FDA.reportPublic FDA data

AVODART

Product NDC
80725-712
11-digit product format
807250712
Labeler code
80725
Product ID
80725-712_52039b4d-0202-4d5b-8790-352d254525d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Waylis Therapeutics LLC
Application
NDA021319
Marketing category
NDA
Marketing start
2022-12-15
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
AVODART
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DUTASTERIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0J6XJN02I
Rxcui351172, 352118

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
80725-712-04AVODART90 in 1 BOTTLECAPSULE, LIQUID FILLED904
80725-712-15AVODART30 in 1 BOTTLECAPSULE, LIQUID FILLED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80725-712-04EA - Each80725-71244333359-08da-44da-9a75-99002c5356d012024-01-04
80725-712-15EA - Each80725-712deb62e39-c7ae-4f9d-8ac5-b568b80f5e6412024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80725-712AVODART (DUTASTERIDE) CAPSULE, LIQUID FILLED [WAYLIS THERAPEUTICS LLC]4Current NDC, 2 package rows20250315_960797b3-09b1-4d6a-8ece-8b5d918e93e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352118Avodart 0.5 MG Oral CapsulePSN960797b3-09b1-4d6a-8ece-8b5d918e93e44
351172dutasteride 0.5 MG Oral CapsulePSN960797b3-09b1-4d6a-8ece-8b5d918e93e44
352118dutasteride 0.5 MG Oral Capsule [Avodart]SBD960797b3-09b1-4d6a-8ece-8b5d918e93e44
351172dutasteride 0.5 MG Oral CapsuleSCD960797b3-09b1-4d6a-8ece-8b5d918e93e44
352118Avodart 0.5 MG Oral CapsuleSY960797b3-09b1-4d6a-8ece-8b5d918e93e44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80725-712-048072507120490 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04) 2022-12-15NoNoHistorical
80725-712-158072507121530 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15) 2022-12-15NoNoHistorical