Dutasteride

Product NDC
50090-7852
11-digit product format
500907852
Labeler code
50090
Product ID
50090-7852_067a71d1-2d8f-4ca2-acb9-06718a5eb8c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209909
Marketing category
ANDA
Marketing start
2017-11-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dutasteride
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7852-0Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED303
50090-7852-1Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7852-0EA - Each50090-785288b2e385-ebfc-4aa8-90a9-fad205e2159312026-02-05
50090-7852-1EA - Each50090-785208d23e75-214c-47c1-8594-4a2c1632382e12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSNaf338f55-55c1-4034-9c27-c3564addf24e3
351172dutasteride 0.5 MG Oral CapsuleSCDaf338f55-55c1-4034-9c27-c3564addf24e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7852-05009078520030 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7852-0) 2026-01-08NoNoHistorical
50090-7852-15009078520190 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7852-1) 2026-01-08NoNoHistorical