FELBAMATE- felbamate tablet 
Zydus Lifesciences Limited

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Felbamate Tablets, USP

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1077-1

Felbamate tablets USP, 400 mg

100 Tablets

Rx only

labels

NDC 70771-1078-1

Felbamate tablets USP, 600 mg

100 Tablets

Rx only

labels
FELBAMATE 
felbamate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1077
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8) FELBAMATE400 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (OFF-WHITE TO PALE YELLOW COLOR) Score2 pieces
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 10;53
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1077-330 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
2NDC:70771-1077-990 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
3NDC:70771-1077-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
4NDC:70771-1077-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
5NDC:70771-1077-410 in 1 CARTON08/15/2017
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20897008/15/2017
FELBAMATE 
felbamate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1078
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8) FELBAMATE600 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINK (LIGHT PINK TO PINK) Score2 pieces
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 10;54
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1078-330 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
2NDC:70771-1078-990 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
3NDC:70771-1078-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
4NDC:70771-1078-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
5NDC:70771-1078-410 in 1 CARTON08/15/2017
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:70771-1078-8180 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20897008/15/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1077, 70771-1078) , MANUFACTURE(70771-1077, 70771-1078)

Revised: 10/2023
Document Id: 8ed3eb6a-7697-400c-ae6f-ff5387b71e0c
Set id: efa55cb2-b625-4392-9ddb-0a8ad8ee58c4
Version: 5
Effective Time: 20231004
 
Zydus Lifesciences Limited