FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
59651-719
11-digit product format
596510719
Labeler code
59651
Product ID
59651-719_ec746016-eed0-4e37-bb9c-cb430c8a7f07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA040319
Marketing category
ANDA
Marketing start
2023-05-08
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991061

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
59651-719-01Dicyclomine Hydrochloride100 in 1 BOTTLECAPSULE1001
59651-719-99Dicyclomine Hydrochloride1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-719-01EA - Each59651-7194e1d7469-c680-4242-8f4d-0a820351e55412023-09-05
59651-719-99EA - Each59651-719c832e100-88c9-4b69-8f36-0f42757a045112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-719DICYCLOMINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230523_ec746016-eed0-4e37-bb9c-cb430c8a7f07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN07361f0e-90c7-4531-8d3f-1ec5e7fed40d101
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD07361f0e-90c7-4531-8d3f-1ec5e7fed40d101
991061dicyclomine HCl 10 MG Oral CapsulePSN21ec88b3-22c7-492b-bfb1-73d3f9852522100
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD21ec88b3-22c7-492b-bfb1-73d3f9852522100
991061dicyclomine HCl 10 MG Oral CapsulePSN115dbb2f-e8f7-2189-e063-6294a90aacd73
991061dicyclomine HCl 10 MG Oral CapsulePSNa5864c57-d73c-45c6-8985-7a041c84ccad3
991061dicyclomine HCl 10 MG Oral CapsulePSNe67ad329-6395-4fa0-a898-f13959034e263
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD115dbb2f-e8f7-2189-e063-6294a90aacd73
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDa5864c57-d73c-45c6-8985-7a041c84ccad3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDe67ad329-6395-4fa0-a898-f13959034e263
991061dicyclomine HCl 10 MG Oral CapsulePSN20ef2c05-d0a4-405c-e063-6394a90ae6971
991061dicyclomine HCl 10 MG Oral CapsulePSN508a7d45-4efd-8532-e063-6294a90a77411
991061dicyclomine HCl 10 MG Oral CapsulePSNec746016-eed0-4e37-bb9c-cb430c8a7f071
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD20ef2c05-d0a4-405c-e063-6394a90ae6971
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD508a7d45-4efd-8532-e063-6294a90a77411
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDec746016-eed0-4e37-bb9c-cb430c8a7f071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-719-0159651071901100 CAPSULE in 1 BOTTLE (59651-719-01) 100 capsule2023-05-08NoNoHistorical
59651-719-99596510719991000 CAPSULE in 1 BOTTLE (59651-719-99) 1000 capsule2023-05-08NoNoHistorical