Felbamate

FELBAMATE- felbamate tablet
Cadila Healthcare 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 — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1077), ANALYSIS (70771-1078), MANUFACTURE (70771-1077), MANUFACTURE (70771-1078)

Revised: 07/2020 Cadila Healthcare Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.