Felbamate (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72578-056-01

Felbamate tablets USP, 400 mg

100 Tablets

Rx only

Felbamate Tablets
(click image for full-size original)

NDC 72578-057-01

Felbamate tablets USP, 600 mg

100 Tablets

Rx only

Felbamate Tablets
(click image for full-size original)
FELBAMATE felbamate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELBAMATE (FELBAMATE) FELBAMATE 400 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
CELLULOSE, MICROCRYSTALLINE
FD&C RED NO. 40
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (OFF-WHITE TO PALE YELLOW COLOR) Score 2 pieces
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code 10;53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-056-06 30 TABLET in 1 BOTTLE None
2 NDC:72578-056-16 90 TABLET in 1 BOTTLE None
3 NDC:72578-056-01 100 TABLET in 1 BOTTLE None
4 NDC:72578-056-05 500 TABLET in 1 BOTTLE None
5 NDC:72578-056-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-056-30)
5 NDC:72578-056-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (72578-056-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208970 03/03/2020
FELBAMATE felbamate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELBAMATE (FELBAMATE) FELBAMATE 600 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
CELLULOSE, MICROCRYSTALLINE
D&C YELLOW NO. 10
FD&C RED NO. 40
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color PINK (LIGHT PINK TO PINK) Score 2 pieces
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code 10;54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-057-06 30 TABLET in 1 BOTTLE None
2 NDC:72578-057-16 90 TABLET in 1 BOTTLE None
3 NDC:72578-057-01 100 TABLET in 1 BOTTLE None
4 NDC:72578-057-05 500 TABLET in 1 BOTTLE None
5 NDC:72578-057-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-057-30)
5 NDC:72578-057-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (72578-057-77)
6 NDC:72578-057-28 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208970 03/03/2020
Labeler — Viona Pharmaceuticals Inc (081468959)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (72578-056), ANALYSIS (72578-057), MANUFACTURE (72578-056), MANUFACTURE (72578-057)

Revised: 10/2022 Viona Pharmaceuticals Inc

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