FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
59651-720
11-digit product format
596510720
Labeler code
59651
Product ID
59651-720_d81b93f8-bebc-455e-82b6-9a3de3f82e92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA040317
Marketing category
ANDA
Marketing start
2023-04-25
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-720-01Dicyclomine Hydrochloride100 in 1 BOTTLETABLET1001
59651-720-99Dicyclomine Hydrochloride1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-720-01EA - Each59651-7204c17c70e-c8d5-4dac-a0dd-4d1509c5416d12023-09-05
59651-720-99EA - Each59651-7206324d8bc-9174-4d6b-ab5a-a014ab214ac612023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-720DICYCLOMINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230523_d81b93f8-bebc-455e-82b6-9a3de3f82e92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN5734fac5-893d-4afd-95a1-e7ab4fd1df3a100
991086dicyclomine HCl 20 MG Oral TabletPSN226a3a6e-9419-448a-827f-01199b792762100
991086dicyclomine hydrochloride 20 MG Oral TabletSCD5734fac5-893d-4afd-95a1-e7ab4fd1df3a100
991086dicyclomine hydrochloride 20 MG Oral TabletSCD226a3a6e-9419-448a-827f-01199b792762100
991086dicyclomine HCl 20 MG Oral TabletPSN3252540c-980d-40ca-e063-6394a90ad1c94
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3252540c-980d-40ca-e063-6394a90ad1c94
991086dicyclomine HCl 20 MG Oral TabletPSN0d07a460-5cb1-cd4b-e063-6294a90a291d2
991086dicyclomine hydrochloride 20 MG Oral TabletSCD0d07a460-5cb1-cd4b-e063-6294a90a291d2
991086dicyclomine HCl 20 MG Oral TabletPSN1b420733-b3b7-e504-e063-6394a90abba71
991086dicyclomine HCl 20 MG Oral TabletPSN5025a55d-ff55-c810-e063-6294a90adfb31
991086dicyclomine HCl 20 MG Oral TabletPSN1b2d5256-b75d-11f8-e063-6394a90ae9ed1
991086dicyclomine HCl 20 MG Oral TabletPSN62be6437-db8c-431b-8e5f-780487cf2d431
991086dicyclomine HCl 20 MG Oral TabletPSNd81b93f8-bebc-455e-82b6-9a3de3f82e921
991086dicyclomine hydrochloride 20 MG Oral TabletSCD1b420733-b3b7-e504-e063-6394a90abba71
991086dicyclomine hydrochloride 20 MG Oral TabletSCD1b2d5256-b75d-11f8-e063-6394a90ae9ed1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD5025a55d-ff55-c810-e063-6294a90adfb31
991086dicyclomine hydrochloride 20 MG Oral TabletSCD62be6437-db8c-431b-8e5f-780487cf2d431
991086dicyclomine hydrochloride 20 MG Oral TabletSCDd81b93f8-bebc-455e-82b6-9a3de3f82e921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-720-0159651072001100 TABLET in 1 BOTTLE (59651-720-01) 100 tablet2023-04-25NoNoHistorical
59651-720-99596510720991000 TABLET in 1 BOTTLE (59651-720-99) 1000 tablet2023-04-25NoNoHistorical