Felbamate

FELBAMATE — felbamate tablet
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1077-1

Felbamate tablets USP, 400 mg

100 Tablets

Rx only

labels
(click image for full-size original)

NDC 70771-1078-1

Felbamate tablets USP, 600 mg

100 Tablets

Rx only

labels
(click image for full-size original)
FELBAMATE
felbamate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1077
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:70771-1077-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1077-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1077-1 100 TABLET in 1 BOTTLE None
4 NDC:70771-1077-5 500 TABLET in 1 BOTTLE None
5 NDC:70771-1077-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1077-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208970 08/15/2017
FELBAMATE
felbamate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1078
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:70771-1078-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1078-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1078-1 100 TABLET in 1 BOTTLE None
4 NDC:70771-1078-5 500 TABLET in 1 BOTTLE None
5 NDC:70771-1078-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1078-4)
6 NDC:70771-1078-8 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208970 08/15/2017
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1077), ANALYSIS (70771-1078), MANUFACTURE (70771-1077), MANUFACTURE (70771-1078)

Revised: 11/2022 Zydus Lifesciences Limited

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