SILODOSIN

Product NDC
72789-351
11-digit product format
727890351
Labeler code
72789
Product ID
72789-351_40bb71ff-387e-bd53-e063-6394a90a38ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILODOSIN
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
Rxcui826612

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
72789-351-30SILODOSIN30 in 1 BOTTLE, PLASTICCAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-351-30EA - Each72789-351cf479cc6-a878-4c33-8946-69f2d273d12112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-351SILODOSIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7Current NDC, 1 package rows20240802_94bca72c-c74a-4181-8b6a-a0a2f654a0a7.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-351-307278903513030 CAPSULE in 1 BOTTLE, PLASTIC (72789-351-30) 30 capsule2023-09-22NoNoCurrent