Dicyclomine Hydrochloride

Product NDC
0904-6987
11-digit product format
009046987
Labeler code
0904
Product ID
0904-6987_5d042b74-77b3-401e-b019-4807df743055
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA084285
Marketing category
ANDA
Marketing start
1999-02-26
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, 991086

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
0904-6987-61Dicyclomine Hydrochloride1 in 1 BLISTER PACKCAPSULE16
0904-6987-61Dicyclomine Hydrochloride100 in 1 CARTONCAPSULE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6987-61EA - Each0904-698700bd53b7-ca00-4f10-bb8e-1ce52efba00b12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6987DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250212_5eee0dff-d157-4534-adfb-c035b7042c07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN5eee0dff-d157-4534-adfb-c035b7042c076
991061dicyclomine HCl 10 MG Oral CapsulePSN793a3f0c-ea45-4e28-a98a-610cf9eddad86
991086dicyclomine HCl 20 MG Oral TabletPSN5eee0dff-d157-4534-adfb-c035b7042c076
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD5eee0dff-d157-4534-adfb-c035b7042c076
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD793a3f0c-ea45-4e28-a98a-610cf9eddad86
991086dicyclomine hydrochloride 20 MG Oral TabletSCD5eee0dff-d157-4534-adfb-c035b7042c076

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6987-6100904698761100 BLISTER PACK in 1 CARTON (0904-6987-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack1999-02-260000-00-00NoNoCurrent