Marketing start

2015-04-27

Marketing end

0000-00-00

Substance

DICYCLOMINE HYDROCHLORIDE

Active strength

10 mg/mL

Pharmacologic classes

Anticholinergic [EPC],Cholinergic Antagonists [MoA]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record