Dicyclomine

Product NDC
68071-3782
11-digit product format
680713782
Labeler code
68071
Product ID
68071-3782_2eea79bd-1ae0-765d-e063-6294a90a16f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA040161
Marketing category
ANDA
Marketing start
1996-10-01
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
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
68071-3782-3Dicyclomine30 in 1 BOTTLE, PLASTICTABLET302
68071-3782-6Dicyclomine60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3782DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [NUCARE PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250226_2c656550-7e5b-445f-e063-6294a90a8f52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN2c656550-7e5b-445f-e063-6294a90a8f522
991086dicyclomine hydrochloride 20 MG Oral TabletSCD2c656550-7e5b-445f-e063-6294a90a8f522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3782-36807137820330 TABLET in 1 BOTTLE, PLASTIC (68071-3782-3) 30 tablet2025-01-23NoNoHistorical
68071-3782-66807137820660 TABLET in 1 BOTTLE, PLASTIC (68071-3782-6) 60 tablet2025-02-24NoNoHistorical