FDA.reportPublic FDA data

SILODOSIN

Product NDC
59651-095
11-digit product format
596510095
Labeler code
59651
Product ID
59651-095_ba067fa8-8f09-40fb-be9d-a9ff2b0fd72d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILODOSIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA210626
Marketing category
ANDA
Marketing start
2018-12-10
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
59651-095-30SILODOSIN30 in 1 BOTTLECAPSULE306
59651-095-90SILODOSIN90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-095-30EA - Each59651-095ff26ea8d-177d-4bea-a036-061d68c26ca012019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-095SILODOSIN CAPSULE [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 2 package rows20240509_5e5038ea-9214-469b-8174-e5787be7a801.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826612silodosin 4 MG Oral CapsulePSN94bca72c-c74a-4181-8b6a-a0a2f654a0a78
826612silodosin 4 MG Oral CapsuleSCD94bca72c-c74a-4181-8b6a-a0a2f654a0a78
826612silodosin 4 MG Oral CapsulePSN5e5038ea-9214-469b-8174-e5787be7a8016
809477silodosin 8 MG Oral CapsulePSN5e5038ea-9214-469b-8174-e5787be7a8016
826612silodosin 4 MG Oral CapsuleSCD5e5038ea-9214-469b-8174-e5787be7a8016
809477silodosin 8 MG Oral CapsuleSCD5e5038ea-9214-469b-8174-e5787be7a8016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-095-305965100953030 CAPSULE in 1 BOTTLE (59651-095-30) 30 capsule2018-12-100000-00-00NoNoCurrent
59651-095-905965100959090 CAPSULE in 1 BOTTLE (59651-095-90) 90 capsule2018-12-100000-00-00NoNoCurrent