FDA.reportPublic FDA data

Dicyclomine

Product NDC
50090-5454
11-digit product format
500905454
Labeler code
50090
Product ID
50090-5454_2c3cfba9-854e-4a94-96ee-16614b6433c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040161
Marketing category
ANDA
Marketing start
1996-10-01
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
2023-12-31
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
50090-5454-02024-01-30C16284748780-11030e365-0fe3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-5454-22024-01-30C16284748780-11030e365-0fe3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-5454-82024-01-30C16284748780-11030e365-0fe3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5454-0Dicyclomine30 in 1 BOTTLETABLET306
50090-5454-2Dicyclomine20 in 1 BOTTLETABLET206
50090-5454-8Dicyclomine90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5454-0EA - Each50090-54546c5e4051-9381-450d-9051-248a4bc94b9a12022-12-07
50090-5454-2EA - Each50090-5454548cd78e-b522-41fc-a9e4-d9d15e7c0a1c12022-08-04
50090-5454-8EA - Each50090-54544f74a6f8-bc33-4225-9b84-d7efc101936412022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5454DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC, 3 package rows20220708_b1db8bc1-2fcc-45c3-b49a-c8968649d5e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNb1db8bc1-2fcc-45c3-b49a-c8968649d5e76
991086dicyclomine hydrochloride 20 MG Oral TabletSCDb1db8bc1-2fcc-45c3-b49a-c8968649d5e76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5454-05009054540030 TABLET in 1 BOTTLE (50090-5454-0) 30 tablet2021-01-280000-00-00NoNoCurrent
50090-5454-25009054540220 TABLET in 1 BOTTLE (50090-5454-2) 20 tablet2022-07-070000-00-00NoNoCurrent
50090-5454-85009054540890 TABLET in 1 BOTTLE (50090-5454-8) 90 tablet2021-01-280000-00-00NoNoCurrent