SILODOSIN

Product NDC
72205-009
11-digit product format
722050009
Labeler code
72205
Product ID
72205-009_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
4 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
SILODOSIN4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCUZ39LUY82
Rxcui809477, 826612

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
089fe5d1-1a90-7a8e-a24a-107c84472400Product name420200507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-009-30SILODOSIN30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-009-30EA - Each72205-009df88fc90-4540-491f-bbf8-c30b262583f412019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-009SILODOSIN CAPSULE [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 1 package rows20210709_ee8d577e-948d-4164-9671-c876544ac83b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
72205-009-307220500093030 CAPSULE in 1 BOTTLE (72205-009-30) 30 capsule2018-12-030000-00-00NoNoCurrent