FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
67046-118
11-digit product format
670460118
Labeler code
67046
Product ID
67046-118_59ca0395-599c-0d7e-e053-2a91aa0a2c91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA085223
Marketing category
ANDA
Marketing start
2017-09-21
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
2020-12-31
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
67046-118-072022-01-28C16284748780-1d6a99b39-9c82-a426-e053-dadaa90af4c2123 Dicyclomine 10 mg 118 Dicyclomine 20 mg These 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
67046-118-142022-01-28C16284748780-1d6a99b39-9c82-a426-e053-dadaa90af4c2123 Dicyclomine 10 mg 118 Dicyclomine 20 mg These 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
67046-118-152022-01-28C16284748780-1d6a99b39-9c82-a426-e053-dadaa90af4c2123 Dicyclomine 10 mg 118 Dicyclomine 20 mg These 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
67046-118-202022-01-28C16284748780-1d6a99b39-9c82-a426-e053-dadaa90af4c2123 Dicyclomine 10 mg 118 Dicyclomine 20 mg These 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
67046-118-212022-01-28C16284748780-1d6a99b39-9c82-a426-e053-dadaa90af4c2123 Dicyclomine 10 mg 118 Dicyclomine 20 mg These 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
67046-118-282022-01-28C16284748780-1d6a99b39-9c82-a426-e053-dadaa90af4c2123 Dicyclomine 10 mg 118 Dicyclomine 20 mg These 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
67046-118-302022-01-28C16284748780-1d6a99b39-9c82-a426-e053-dadaa90af4c2123 Dicyclomine 10 mg 118 Dicyclomine 20 mg These 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
67046-118-602022-01-28C16284748780-1d6a99b39-9c82-a426-e053-dadaa90af4c2123 Dicyclomine 10 mg 118 Dicyclomine 20 mg These 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
67046-118-07Dicyclomine Hydrochloride7 in 1 BLISTER PACKTABLET71
67046-118-14Dicyclomine Hydrochloride14 in 1 BLISTER PACKTABLET141
67046-118-15Dicyclomine Hydrochloride15 in 1 BLISTER PACKTABLET151
67046-118-20Dicyclomine Hydrochloride20 in 1 BLISTER PACKTABLET201
67046-118-21Dicyclomine Hydrochloride21 in 1 BLISTER PACKTABLET211
67046-118-28Dicyclomine Hydrochloride28 in 1 BLISTER PACKTABLET281
67046-118-30Dicyclomine Hydrochloride30 in 1 BLISTER PACKTABLET301
67046-118-60Dicyclomine Hydrochloride60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-118DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170922_59ca0395-599b-0d7e-e053-2a91aa0a2c91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN59ca0395-599b-0d7e-e053-2a91aa0a2c911
991086dicyclomine HCl 20 MG Oral TabletPSN59ca0395-599b-0d7e-e053-2a91aa0a2c911
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD59ca0395-599b-0d7e-e053-2a91aa0a2c911
991086dicyclomine hydrochloride 20 MG Oral TabletSCD59ca0395-599b-0d7e-e053-2a91aa0a2c911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-118-07670460118077 TABLET in 1 BLISTER PACK (67046-118-07) 7 tablet2017-09-210000-00-00NoNoCurrent
67046-118-146704601181414 TABLET in 1 BLISTER PACK (67046-118-14) 14 tablet2017-09-210000-00-00NoNoCurrent
67046-118-156704601181515 TABLET in 1 BLISTER PACK (67046-118-15) 15 tablet2017-09-210000-00-00NoNoCurrent
67046-118-206704601182020 TABLET in 1 BLISTER PACK (67046-118-20) 20 tablet2017-09-210000-00-00NoNoCurrent
67046-118-216704601182121 TABLET in 1 BLISTER PACK (67046-118-21) 21 tablet2017-09-210000-00-00NoNoCurrent
67046-118-286704601182828 TABLET in 1 BLISTER PACK (67046-118-28) 28 tablet2017-09-210000-00-00NoNoCurrent
67046-118-306704601183030 TABLET in 1 BLISTER PACK (67046-118-30) 30 tablet2017-09-210000-00-00NoNoCurrent
67046-118-606704601186060 TABLET in 1 BLISTER PACK (67046-118-60) 60 tablet2017-09-210000-00-00NoNoCurrent