FDA.reportPublic FDA data

Silodosin

Product NDC
46708-406
11-digit product format
467080406
Labeler code
46708
Product ID
46708-406_74147395-217c-4a7c-8acf-92a95ca7b7d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silodosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA211731
Marketing category
ANDA
Marketing start
2019-11-25
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
089fe5d1-1a90-7a8e-a24a-107c84472400Product name420200507

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-406-302023-02-01C16284748780-1f386c649-dc21-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-406-902023-02-01C16284748780-1f386c649-dc21-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-406-912023-02-01C16284748780-1f386c649-dc21-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-406-302023-01-30C16284748780-1f386c649-dc21-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-406-902023-01-30C16284748780-1f386c649-dc21-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-406-912023-01-30C16284748780-1f386c649-dc21-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-406-30Silodosin30 in 1 BOTTLECAPSULE302
46708-406-90Silodosin90 in 1 BOTTLECAPSULE902
46708-406-91Silodosin1000 in 1 BOTTLECAPSULE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-406SILODOSIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 3 package rows20230202_322ce16e-485f-4fd2-bb30-6b4776bc9e85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826612silodosin 4 MG Oral CapsulePSN322ce16e-485f-4fd2-bb30-6b4776bc9e852
809477silodosin 8 MG Oral CapsulePSN322ce16e-485f-4fd2-bb30-6b4776bc9e852
826612silodosin 4 MG Oral CapsuleSCD322ce16e-485f-4fd2-bb30-6b4776bc9e852
809477silodosin 8 MG Oral CapsuleSCD322ce16e-485f-4fd2-bb30-6b4776bc9e852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-406-304670804063030 CAPSULE in 1 BOTTLE (46708-406-30) 30 capsule2019-11-250000-00-00NoNoCurrent
46708-406-904670804069090 CAPSULE in 1 BOTTLE (46708-406-90) 90 capsule2019-11-250000-00-00NoNoCurrent
46708-406-91467080406911000 CAPSULE in 1 BOTTLE (46708-406-91) 1000 capsule2019-11-250000-00-00NoNoCurrent