Dicyclomine Hydrochloride

Product NDC
63187-196
11-digit product format
631870196
Labeler code
63187
Product ID
63187-196_33e2fa6e-66b0-436e-8a4d-235f3ba2c94d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA084285
Marketing category
ANDA
Marketing start
1974-09-30
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 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
63187-196-306318701963030 CAPSULE in 1 BOTTLE (63187-196-30) 30 capsule2015-08-03NoNoHistorical
63187-196-906318701969090 CAPSULE in 1 BOTTLE (63187-196-90) 90 capsule2015-08-03NoNoHistorical

Related DailyMed Labels

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