FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
68071-4782
11-digit product format
680714782
Labeler code
68071
Product ID
68071-4782_21f06630-bb01-ed32-e063-6294a90ac95b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040230
Marketing category
ANDA
Marketing start
1999-02-26
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

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
68071-4782-12024-06-14C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-22024-06-14C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-32024-06-14C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-62024-06-14C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-92024-06-14C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-12023-01-30C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-22023-01-30C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-32023-01-30C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-62023-01-30C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-92023-01-30C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-32021-03-24C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
68071-4782-32021-01-29C16284748780-1ba0f9c33-3b04-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4782-1Dicyclomine Hydrochloride10 in 1 BOTTLETABLET105
68071-4782-2Dicyclomine Hydrochloride20 in 1 BOTTLETABLET205
68071-4782-3Dicyclomine Hydrochloride30 in 1 BOTTLETABLET305
68071-4782-6Dicyclomine Hydrochloride60 in 1 BOTTLETABLET605
68071-4782-9Dicyclomine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4782DICYCLOMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 5 package rows20240913_82832a91-d16c-3a63-e053-2a91aa0a3ffb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN82832a91-d16c-3a63-e053-2a91aa0a3ffb5
991086dicyclomine hydrochloride 20 MG Oral TabletSCD82832a91-d16c-3a63-e053-2a91aa0a3ffb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4782-16807147820110 TABLET in 1 BOTTLE (68071-4782-1) 10 tablet2019-02-220000-00-00NoNoCurrent
68071-4782-26807147820220 TABLET in 1 BOTTLE (68071-4782-2) 20 tablet2019-02-220000-00-00NoNoCurrent
68071-4782-36807147820330 TABLET in 1 BOTTLE (68071-4782-3) 30 tablet2019-02-220000-00-00NoNoCurrent
68071-4782-66807147820660 TABLET in 1 BOTTLE (68071-4782-6) 60 tablet2019-02-220000-00-00NoNoCurrent
68071-4782-96807147820990 TABLET in 1 BOTTLE (68071-4782-9) 90 tablet2019-02-220000-00-00NoNoCurrent