NDC Code(s) : 72789-090-30, 72789-090-90
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SILODOSINSILODOSIN CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-090(NDC:72205-010)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILODOSIN(UNII: CUZ39LUY82)
(SILODOSIN - UNII:CUZ39LUY82) 		SILODOSIN8 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: MB5IUD6JUA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM ALUMINOMETASILICATE TYPE IA(UNII: 7LVU907546)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code S;8mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72789-090-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product23/06/2020
2NDC:72789-090-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product23/06/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210687 12/03/2018

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(72789-090)

PRINCIPAL DISPLAY PANEL

72789090 Label