FDA.reportPublic FDA data

SILODOSIN

Product NDC
72205-010
11-digit product format
722050010
Labeler code
72205
Product ID
72205-010_3f84ebe8-9db0-4334-984d-1bb4996c4339
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILODOSIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA210687
Marketing category
ANDA
Marketing start
2018-12-03
Substance
SILODOSIN
Active strength
8 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILODOSIN8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCUZ39LUY82
Rxcui809477, 826612

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
089fe5d1-1a90-7a8e-a24a-107c84472400Product name420200507
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-010-30SILODOSIN30 in 1 BOTTLECAPSULE302
72205-010-90SILODOSIN90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-010-30EA - Each72205-0103e0d742b-ee70-4cc1-82d1-dc5e76b6e70012019-01-24
72205-010-90EA - Each72205-010563fec11-6c0a-4e99-9745-69563028fb4912019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-010SILODOSIN CAPSULE [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20210709_ee8d577e-948d-4164-9671-c876544ac83b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809477silodosin 8 MG Oral CapsulePSN365a86b3-748a-465d-b489-dba1479be6708
809477silodosin 8 MG Oral CapsuleSCD365a86b3-748a-465d-b489-dba1479be6708
826612silodosin 4 MG Oral CapsulePSNee8d577e-948d-4164-9671-c876544ac83b2
809477silodosin 8 MG Oral CapsulePSNee8d577e-948d-4164-9671-c876544ac83b2
826612silodosin 4 MG Oral CapsuleSCDee8d577e-948d-4164-9671-c876544ac83b2
809477silodosin 8 MG Oral CapsuleSCDee8d577e-948d-4164-9671-c876544ac83b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-010-307220500103030 CAPSULE in 1 BOTTLE (72205-010-30) 30 capsule2018-12-030000-00-00NoNoCurrent
72205-010-907220500109090 CAPSULE in 1 BOTTLE (72205-010-90) 90 capsule2018-12-030000-00-00NoNoCurrent