Dicyclomine Hydrochloride

Product NDC
58118-1282
11-digit product format
581181282
Labeler code
58118
Product ID
58118-1282_b01088a3-6611-05bf-e053-2995a90ad2ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA040230
Marketing category
ANDA
Marketing start
2019-03-06
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-1282-82024-01-30C16284748780-11030e365-051d-111a-e063-dadaa90a10e2128f8251-4f6d-4012-8087-f9fc4a484c92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-1282DICYCLOMINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]3Legacy NDC20200925_128f8251-4f6d-4012-8087-f9fc4a484c92.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-1282-85811812820830 TABLET in 1 BLISTER PACK (58118-1282-8) 30 tablet2019-03-060000-00-00NoNoCurrent