Felbamate (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Felbamate Oral Suspension, USP 600 mg/5 mL — 8 oz bottles (NDC 70954-051-10)

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Felbamate Oral Suspension, USP 600 mg/5 mL — 16 oz bottles (NDC 70954-051-20)

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FELBAMATE felbamate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-051
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
SORBITOL
CELLULOSE, MICROCRYSTALLINE
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
POLYSORBATE 80
DIMETHICONE
SACCHARIN SODIUM MONOHYDRATE
FD&C RED NO. 40
FD&C YELLOW NO. 6
WATER
SORBIC ACID
BENZOIC ACID
Product Characteristics
Color PINK Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70954-051-10 237 mL in 1 BOTTLE None
2 NDC:70954-051-20 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211333 07/15/2022
Labeler — Novitium Pharma LLC (080301870)
Establishment
Name Address ID/FEI Operations
Novitium Pharma LLC 080301870 ANALYSIS (70954-051), LABEL (70954-051), MANUFACTURE (70954-051), PACK (70954-051)

Revised: 09/2022 Novitium Pharma LLC

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