FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
53217-302
11-digit product format
532170302
Labeler code
53217
Product ID
53217-302_1ae3a9d5-4145-4468-a16a-e6db8a87a180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
2019-12-31
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
53217-302-102020-01-31C16284748780-19d75b9d0-29fb-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
53217-302-212020-01-31C16284748780-19d75b9d0-29fb-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
53217-302-302020-01-31C16284748780-19d75b9d0-29fb-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
53217-302-602020-01-31C16284748780-19d75b9d0-29fb-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
53217-302-902020-01-31C16284748780-19d75b9d0-29fb-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
53217-302-10Dicyclomine Hydrochloride10 in 1 BOTTLE, PLASTICCAPSULE102
53217-302-21Dicyclomine Hydrochloride21 in 1 BOTTLE, PLASTICCAPSULE212
53217-302-30Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE302
53217-302-60Dicyclomine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE602
53217-302-90Dicyclomine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-302-10EA - Each53217-3021f33a79e-3506-47a5-81ab-dffd5ba4692212017-07-07
53217-302-21EA - Each53217-30280ce430a-0935-494a-9f2f-4260885d1e2912017-07-07
53217-302-30EA - Each53217-302c8f1ef10-300f-4e4a-8756-a6ec7e4242cd12017-07-07
53217-302-60EA - Each53217-3020d8f7331-999f-4c89-bfcb-d31e9130b9d112017-07-07
53217-302-90EA - Each53217-3020735f382-8e39-4668-b361-68bc01d539d912017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-302DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 5 package rows20170524_deb3a0bd-220f-4956-9219-bde9a6f0df17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNdeb3a0bd-220f-4956-9219-bde9a6f0df172
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDdeb3a0bd-220f-4956-9219-bde9a6f0df172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-302-105321703021010 in 1 BOTTLE, PLASTICHistorical
53217-302-215321703022121 in 1 BOTTLE, PLASTICHistorical
53217-302-305321703023030 in 1 BOTTLE, PLASTICHistorical
53217-302-605321703026060 in 1 BOTTLE, PLASTICHistorical
53217-302-905321703029090 in 1 BOTTLE, PLASTICHistorical