Felbatol: Package Insert and Label Information (Page 5 of 5)

Package Label — Principal Display Panel – 100-count Bottle, 400 mg Tablet

NDC 0037-0430-01
100 Tablets
Felbatol®
(felbamate)
Tablets 400 mg
Rx Only
MEDA
Meda Pharmaceuticals®
Somerset, New Jersey 08873-4120
Usual Dosage: For full prescribing
information, see accompanying
package insert.
Store at controlled room temperature
20°-25°C (68°-77°F).
Dispense the accompanying
Medication Guide to each patient.
Dispense in a tight container.

Manufactured for:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

LB-024G5-10 Rev. 5/2018400934-01

Felbatol Tablets 400 mg Bottle Label
(click image for full-size original)

Package Label — Principal Display Panel – 100-count Bottle, 600 mg Tablet

NDC 0037-0431-01
100 Tablets
Felbatol®
(felbamate)
Tablets 600 mg
Rx Only
MEDA
Meda Pharmaceuticals®
Somerset, New Jersey 08873-4120

Usual Dosage: For full prescribing information,
see accompanying package insert.
Store at controlled room temperature 20°-25°C
(68°-77°F).
Dispense the accompanying Medication
Guide to each patient.
Dispense in a tight container.

Manufactured for:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

LB-024H5-10 Rev. 5/2018
400935-01

Felbatol Tablets 600 mg Bottle Label
(click image for full-size original)

Package Label — Principal Display Panel – 8 fl oz (237 mL) Bottle, 600 mg Suspension

NDC 0037-0442-67
8 fl oz (237 mL)
Felbatol®
(felbamate)
Oral Suspension
Each 5 mL contains
600 mg felbamate
Rx Only
SHAKE WELL
MEDA
PHARMACEUTICALS®
LB-024F5-11 140908-0218
Usual Dosage: For full prescribing information, see
accompanying package insert.
Store at controlled room temperature 20°-25°C (68°-77°F).
Dispense the accompanying Medication Guide to each
patient.
Dispense in a tight container.
Manufactured for:
Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120

Felbatol Oral Suspension 600 mg Bottle Label
(click image for full-size original)
FELBATOL felbamate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0037-0430
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELBAMATE (FELBAMATE) FELBAMATE 400 mg
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (capsule shaped) Size 16mm
Flavor Imprint Code 0430;FELBATOL;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0037-0430-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020189 07/29/1993
FELBATOL felbamate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0037-0431
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELBAMATE (FELBAMATE) FELBAMATE 600 mg
Product Characteristics
Color ORANGE (Peach) Score 2 pieces
Shape OVAL (capsule shaped) Size 19mm
Flavor Imprint Code 0431;FELBATOL;600
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0037-0431-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020189 07/29/1993
FELBATOL felbamate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0037-0442
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELBAMATE (FELBAMATE) FELBAMATE 600 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
FD&C RED NO. 40
WATER
SILICON DIOXIDE
DIMETHICONE
Product Characteristics
Color ORANGE (Peach) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0037-0442-67 237 mL in 1 BOTTLE, PLASTIC None
2 NDC:0037-0442-17 946 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020189 07/29/1993
Labeler — Meda Pharmaceuticals (051229602)

Revised: 11/2011 Meda Pharmaceuticals

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