DICYCLOMINE HYDROCHLORIDE

Product NDC
61919-904
11-digit product format
619190904
Labeler code
61919
Product ID
61919-904_b8b66962-7e29-438c-e053-2a95a90a0e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040230
Marketing category
ANDA
Marketing start
2018-03-14
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
2022-12-31
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
61919-904-20DICYCLOMINE HYDROCHLORIDE20 in 1 BOTTLETABLET203
61919-904-30DICYCLOMINE HYDROCHLORIDE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-904-20EA - Each61919-904479bfe39-c47c-4d96-af16-38866232e20812019-09-05
61919-904-30EA - Each61919-90490048654-651c-41ba-8cc7-e0963d5acaaf12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-904DICYCLOMINE HYDROCHLORIDE TABLET [DIRECT_RX]3Legacy NDC, 1 package rows20210113_902948bc-fecd-5c56-e053-2995a90afb6e.zip
61919-904DICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20210113_676078a3-13e5-cc32-e053-2a91aa0ac75f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN902948bc-fecd-5c56-e053-2995a90afb6e3
991086dicyclomine hydrochloride 20 MG Oral TabletSCD902948bc-fecd-5c56-e053-2995a90afb6e3
991086dicyclomine HCl 20 MG Oral TabletPSN676078a3-13e5-cc32-e053-2a91aa0ac75f2
991086dicyclomine hydrochloride 20 MG Oral TabletSCD676078a3-13e5-cc32-e053-2a91aa0ac75f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-904-206191909042020 TABLET in 1 BOTTLE (61919-904-20) 20 tablet2019-08-150000-00-00NoNoCurrent
61919-904-306191909043030 TABLET in 1 BOTTLE (61919-904-30) 30 tablet2018-03-140000-00-00NoNoCurrent