Dicyclomine Hydrochloride

Product NDC
53808-0233
11-digit product format
538080233
Labeler code
53808
Product ID
53808-0233_6f87d871-e2de-4445-9ecf-d00bfeb0afec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA085082
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
53808-0233-1Dicyclomine Hydrochloride30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0233DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_f325dd3d-8ebe-4aa3-8c45-43438c75defe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991086dicyclomine HCl 20 MG Oral TabletPSNf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991086dicyclomine hydrochloride 20 MG Oral TabletSCDf325dd3d-8ebe-4aa3-8c45-43438c75defe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0233-15380802330130 in 1 BLISTER PACKHistorical