Felbamate (Page 9 of 9)

PRINCIPAL DISPLAY PANEL – 400 mg Tablet

Rx Only

NDC 51525-0430-1
100 Tablets


Felbamate
Tablets USP, 400 mg

Wallace Pharmaceuticals™


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:
Wallace Pharmaceuticals, Inc.
Somerset, NJ 08873-4120

LB-032010-04 Rev. 5/2018400936-01

Felbamate Oral Suspension 400 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 600 mg Tablet

NDC 51525-0431-1
Rx Only

100 Tablets

Felbamate
Tablets USP, 600 mg

Wallace Pharmaceuticals™


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:
Wallace Pharmaceuticals, Inc.
Somerset, NJ 08873-4120

LB-032110-04 Rev. 5/2018400937-01

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

PRINCIPAL DISPLAY PANEL – 600 mg Oral Suspension

NDC 51525-0442-8


8 fl oz (237 mL)

Felbamate
Oral Suspension, USP

Each 5 mL contains
600 mg felbamate

Rx Only
SHAKE WELL

LB-033608-04 141233-0821

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:
Wallace Pharmaceuticals Inc. Somerset, NJ 08873-4120 U.S.A.

Felbamate Oral Suspension 8 fl oz Label
(click image for full-size original)
FELBAMATE felbamate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51525-0430
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 WP;0320
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51525-0430-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020189 11/11/2011
FELBAMATE felbamate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51525-0431
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 WP;0321
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51525-0431-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020189 11/11/2011
FELBAMATE felbamate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51525-0442
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELBAMATE (FELBAMATE) FELBAMATE 600 mg in 5 mL
Product Characteristics
Color ORANGE (Peach) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51525-0442-8 237 mL in 1 BOTTLE None
2 NDC:51525-0442-3 946 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020189 11/23/2011
Labeler — Wallace Pharmaceuticals Inc. (962531955)

Revised: 02/2018 Wallace Pharmaceuticals Inc.

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