BALVERSA (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 3 mg Tablet Bottle Carton

NDC 59676-030-56

Balversa®
(erdafitinib) tablets

3 mg

Each film-coated tabletcontains 3 mg of erdafitinib.

Rx only

56 film-coated tablets

PRINCIPAL DISPLAY PANEL -- 3 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4 mg Tablet Bottle Carton

NDC 59676-040-56

Balversa®
(erdafitinib) tablets

4 mg

Each film-coated tabletcontains 4 mg of erdafitinib.

Rx only

56 film-coated tablets

PRINCIPAL DISPLAY PANEL -- 4 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mg Tablet Bottle Carton

NDC 59676-050-28

Balversa®
(erdafitinib) tablets

5 mg

Each film-coated tabletcontains 5 mg of erdafitinib.

Rx only

28 film-coated tablets

PRINCIPAL DISPLAY PANEL -- 5 mg Tablet Bottle Carton
(click image for full-size original)
BALVERSA erdafitinib 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 (Erdafitinib) Erdafitinib 3 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose sodium
Magnesium stearate
Mannitol
Meglumine
Microcrystalline Cellulose
GLYCERYL MONOCAPRYLOCAPRATE
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL (biconvex shaped) Size 8mm
Flavor Imprint Code 3;EF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-030-56 1 BOTTLE in 1 CARTON contains a BOTTLE
1 56 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (59676-030-56)
2 NDC:59676-030-84 1 BOTTLE in 1 CARTON contains a BOTTLE
2 84 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (59676-030-84)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212018 04/12/2019
BALVERSA erdafitinib 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 (Erdafitinib) Erdafitinib 4 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose sodium
Magnesium stearate
Mannitol
Meglumine
Microcrystalline Cellulose
GLYCERYL MONOCAPRYLOCAPRATE
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color ORANGE Score no score
Shape OVAL (biconvex shaped) Size 8mm
Flavor Imprint Code 4;EF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-040-28 1 BOTTLE in 1 CARTON contains a BOTTLE
1 28 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (59676-040-28)
2 NDC:59676-040-56 1 BOTTLE in 1 CARTON contains a BOTTLE
2 56 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (59676-040-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212018 04/12/2019
BALVERSA erdafitinib 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 (Erdafitinib) Erdafitinib 5 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose sodium
Magnesium stearate
Mannitol
Meglumine
Microcrystalline Cellulose
GLYCERYL MONOCAPRYLOCAPRATE
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color BROWN Score no score
Shape OVAL (biconvex shaped) Size 9mm
Flavor Imprint Code 5;EF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-050-28 1 BOTTLE in 1 CARTON contains a BOTTLE
1 28 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (59676-050-28)
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 Operations
Cilag AG 483237103 API MANUFACTURE (59676-030), API MANUFACTURE (59676-040), API MANUFACTURE (59676-050)
Establishment
Name Address ID/FEI Operations
Johnson & Johnson Private Limited 677603030 ANALYSIS (59676-030), ANALYSIS (59676-040), ANALYSIS (59676-050)
Establishment
Name Address ID/FEI Operations
Janssen Cilag SpA 542797928 MANUFACTURE (59676-030), MANUFACTURE (59676-040), MANUFACTURE (59676-050), ANALYSIS (59676-030), ANALYSIS (59676-040), ANALYSIS (59676-050), PACK (59676-030), PACK (59676-040), PACK (59676-050)
Establishment
Name Address ID/FEI Operations
AndersonBrecon Inc. 053217022 PACK (59676-030), PACK (59676-040), PACK (59676-050)

Revised: 07/2020 Janssen Products LP

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