FDA.reportPublic FDA data

SILODOSIN

Product NDC
72789-090
11-digit product format
727890090
Labeler code
72789
Product ID
72789-090_4031d0db-272c-8e81-e063-6394a90a3b93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILODOSIN
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

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
72789-090-30SILODOSIN30 in 1 BOTTLE, PLASTICCAPSULE308
72789-090-90SILODOSIN90 in 1 BOTTLE, PLASTICCAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-090-30EA - Each72789-090366bd963-3b26-42a8-b4c6-9a8b6f26f00a12020-07-13
72789-090-90EA - Each72789-090a839c244-bf7a-42d0-a73c-50b80aabebe412020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-090SILODOSIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20241010_365a86b3-748a-465d-b489-dba1479be670.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-090-307278900903030 CAPSULE in 1 BOTTLE, PLASTIC (72789-090-30) 30 capsule2020-06-230000-00-00NoNoCurrent
72789-090-907278900909090 CAPSULE in 1 BOTTLE, PLASTIC (72789-090-90) 90 capsule2020-06-230000-00-00NoNoCurrent