FDA.reportPublic FDA data

Dutasteride

Product NDC
62112-8068
11-digit product format
621128068
Labeler code
62112
Product ID
62112-8068_2f4a4ce5-53b2-7457-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Intergel Pharmaceuticals Inc
Application
ANDA206373
Marketing category
ANDA
Marketing start
2002-12-10
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
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62112-8068-12021-07-23C16284748780-1c7ccaba7-1245-fd44-e053-dadaa90aa01bThese 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
62112-8068-22021-07-23C16284748780-1c7ccaba7-1245-fd44-e053-dadaa90aa01bThese 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
62112-8068-1Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED304
62112-8068-2Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62112-8068DUTASTERIDE CAPSULE, LIQUID FILLED [INTERGEL PHARMACEUTICALS INC]4Legacy NDC, 2 package rows20160423_35f16489-00d7-0f8b-3cd6-2abbe277af19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSN35f16489-00d7-0f8b-3cd6-2abbe277af194
351172dutasteride 0.5 MG Oral CapsuleSCD35f16489-00d7-0f8b-3cd6-2abbe277af194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62112-8068-16211280680130 CAPSULE, LIQUID FILLED in 1 BOTTLE (62112-8068-1) 2002-12-100000-00-00NoNoCurrent
62112-8068-26211280680290 CAPSULE, LIQUID FILLED in 1 BOTTLE (62112-8068-2) 2002-12-100000-00-00NoNoCurrent