FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
50090-7732
11-digit product format
500907732
Labeler code
50090
Product ID
50090-7732_a8038b1f-1007-4ee3-be49-65f59b2af34d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-7732-0Dicyclomine hydrochloride30 in 1 BOTTLETABLET301
50090-7732-2Dicyclomine hydrochloride20 in 1 BOTTLETABLET201
50090-7732-8Dicyclomine hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7732-0EA - Each50090-773256f55ebc-435a-4aac-a6fa-091193003c3412025-12-16
50090-7732-2EA - Each50090-7732b8a0299b-47cd-49b0-a43a-bd1afb39252612025-12-16
50090-7732-8EA - Each50090-7732b2360672-b635-4bff-a5a9-189bb1f4268512025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN3713ae82-f36d-4491-9978-3111599ceafb1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3713ae82-f36d-4491-9978-3111599ceafb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7732-05009077320030 TABLET in 1 BOTTLE (50090-7732-0) 30 tablet2025-10-28NoNoCurrent
50090-7732-25009077320220 TABLET in 1 BOTTLE (50090-7732-2) 20 tablet2025-10-28NoNoCurrent
50090-7732-85009077320890 TABLET in 1 BOTTLE (50090-7732-8) 90 tablet2025-10-28NoNoCurrent