Dutasteride

Product NDC
68071-2610
11-digit product format
680712610
Labeler code
68071
Product ID
68071-2610_d4c90e01-1c62-6865-e053-2995a90ae6dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206574
Marketing category
ANDA
Marketing start
2016-10-24
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2610-3Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2610DUTASTERIDE CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220105_d4c90e01-1c61-6865-e053-2995a90ae6dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSNd4c90e01-1c61-6865-e053-2995a90ae6dd1
351172dutasteride 0.5 MG Oral CapsuleSCDd4c90e01-1c61-6865-e053-2995a90ae6dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2610-36807126100330 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-2610-3) 2021-01-040000-00-00NoNoCurrent