Dicyclomine Hydrochloride

Product NDC
50090-7309
11-digit product format
500907309
Labeler code
50090
Product ID
50090-7309_bbfd15b7-d21a-461b-a4f2-3cfa965ff6b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA216782
Marketing category
ANDA
Marketing start
2023-07-01
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
50090-7309-05009073090030 TABLET in 1 BOTTLE (50090-7309-0) 30 tablet2024-10-14NoNoHistorical
50090-7309-25009073090220 TABLET in 1 BOTTLE (50090-7309-2) 20 tablet2024-10-14NoNoHistorical
50090-7309-85009073090890 TABLET in 1 BOTTLE (50090-7309-8) 90 tablet2024-10-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine HydrochlorideA-S Medication Solutions2025-12-31HUMAN PRESCRIPTION DRUG LABEL3