FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
51407-783
11-digit product format
514070783
Labeler code
51407
Product ID
51407-783_014152a7-2595-6a86-e063-6394a90a6a17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA040204
Marketing category
ANDA
Marketing start
1997-02-28
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
51407-783-01Dicyclomine hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
51407-783-10Dicyclomine hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-783-01EA - Each51407-783eda68db6-7b64-4dcc-8d5a-50aea55fb66912023-08-08
51407-783-10EA - Each51407-783b215830d-b16f-4818-a4d2-68afd0f8130012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-783DICYCLOMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 2 package rows20230725_01413a77-48f8-1a8a-e063-6394a90ae494.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN01413a77-48f8-1a8a-e063-6394a90ae4941
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD01413a77-48f8-1a8a-e063-6394a90ae4941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-783-0151407078301100 CAPSULE in 1 BOTTLE, PLASTIC (51407-783-01) 100 capsule2023-07-24NoNoHistorical
51407-783-10514070783101000 CAPSULE in 1 BOTTLE, PLASTIC (51407-783-10) 1000 capsule2023-07-24NoNoHistorical