FDA.reportPublic FDA data

Dutasteride

Product NDC
71205-278
11-digit product format
712050278
Labeler code
71205
Product ID
71205-278_85ae04d1-a76d-49b9-bb46-8dd37e7881a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-278-30Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED306
71205-278-60Dutasteride60 in 1 BOTTLECAPSULE, LIQUID FILLED606
71205-278-90Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-278-90EA - Each71205-2782a0c4d13-a32b-4e03-bc0c-81132168275012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-278DUTASTERIDE CAPSULE, LIQUID FILLED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20241020_908832b2-21d6-48ae-89cb-f06687321f74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSN908832b2-21d6-48ae-89cb-f06687321f746
351172dutasteride 0.5 MG Oral CapsuleSCD908832b2-21d6-48ae-89cb-f06687321f746

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-278-307120502783030 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-30) 2019-05-010000-00-00NoNoCurrent
71205-278-607120502786060 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-60) 2019-05-010000-00-00NoNoCurrent
71205-278-907120502789090 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-90) 2019-05-010000-00-00NoNoCurrent