Dicyclomine Hydrochloride

Product NDC
68071-3606
11-digit product format
680713606
Labeler code
68071
Product ID
68071-3606_1b42169a-6601-b422-e063-6294a90abe76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040317
Marketing category
ANDA
Marketing start
2023-04-25
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
68071-3606-6680713606066 TABLET in 1 BOTTLE (68071-3606-6) 6 tablet2024-06-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine HydrochlorideNuCare Pharmaceuticals,Inc.2024-06-19HUMAN PRESCRIPTION DRUG LABEL1