NDC 59676-050

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 ID: 59676-050_11688298-6399-11ea-8a95-3feefb2ca371
• NDC: 59676-050
• Product Type: Human Prescription Drug
• Proprietary Name: BALVERSA
• Generic Name: Erdafitinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-12
• Marketing Category: NDA / NDA
• Application Number: NDA212018
• Labeler Name: Janssen Products LP
• Substance Name: ERDAFITINIB
• Active Ingredient Strength: 5 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59676-050-28

1 BOTTLE in 1 CARTON (59676-050-28) > 28 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2019-04-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-050-28 [59676005028]

BALVERSA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA212018
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-12

Drug Details

Active Ingredients

Ingredient	Strength
ERDAFITINIB	5 mg/1

OpenFDA Data

• SPL SET ID: 2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee
• Manufacturer:
  • Janssen Products LP
• UNII:
  • 890E37NHMV

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

NDC	Brand Name	Generic Name
59676-030	BALVERSA	Erdafitinib
59676-040	BALVERSA	Erdafitinib
59676-050	BALVERSA	Erdafitinib