FDA.reportPublic FDA data

Dutasteride

Product NDC
51013-190
11-digit product format
510130190
Labeler code
51013
Product ID
51013-190_7d15e759-a3d5-49d4-b8a2-b8b588392a6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
ANDA209909
Marketing category
ANDA
Marketing start
2018-05-29
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51013-190-092025-01-30C16284748780-12cef2736-8ae7-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES . DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001
51013-190-302025-01-30C16284748780-12cef2736-8ae7-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES . DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-190-09Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED904
51013-190-30Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-190DUTASTERIDE CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]4Legacy NDC, 2 package rows20180530_047872d2-6621-4ff0-9bb8-88595bc7691f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSN047872d2-6621-4ff0-9bb8-88595bc7691f4
351172dutasteride 0.5 MG Oral CapsuleSCD047872d2-6621-4ff0-9bb8-88595bc7691f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51013-190-095101301900990 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-190-09) 2018-05-290000-00-00NoNoCurrent
51013-190-305101301903030 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-190-30) 2018-05-290000-00-00NoNoCurrent