FDA.reportPublic FDA data

Dutasteride

Product NDC
50090-4010
11-digit product format
500904010
Labeler code
50090
Product ID
50090-4010_20bcd517-c1c4-48be-8cfe-778fdd463d19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206574
Marketing category
ANDA
Marketing start
2016-10-24
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
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4010-02023-02-07C16284748780-1f386c649-f65d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001
50090-4010-12023-02-07C16284748780-1f386c649-f65d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001
50090-4010-02023-01-30C16284748780-1f386c649-f65d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001
50090-4010-12023-01-30C16284748780-1f386c649-f65d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4010-0Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED3010
50090-4010-1Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4010-0EA - Each50090-401062dfa525-4f17-4be1-a6c4-6a0b92c9a9fd12022-01-06
50090-4010-1EA - Each50090-40107d777979-1454-4462-83c5-5b6c31d4a96b12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4010DUTASTERIDE CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20240329_af5e7d42-6953-4b7f-afac-257e9444b0a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSNaf5e7d42-6953-4b7f-afac-257e9444b0a210
351172dutasteride 0.5 MG Oral CapsuleSCDaf5e7d42-6953-4b7f-afac-257e9444b0a210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4010-05009040100030 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4010-0) 2018-12-280000-00-00NoNoCurrent
50090-4010-15009040100190 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4010-1) 2019-07-010000-00-00NoNoCurrent