Dicyclomine Hydrochloride

Product NDC
71610-209
11-digit product format
716100209
Labeler code
71610
Product ID
71610-209_dcd1f50a-a200-48b3-89f7-039081a9e72d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
71610-209-09716100209099000 TABLET in 1 BOTTLE (71610-209-09) 9000 tablet2018-12-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine HydrochlorideAphena Pharma Solutions - Tennessee, LLC2018-12-20HUMAN PRESCRIPTION DRUG LABEL1