Dicyclomine Hydrochloride

Product NDC
71610-265
11-digit product format
716100265
Labeler code
71610
Product ID
71610-265_c5c78781-b840-4c6b-ad40-968ab2ae25ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
71610-265-09716100265099000 CAPSULE in 1 BOTTLE (71610-265-09) 9000 capsule2019-04-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine HydrochlorideAphena Pharma Solutions - Tennessee, LLC2019-04-29HUMAN PRESCRIPTION DRUG LABEL1