NDC Code(s) : 69539-052-30, 69539-052-90, 69539-052-99, 69539-053-30, 69539-053-90, 69539-053-99
Packager : MSN LABORATORIES PRIVATE LIMITED

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SILODOSIN SILODOSIN CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:69539-052
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILODOSIN(UNII: CUZ39LUY82)
(SILODOSIN - UNII:CUZ39LUY82) 		SILODOSIN4 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 15 mm
Flavor Imprint Code S;4mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69539-052-3030 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
2NDC:69539-052-9090 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
3NDC:69539-052-991000 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210687 12/03/2018
SILODOSIN SILODOSIN CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:69539-053
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:69539-053-3030 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
2NDC:69539-053-9090 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
3NDC:69539-053-991000 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210687 12/03/2018

LABELER - MSN LABORATORIES PRIVATE LIMITED(650786952)

Establishment
Name Address ID/FEI Business Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS(69539-052, 69539-053), MANUFACTURE(69539-052, 69539-053)

PRINCIPAL DISPLAY PANEL

4mg-container-label-30s-count

4mg-30s

4mg-container-label-90s-count

4mg-30s

4mg-container-label-1000s-count

4mg-30s

8mg-container-label-30s-count

4mg-30s

8mg-container-label-90s-count

4mg-30s

8mg-container-label-1000s-count

4mg-30s