FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
53808-0644
11-digit product format
538080644
Labeler code
53808
Product ID
53808-0644_70202a73-7bee-4596-96f8-96154d758841
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA040319
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
2018-12-31
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
53808-0644-12020-01-31C16284748780-19d75b9d0-56d1-f424-e053-dadaa90a57ceb65264c5-2d4a-4290-a084-ddd533e9e954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0644-1Dicyclomine Hydrochloride30 in 1 BLISTER PACKTABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991616dicyclomine HCl 10 MG Oral TabletPSNb65264c5-2d4a-4290-a084-ddd533e9e9542
991616dicyclomine hydrochloride 10 MG Oral TabletSCDb65264c5-2d4a-4290-a084-ddd533e9e9542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0644-15380806440130 in 1 BLISTER PACKHistorical