Dicyclomine Hydrochloride

Product NDC
67296-1039
11-digit product format
672961039
Labeler code
67296
Product ID
67296-1039_d60f91b5-252e-145d-e053-2995a90af686
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040230
Marketing category
ANDA
Marketing start
1999-02-26
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1039-12026-01-29C16284748780-149896155-a111-586f-e063-e6dba90add90Dicyclomine 20 mg Tablet
67296-1039-72026-01-29C16284748780-149896155-a111-586f-e063-e6dba90add90Dicyclomine 20 mg Tablet
67296-1039-92026-01-29C16284748780-149896155-a111-586f-e063-e6dba90add90Dicyclomine 20 mg Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1039-1Dicyclomine Hydrochloride10 in 1 BOTTLETABLET107
67296-1039-7Dicyclomine Hydrochloride15 in 1 BOTTLETABLET157
67296-1039-9Dicyclomine Hydrochloride56 in 1 BOTTLETABLET567

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1039DICYCLOMINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]7Legacy NDC, 3 package rows20240712_4e2d33d8-84ad-2abd-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN4e2d33d8-84ad-2abd-e054-00144ff88e887
991086dicyclomine hydrochloride 20 MG Oral TabletSCD4e2d33d8-84ad-2abd-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1039-16729610390110 TABLET in 1 BOTTLE (67296-1039-1) 10 tablet1999-02-260000-00-00NoNoCurrent
67296-1039-76729610390715 in 1 BOTTLEHistorical
67296-1039-96729610390956 in 1 BOTTLEHistorical