Dicyclomine

Product NDC
0615-8561
11-digit product format
006158561
Labeler code
0615
Product ID
0615-8561_c441cf93-8640-4a93-9be2-86c751358a31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA040161
Marketing category
ANDA
Marketing start
1996-10-01
Marketing end
2026-05-31
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8561-39Dicyclomine30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8561DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, 1 package rows20250223_a48a5b44-3812-4544-82d8-660763d76fd3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8561-390061585613930 TABLET in 1 BLISTER PACK (0615-8561-39) 30 tablet2025-02-132026-05-31NoNoHistorical