NDC Code(s) : 59676-030-56, 59676-030-84, 59676-040-28, 59676-040-56, 59676-050-28
Packager : Janssen Products LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BALVERSAErdafitinib TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-030
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERDAFITINIB(UNII: 890E37NHMV)
(ERDAFITINIB - UNII:890E37NHMV) 		ERDAFITINIB3 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
GLYCERYL MONOCAPRYLOCAPRATE(UNII: G7515SW10N)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape OVAL (biconvex shaped) Size 8 mm
Flavor Imprint Code 3;EF
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59676-030-561 in 1 CARTON 04/12/2019
156 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:59676-030-841 in 1 CARTON 04/12/2019
284 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212018 04/12/2019
BALVERSAErdafitinib TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-040
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERDAFITINIB(UNII: 890E37NHMV)
(ERDAFITINIB - UNII:890E37NHMV) 		ERDAFITINIB4 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
GLYCERYL MONOCAPRYLOCAPRATE(UNII: G7515SW10N)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color orange Score no score
Shape OVAL (biconvex shaped) Size 8 mm
Flavor Imprint Code 4;EF
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59676-040-281 in 1 CARTON 04/12/2019
128 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:59676-040-561 in 1 CARTON 04/12/2019
256 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212018 04/12/2019
BALVERSAErdafitinib TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-050
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERDAFITINIB(UNII: 890E37NHMV)
(ERDAFITINIB - UNII:890E37NHMV) 		ERDAFITINIB5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
GLYCERYL MONOCAPRYLOCAPRATE(UNII: G7515SW10N)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color brown Score no score
Shape OVAL (biconvex shaped) Size 9 mm
Flavor Imprint Code 5;EF
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59676-050-281 in 1 CARTON 04/12/2019
128 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212018 04/12/2019

LABELER - Janssen Products LP(804684207)

Establishment
Name Address ID/FEI Business Operations
Cilag AG 483237103 api manufacture(59676-030, 59676-040, 59676-050)

Establishment
Name Address ID/FEI Business Operations
Johnson & Johnson Private Limited 677603030 analysis(59676-030, 59676-040, 59676-050)

Establishment
Name Address ID/FEI Business Operations
Janssen Cilag SpA 542797928 manufacture(59676-030, 59676-040, 59676-050), analysis(59676-030, 59676-040, 59676-050), pack(59676-030, 59676-040, 59676-050)

PRINCIPAL DISPLAY PANEL

3 mg Tablet Bottle CartonNDC 59676-030-56

Balversa ®
(erdafitinib) tablets

3 mg

Each film-coated tablet
contains 3 mg of erdafitinib.

Rx only

56 film-coated tablets

PRINCIPAL DISPLAY PANEL

4 mg Tablet Bottle CartonNDC 59676-040-56

Balversa ®
(erdafitinib) tablets

4 mg

Each film-coated tablet
contains 4 mg of erdafitinib.

Rx only

56 film-coated tablets

PRINCIPAL DISPLAY PANEL

5 mg Tablet Bottle CartonNDC 59676-050-28

Balversa ®
(erdafitinib) tablets

5 mg

Each film-coated tablet
contains 5 mg of erdafitinib.

Rx only

28 film-coated tablets