FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
68071-3255
11-digit product format
680713255
Labeler code
68071
Product ID
68071-3255_1cc31537-db23-8244-e063-6394a90a3797
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA085223
Marketing category
ANDA
Marketing start
1986-07-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

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
68071-3255-12024-07-08C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-22024-07-08C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-32024-07-08C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-52024-07-08C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-62024-07-08C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-82024-07-08C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-92024-07-08C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-12023-01-30C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-22023-01-30C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-32023-01-30C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-52023-01-30C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-62023-01-30C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-82023-01-30C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-92023-01-30C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-12021-02-10C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-22021-02-10C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-32021-02-10C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-52021-02-10C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-62021-02-10C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-82021-02-10C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-92021-02-10C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-12021-01-29C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-22021-01-29C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-32021-01-29C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-52021-01-29C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-62021-01-29C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-82021-01-29C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-92021-01-29C16284748780-1ba0f9c33-1a3f-a910-e053-dadaa90a0b85These 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
68071-3255-1Dicyclomine Hydrochloride10 in 1 BOTTLETABLET105
68071-3255-2Dicyclomine Hydrochloride20 in 1 BOTTLETABLET205
68071-3255-3Dicyclomine Hydrochloride30 in 1 BOTTLETABLET305
68071-3255-5Dicyclomine Hydrochloride15 in 1 BOTTLETABLET155
68071-3255-6Dicyclomine Hydrochloride60 in 1 BOTTLETABLET605
68071-3255-8Dicyclomine Hydrochloride28 in 1 BOTTLETABLET285
68071-3255-9Dicyclomine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3255DICYCLOMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 7 package rows20240709_517646d8-366e-5cf2-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN517646d8-366e-5cf2-e054-00144ff88e885
991086dicyclomine hydrochloride 20 MG Oral TabletSCD517646d8-366e-5cf2-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3255-16807132550110 TABLET in 1 BOTTLE (68071-3255-1) 10 tablet2017-06-080000-00-00NoNoCurrent
68071-3255-26807132550220 TABLET in 1 BOTTLE (68071-3255-2) 20 tablet2017-06-080000-00-00NoNoCurrent
68071-3255-36807132550330 TABLET in 1 BOTTLE (68071-3255-3) 30 tablet2017-06-080000-00-00NoNoCurrent
68071-3255-56807132550515 TABLET in 1 BOTTLE (68071-3255-5) 15 tablet2017-06-080000-00-00NoNoCurrent
68071-3255-66807132550660 TABLET in 1 BOTTLE (68071-3255-6) 60 tablet2017-06-080000-00-00NoNoCurrent
68071-3255-86807132550828 TABLET in 1 BOTTLE (68071-3255-8) 28 tablet2017-06-080000-00-00NoNoCurrent
68071-3255-96807132550990 TABLET in 1 BOTTLE (68071-3255-9) 90 tablet2017-06-080000-00-00NoNoCurrent