FDA.reportPublic FDA data

Dutasteride

Product NDC
0115-1438
11-digit product format
001151438
Labeler code
0115
Product ID
0115-1438_67c28dc0-a367-4177-af7d-731eba4ce8f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Impax Generics
Application
ANDA200899
Marketing category
ANDA
Marketing start
2015-11-20
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
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1438-082020-01-31C16284748780-19d75b9d0-26a4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE CAPSULES, oral Initial U.S. Approval: 2001
0115-1438-102020-01-31C16284748780-19d75b9d0-26a4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE CAPSULES, oral Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1438-08Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED3017
0115-1438-10Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1438-08EA - Each0115-14380f1fdb8a-8828-4513-a993-6f61f67cae0012016-01-13
0115-1438-10EA - Each0115-1438e75ecc6a-5841-4c93-8ee3-523c6954501a12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1438DUTASTERIDE CAPSULE, LIQUID FILLED [IMPAX GENERICS]17Legacy NDC, 2 package rows20151203_a63dc429-cbcd-44ba-a87a-96ab623ab0e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSNa63dc429-cbcd-44ba-a87a-96ab623ab0e017
351172dutasteride 0.5 MG Oral CapsuleSCDa63dc429-cbcd-44ba-a87a-96ab623ab0e017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0115-1438-080011514380830 in 1 BOTTLEHistorical
0115-1438-100011514381090 in 1 BOTTLEHistorical