FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
67296-2142
11-digit product format
672962142
Labeler code
67296
Product ID
67296-2142_46c3434c-05fb-106d-e063-6394a90a4b36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA216736
Marketing category
ANDA
Marketing start
2022-12-14
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
67296-2142-1Dicyclomine hydrochloride10 in 1 BOTTLETABLET104
67296-2142-2Dicyclomine hydrochloride15 in 1 BOTTLETABLET154
67296-2142-5Dicyclomine hydrochloride15 in 1 BOTTLETABLET154
67296-2142-6Dicyclomine hydrochloride6 in 1 BOTTLETABLET64

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN3b0ae3ed-77ef-d0df-e063-6294a90a7d174
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3b0ae3ed-77ef-d0df-e063-6294a90a7d174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2142-16729621420110 TABLET in 1 BOTTLE (67296-2142-1) 10 tablet2022-12-14NoNoHistorical
67296-2142-26729621420215 TABLET in 1 BOTTLE (67296-2142-2) 15 tablet2022-12-14NoNoHistorical
67296-2142-56729621420515 TABLET in 1 BOTTLE (67296-2142-5) 15 tablet2022-12-14NoNoHistorical
67296-2142-6672962142066 TABLET in 1 BOTTLE (67296-2142-6) 6 tablet2022-12-14NoNoHistorical