NDC Code(s) : 50228-379-30, 50228-379-90, 50228-379-05, 50228-379-10
Packager : ScieGen Pharmaceuticals Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EzetimibeEzetimibe TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-379
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE(UNII: EOR26LQQ24)
(EZETIMIBE - UNII:EOR26LQQ24) 		EZETIMIBE10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (CAPSULE-SHAPED) Size 8 mm
Flavor Imprint Code SG;379
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-379-3030 in 1 BOTTLE Type 0: Not a Combination Product23/10/2020
2NDC:50228-379-9090 in 1 BOTTLE Type 0: Not a Combination Product23/10/2020
3NDC:50228-379-05500 in 1 BOTTLE Type 0: Not a Combination Product23/10/2020
4NDC:50228-379-101000 in 1 BOTTLE Type 0: Not a Combination Product23/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210673 10/23/2020

LABELER - ScieGen Pharmaceuticals Inc(079391286)

Establishment
Name Address ID/FEI Business Operations
ScieGen Pharmaceuticals Inc 079391286 analysis(50228-379), manufacture(50228-379)

PRINCIPAL DISPLAY PANEL

NDC 50228-379-30

Ezetimibe

Tablets, USP

10 mg

30 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

Ezetimibe-tabs-30s

NDC 50228-379-90

Ezetimibe

Tablets, USP

10 mg

90 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

Ezetimibe-tabs-30s

NDC 50228-379-05

Ezetimibe

Tablets, USP

10 mg

500 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

Ezetimibe-tabs-30s

NDC 50228-379-10

Ezetimibe

Tablets, USP

10 mg

1,000 Tablets Rx Only

ScieGen Pharmaceuticals, Inc.

Ezetimibe-tabs-30s