Silodosin

Product NDC
60219-1420
11-digit product format
602191420
Labeler code
60219
Product ID
60219-1420_39f09c3f-1ddd-44fb-a71e-18d9a9486654
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silodosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209745
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
60219-1420-3Silodosin30 in 1 BOTTLECAPSULE302
60219-1420-9Silodosin90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1420SILODOSIN CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]2Current NDC, Legacy NDC, 2 package rows20231229_455c98be-aa01-4393-915f-34d1859005c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826612silodosin 4 MG Oral CapsulePSN455c98be-aa01-4393-915f-34d1859005c02
809477silodosin 8 MG Oral CapsulePSN455c98be-aa01-4393-915f-34d1859005c02
826612silodosin 4 MG Oral CapsuleSCD455c98be-aa01-4393-915f-34d1859005c02
809477silodosin 8 MG Oral CapsuleSCD455c98be-aa01-4393-915f-34d1859005c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-1420-36021914200330 CAPSULE in 1 BOTTLE (60219-1420-3) 30 capsule2018-12-030000-00-00NoNoCurrent
60219-1420-96021914200990 CAPSULE in 1 BOTTLE (60219-1420-9) 90 capsule2018-12-030000-00-00NoNoCurrent