FDA.reportPublic FDA data

Dutasteride

Product NDC
68071-4821
11-digit product format
680714821
Labeler code
68071
Product ID
68071-4821_1f974207-8715-912c-e063-6394a90abf17
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
Substance
DUTASTERIDE
Active strength
.5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dutasteride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DUTASTERIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0J6XJN02I
Rxcui351172

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
68071-4821-92024-06-14C16284748780-1ba0f9c33-4e74-a910-e053-dadaa90a0b85These 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
68071-4821-92023-01-30C16284748780-1ba0f9c33-4e74-a910-e053-dadaa90a0b85These 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
68071-4821-92021-02-17C16284748780-1ba0f9c33-4e74-a910-e053-dadaa90a0b85These 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
68071-4821-92021-01-29C16284748780-1ba0f9c33-4e74-a910-e053-dadaa90a0b85These 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
68071-4821-9Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4821DUTASTERIDE CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240815_85023ea5-af64-4b91-e053-2991aa0a3373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSN85023ea5-af64-4b91-e053-2991aa0a33734
351172dutasteride 0.5 MG Oral CapsuleSCD85023ea5-af64-4b91-e053-2991aa0a33734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4821-96807148210990 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-4821-9) 2019-03-260000-00-00NoNoCurrent