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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
CUZ39LUY82SILODOSIN160970-54-7SILODOSIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-351-307278903513030 CAPSULE in 1 BOTTLE, PLASTIC (72789-351-30) 30 capsule2023-09-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SILODOSINPD-Rx Pharmaceuticals, Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL8
SILODOSINPD-Rx Pharmaceuticals, Inc.2024-07-31HUMAN PRESCRIPTION DRUG LABEL7