FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
53002-3290
11-digit product format
530023290
Labeler code
53002
Product ID
53002-3290_29a0eadf-ea2e-46b6-aeca-2618d5d47ff3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA085082
Marketing category
ANDA
Marketing start
1986-06-19
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-3290-12025-01-30C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-22025-01-30C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-32025-01-30C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-12023-06-07C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-22023-06-07C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-32023-06-07C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-12023-01-30C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-22023-01-30C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-32023-01-30C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-12020-12-15C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-22020-12-15C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-32020-12-15C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-12020-01-31C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-22020-01-31C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-32020-01-31C16284748780-19d75b9d0-bc95-f424-e053-dadaa90a57ceThese 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
53002-3290-1Dicyclomine Hydrochloride10 in 1 BOTTLECAPSULE108
53002-3290-2Dicyclomine Hydrochloride20 in 1 BOTTLECAPSULE208
53002-3290-3Dicyclomine Hydrochloride30 in 1 BOTTLECAPSULE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3290DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]8Legacy NDC, 3 package rows20230609_7cbefee1-1b23-4e9b-8527-ec357a9dbcb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN7cbefee1-1b23-4e9b-8527-ec357a9dbcb68
991086dicyclomine HCl 20 MG Oral TabletPSN7cbefee1-1b23-4e9b-8527-ec357a9dbcb68
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD7cbefee1-1b23-4e9b-8527-ec357a9dbcb68
991086dicyclomine hydrochloride 20 MG Oral TabletSCD7cbefee1-1b23-4e9b-8527-ec357a9dbcb68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3290-15300232900110 CAPSULE in 1 BOTTLE (53002-3290-1) 10 capsule2018-10-010000-00-00NoNoCurrent
53002-3290-25300232900220 CAPSULE in 1 BOTTLE (53002-3290-2) 20 capsule2018-10-010000-00-00NoNoCurrent
53002-3290-35300232900330 CAPSULE in 1 BOTTLE (53002-3290-3) 30 capsule2018-10-010000-00-00NoNoCurrent