FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
68071-3310
11-digit product format
680713310
Labeler code
68071
Product ID
68071-3310_1cd6f253-6641-e75d-e063-6294a90a5b05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA085082
Marketing category
ANDA
Marketing start
1986-06-19
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 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
68071-3310-12024-07-09C16284748780-1ba0f9c33-0dae-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
68071-3310-32024-07-09C16284748780-1ba0f9c33-0dae-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
68071-3310-62024-07-09C16284748780-1ba0f9c33-0dae-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
68071-3310-92024-07-09C16284748780-1ba0f9c33-0dae-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
68071-3310-12023-01-30C16284748780-1ba0f9c33-0dae-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
68071-3310-32023-01-30C16284748780-1ba0f9c33-0dae-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
68071-3310-62023-01-30C16284748780-1ba0f9c33-0dae-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
68071-3310-92023-01-30C16284748780-1ba0f9c33-0dae-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
68071-3310-12021-02-12C16284748780-1ba0f9c33-0dae-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
68071-3310-32021-02-12C16284748780-1ba0f9c33-0dae-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
68071-3310-62021-02-12C16284748780-1ba0f9c33-0dae-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
68071-3310-92021-02-12C16284748780-1ba0f9c33-0dae-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
68071-3310-12021-01-29C16284748780-1ba0f9c33-0dae-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
68071-3310-32021-01-29C16284748780-1ba0f9c33-0dae-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
68071-3310-62021-01-29C16284748780-1ba0f9c33-0dae-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
68071-3310-92021-01-29C16284748780-1ba0f9c33-0dae-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
68071-3310-1Dicyclomine Hydrochloride16 in 1 BOTTLECAPSULE163
68071-3310-3Dicyclomine Hydrochloride30 in 1 BOTTLECAPSULE303
68071-3310-6Dicyclomine Hydrochloride60 in 1 BOTTLECAPSULE603
68071-3310-9Dicyclomine Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3310DICYCLOMINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20240711_51742add-363d-3f9d-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN51742add-363d-3f9d-e054-00144ff8d46c3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD51742add-363d-3f9d-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3310-16807133100116 CAPSULE in 1 BOTTLE (68071-3310-1) 16 capsule2017-06-080000-00-00NoNoCurrent
68071-3310-36807133100330 CAPSULE in 1 BOTTLE (68071-3310-3) 30 capsule2017-06-080000-00-00NoNoCurrent
68071-3310-66807133100660 CAPSULE in 1 BOTTLE (68071-3310-6) 60 capsule2017-06-080000-00-00NoNoCurrent
68071-3310-96807133100990 CAPSULE in 1 BOTTLE (68071-3310-9) 90 capsule2017-06-080000-00-00NoNoCurrent