FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
72888-198
11-digit product format
728880198
Labeler code
72888
Product ID
72888-198_4b7e07c5-f687-74a5-e063-6294a90aa7ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd.,
Application
ANDA216736
Marketing category
ANDA
Marketing start
2025-03-25
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086, 2719470

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
72888-198-00Dicyclomine hydrochloride1000 in 1 BOTTLETABLET10003
72888-198-01Dicyclomine hydrochloride100 in 1 BOTTLETABLET1003
72888-198-05Dicyclomine hydrochloride500 in 1 BOTTLETABLET5003
72888-198-12Dicyclomine hydrochloride120 in 1 BOTTLETABLET1203
72888-198-30Dicyclomine hydrochloride30 in 1 BOTTLETABLET303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNb4331e24-58af-45fb-a25b-9eb8270f83f73
2719470dicyclomine hydrochloride 40 MG Oral TabletPSNb4331e24-58af-45fb-a25b-9eb8270f83f73
991086dicyclomine hydrochloride 20 MG Oral TabletSCDb4331e24-58af-45fb-a25b-9eb8270f83f73
2719470dicyclomine hydrochloride 40 MG Oral TabletSCDb4331e24-58af-45fb-a25b-9eb8270f83f73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-198-00728880198001000 TABLET in 1 BOTTLE (72888-198-00) 1000 tablet2025-03-25NoNoCurrent
72888-198-0172888019801100 TABLET in 1 BOTTLE (72888-198-01) 100 tablet2025-03-25NoNoCurrent
72888-198-0572888019805500 TABLET in 1 BOTTLE (72888-198-05) 500 tablet2025-03-25NoNoCurrent
72888-198-1272888019812120 TABLET in 1 BOTTLE (72888-198-12) 120 tablet2025-03-25NoNoCurrent
72888-198-307288801983030 TABLET in 1 BOTTLE (72888-198-30) 30 tablet2026-02-17NoNoCurrent