FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
71335-0641
11-digit product format
713350641
Labeler code
71335
Product ID
71335-0641_b90756d4-db4b-496b-9ad1-12978bdc3d3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA085223
Marketing category
ANDA
Marketing start
1986-07-30
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
71335-0641-12024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
71335-0641-22024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
71335-0641-32024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
71335-0641-42024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
71335-0641-52024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
71335-0641-62024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
71335-0641-72024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
71335-0641-82024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
71335-0641-92024-01-30C16284748780-11030e365-51eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0641-1Dicyclomine Hydrochloride30 in 1 BOTTLETABLET305
71335-0641-2Dicyclomine Hydrochloride40 in 1 BOTTLETABLET405
71335-0641-3Dicyclomine Hydrochloride60 in 1 BOTTLETABLET605
71335-0641-4Dicyclomine Hydrochloride90 in 1 BOTTLETABLET905
71335-0641-5Dicyclomine Hydrochloride20 in 1 BOTTLETABLET205
71335-0641-6Dicyclomine Hydrochloride21 in 1 BOTTLETABLET215
71335-0641-7Dicyclomine Hydrochloride120 in 1 BOTTLETABLET1205
71335-0641-8Dicyclomine Hydrochloride100 in 1 BOTTLETABLET1005
71335-0641-9Dicyclomine Hydrochloride28 in 1 BOTTLETABLET285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0641DICYCLOMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]5Legacy NDC, 9 package rows20220129_b90756d4-db4b-496b-9ad1-12978bdc3d3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNb90756d4-db4b-496b-9ad1-12978bdc3d3d5
991086dicyclomine hydrochloride 20 MG Oral TabletSCDb90756d4-db4b-496b-9ad1-12978bdc3d3d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0641-17133506410130 TABLET in 1 BOTTLE (71335-0641-1) 30 tablet2010-03-220000-00-00NoNoCurrent
71335-0641-27133506410240 TABLET in 1 BOTTLE (71335-0641-2) 40 tablet2010-03-220000-00-00NoNoCurrent
71335-0641-37133506410360 TABLET in 1 BOTTLE (71335-0641-3) 60 tablet2010-03-220000-00-00NoNoCurrent
71335-0641-47133506410490 TABLET in 1 BOTTLE (71335-0641-4) 90 tablet2010-03-220000-00-00NoNoCurrent
71335-0641-57133506410520 TABLET in 1 BOTTLE (71335-0641-5) 20 tablet2010-03-220000-00-00NoNoCurrent
71335-0641-67133506410621 TABLET in 1 BOTTLE (71335-0641-6) 21 tablet2010-03-220000-00-00NoNoCurrent
71335-0641-771335064107120 TABLET in 1 BOTTLE (71335-0641-7) 120 tablet2010-03-220000-00-00NoNoCurrent
71335-0641-871335064108100 TABLET in 1 BOTTLE (71335-0641-8) 100 tablet2010-03-220000-00-00NoNoCurrent
71335-0641-97133506410928 TABLET in 1 BOTTLE (71335-0641-9) 28 tablet2010-03-220000-00-00NoNoCurrent