FDA.reportPublic FDA data

Dutasteride

Product NDC
50090-7305
11-digit product format
500907305
Labeler code
50090
Product ID
50090-7305_c9fdff9e-14e3-4d2a-80d2-8c93ed67b459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202660
Marketing category
ANDA
Marketing start
2023-01-20
Substance
DUTASTERIDE
Active strength
.5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dutasteride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DUTASTERIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0J6XJN02I
Rxcui351172

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7305-0Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED305
50090-7305-1Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7305-0EA - Each50090-7305dafcfe0c-87a6-4356-880f-ff7314c0677c12024-11-05
50090-7305-1EA - Each50090-7305fba05844-dc62-4f43-8cb4-cbf5fb35852f12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7305DUTASTERIDE CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]5Current NDC, 2 package rows20241023_468df1b8-1f82-4328-a549-0a716ad1266d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSN468df1b8-1f82-4328-a549-0a716ad1266d5
351172dutasteride 0.5 MG Oral CapsuleSCD468df1b8-1f82-4328-a549-0a716ad1266d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7305-05009073050030 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7305-0) 2024-10-14NoNoCurrent
50090-7305-15009073050190 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7305-1) 2024-10-14NoNoCurrent