FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
50090-7309
11-digit product format
500907309
Labeler code
50090
Product ID
50090-7309_bbfd15b7-d21a-461b-a4f2-3cfa965ff6b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA216782
Marketing category
ANDA
Marketing start
2023-07-01
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
50090-7309-0Dicyclomine Hydrochloride30 in 1 BOTTLETABLET303
50090-7309-2Dicyclomine Hydrochloride20 in 1 BOTTLETABLET203
50090-7309-8Dicyclomine Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7309-0EA - Each50090-7309c96d8049-8fd8-41e0-a743-4b4e76975d3112024-11-05
50090-7309-2EA - Each50090-73092678daea-71ea-49b7-9c0e-c471f59b259b12024-11-05
50090-7309-8EA - Each50090-7309dccb52ba-22a4-41a3-8471-3913cb6d95c612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7309DICYCLOMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241018_1aebc66d-0636-45ef-8110-7ff49d4dced5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN1aebc66d-0636-45ef-8110-7ff49d4dced53
991086dicyclomine hydrochloride 20 MG Oral TabletSCD1aebc66d-0636-45ef-8110-7ff49d4dced53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7309-05009073090030 TABLET in 1 BOTTLE (50090-7309-0) 30 tablet2024-10-14NoNoCurrent
50090-7309-25009073090220 TABLET in 1 BOTTLE (50090-7309-2) 20 tablet2024-10-14NoNoCurrent
50090-7309-85009073090890 TABLET in 1 BOTTLE (50090-7309-8) 90 tablet2024-10-14NoNoCurrent