Dicyclomine Hydrochloride

Product NDC
53217-324
11-digit product format
532170324
Labeler code
53217
Product ID
53217-324_30e2e320-f057-4ee0-9b38-6b329e271d15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA085223
Marketing category
ANDA
Marketing start
2017-06-14
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-324-24Dicyclomine Hydrochloride24 in 1 BOTTLE, PLASTICTABLET244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-324DICYCLOMINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20180523_27c67441-0e12-47e9-9157-26af00065a0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN27c67441-0e12-47e9-9157-26af00065a0e4
991086dicyclomine hydrochloride 20 MG Oral TabletSCD27c67441-0e12-47e9-9157-26af00065a0e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-324-245321703242424 in 1 BOTTLE, PLASTICHistorical