FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
67296-2175
11-digit product format
672962175
Labeler code
67296
Product ID
67296-2175_44f6ca7a-30e8-0d95-e063-6394a90a03d4
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
67296-2175-1Dicyclomine hydrochloride10 in 1 BOTTLETABLET102
67296-2175-2Dicyclomine hydrochloride15 in 1 BOTTLETABLET152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN3de47f8d-e265-3f40-e063-6394a90aa3b02
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3de47f8d-e265-3f40-e063-6394a90aa3b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2175-16729621750110 TABLET in 1 BOTTLE (67296-2175-1) 10 tablet2022-12-14NoNoCurrent
67296-2175-26729621750215 TABLET in 1 BOTTLE (67296-2175-2) 15 tablet2022-12-14NoNoCurrent