Dicyclomine Hydrochloride

Product NDC
63187-410
11-digit product format
631870410
Labeler code
63187
Product ID
63187-410_33e2fa6e-66b0-436e-8a4d-235f3ba2c94d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040230
Marketing category
ANDA
Marketing start
1999-02-26
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
CQ903KQA31DICYCLOMINE HYDROCHLORIDE67-92-5DICYCLOMINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63187-410-156318704101515 TABLET in 1 BOTTLE (63187-410-15) 15 tablet2016-08-01NoNoHistorical
63187-410-306318704103030 TABLET in 1 BOTTLE (63187-410-30) 30 tablet2015-08-03NoNoHistorical
63187-410-606318704106060 TABLET in 1 BOTTLE (63187-410-60) 60 tablet2025-06-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine HydrochlorideProficient Rx LP2025-06-01HUMAN PRESCRIPTION DRUG LABEL7