AVODART

Product NDC
69784-712
11-digit product format
697840712
Labeler code
69784
Product ID
69784-712_510e9349-3851-4e2a-988b-1c10462fb8c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Woodward Pharma Services LLC
Application
NDA021319
Marketing category
NDA
Marketing start
2022-12-15
Marketing end
0000-00-00
Substance
DUTASTERIDE
Active strength
1 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-712-04EA - Each69784-71281e96ef9-f874-4934-88c0-491b84f037d712023-01-09
69784-712-15EA - Each69784-7123fd17989-0dd9-4235-ad7e-bd26707e612412023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-712AVODART (DUTASTERIDE) CAPSULE, LIQUID FILLED [WOODWARD PHARMA SERVICES LLC]1Legacy NDC20221220_4cad5edd-1f9b-4537-8506-24d93fe935ae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69784-712-046978407120490 CAPSULE, LIQUID FILLED in 1 BOTTLE (69784-712-04) 2022-12-150000-00-00NoNoCurrent
69784-712-156978407121530 CAPSULE, LIQUID FILLED in 1 BOTTLE (69784-712-15) 2022-12-150000-00-00NoNoCurrent