FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
50090-7882
11-digit product format
500907882
Labeler code
50090
Product ID
50090-7882_467686e1-3c55-443b-9663-f38fdca20447
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA217916
Marketing category
ANDA
Marketing start
2023-09-13
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 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 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
50090-7882-0Dicyclomine Hydrochloride30 in 1 BOTTLETABLET301
50090-7882-2Dicyclomine Hydrochloride20 in 1 BOTTLETABLET201
50090-7882-8Dicyclomine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7882-0EA - Each50090-78827e8ab1e0-67e6-4e58-8b1b-2d3bcffe8ad112026-03-17
50090-7882-2EA - Each50090-788227046e2a-2522-4dd2-9a0f-e30adfb898f512026-03-17
50090-7882-8EA - Each50090-78822612095d-5049-4269-89fb-c8a620967ae612026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN2b33ef28-2b71-46c4-bb2f-694fefcd59ab1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD2b33ef28-2b71-46c4-bb2f-694fefcd59ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7882-05009078820030 TABLET in 1 BOTTLE (50090-7882-0) 30 tablet2026-02-04NoNoHistorical
50090-7882-25009078820220 TABLET in 1 BOTTLE (50090-7882-2) 20 tablet2026-02-04NoNoHistorical
50090-7882-85009078820890 TABLET in 1 BOTTLE (50090-7882-8) 90 tablet2026-02-04NoNoHistorical