NDC 59676-040

BALVERSA

Erdafitinib

BALVERSA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Products Lp. The primary component is Erdafitinib.

Product ID59676-040_11688298-6399-11ea-8a95-3feefb2ca371
NDC59676-040
Product TypeHuman Prescription Drug
Proprietary NameBALVERSA
Generic NameErdafitinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-12
Marketing CategoryNDA / NDA
Application NumberNDA212018
Labeler NameJanssen Products LP
Substance NameERDAFITINIB
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59676-040-28

1 BOTTLE in 1 CARTON (59676-040-28) > 28 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2019-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59676-040-56 [59676004056]

BALVERSA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA212018
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-12

NDC 59676-040-28 [59676004028]

BALVERSA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA212018
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-12

Drug Details

Active Ingredients

IngredientStrength
ERDAFITINIB4 mg/1

OpenFDA Data

SPL SET ID:2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee
Manufacturer
UNII

NDC Crossover Matching brand name "BALVERSA" or generic name "Erdafitinib"

NDCBrand NameGeneric Name
59676-030BALVERSAErdafitinib
59676-040BALVERSAErdafitinib
59676-050BALVERSAErdafitinib

Trademark Results [BALVERSA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BALVERSA
BALVERSA
87362785 5794954 Live/Registered
Johnson & Johnson
2017-03-08

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