Dicyclomine Hydrochloride

Product NDC
21695-219
11-digit product format
216950219
Labeler code
21695
Product ID
21695-219_8a8a81a4-6768-4ec0-b6ad-224788bcc59a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040230
Marketing category
ANDA
Marketing start
1999-02-26
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-219-202019-09-24C16284748780-1934fe258-48bd-48b1-e053-8cdaa90a720aDicyclomine Hydrochloride
21695-219-302019-09-24C16284748780-1934fe258-48bd-48b1-e053-8cdaa90a720aDicyclomine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-219-20Dicyclomine Hydrochloride20 in 1 BOTTLETABLET202
21695-219-30Dicyclomine Hydrochloride30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-219DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20111108_57ab6992-7b98-4503-b4bb-98d76ccf603e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN57ab6992-7b98-4503-b4bb-98d76ccf603e2
991086dicyclomine hydrochloride 20 MG Oral TabletSCD57ab6992-7b98-4503-b4bb-98d76ccf603e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-219-202169502192020 in 1 BOTTLEHistorical
21695-219-302169502193030 in 1 BOTTLEHistorical