FDA.reportPublic FDA data

Dutasteride

Product NDC
72162-1296
11-digit product format
721621296
Labeler code
72162
Product ID
72162-1296_58ddc8c0-2a8c-4c86-ad7c-81f93d990b8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
72162-1296-3Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED30102
72162-1296-9Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1296-3EA - Each72162-12963c11e4be-4513-43e3-904a-c2ee085745ca12024-01-04
72162-1296-9EA - Each72162-1296dd4ed0af-ce06-4e8d-8441-8165e2c3c2bc12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1296DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240315_3285b390-f531-4e99-9bae-828ac66e874d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSN3285b390-f531-4e99-9bae-828ac66e874d102
351172dutasteride 0.5 MG Oral CapsuleSCD3285b390-f531-4e99-9bae-828ac66e874d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1296-37216212960330 CAPSULE, LIQUID FILLED in 1 BOTTLE (72162-1296-3) 2023-08-30NoNoHistorical
72162-1296-97216212960990 CAPSULE, LIQUID FILLED in 1 BOTTLE (72162-1296-9) 2023-08-30NoNoHistorical