Dicyclomine Hydrochloride

Product NDC
67296-2154
11-digit product format
672962154
Labeler code
67296
Product ID
67296-2154_4637deb0-0a45-f07b-e063-6394a90a69fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
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
67296-2154-1Dicyclomine Hydrochloride15 in 1 BOTTLETABLET154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2154DICYCLOMINE HYDROCHLORIDE TABLET [REDPHARM DRUG]1Current NDC, 1 package rows20250410_3252540c-980d-40ca-e063-6394a90ad1c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN3252540c-980d-40ca-e063-6394a90ad1c94
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3252540c-980d-40ca-e063-6394a90ad1c94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2154-16729621540115 TABLET in 1 BOTTLE (67296-2154-1) 15 tablet2023-04-25NoNoHistorical