NDC 57894-195

Zytiga

Abiraterone Acetate

Zytiga is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Abiraterone Acetate.

• Product ID: 57894-195_020cef7a-8204-4534-b686-b29646c41eb3
• NDC: 57894-195
• Product Type: Human Prescription Drug
• Proprietary Name: Zytiga
• Generic Name: Abiraterone Acetate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-04-17
• Marketing Category: NDA / NDA
• Application Number: NDA202379
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: ABIRATERONE ACETATE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 57894-195-06

60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06)

• Marketing Start Date: 2017-04-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-195-15 [57894019515]

Zytiga TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202379
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-04-17

NDC 57894-195-06 [57894019506]

Zytiga TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202379
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-17

Drug Details

Active Ingredients

Ingredient	Strength
ABIRATERONE ACETATE	500 mg/1

OpenFDA Data

• SPL SET ID: 4e338e89-3cf2-48eb-b6e2-a06c608c6513
• Manufacturer:
  • Janssen Biotech, Inc.
• UNII:
  • EM5OCB9YJ6
• RxNorm Concept Unique ID - RxCUI:
  • 1918044
  • 1100079
  • 1100075
  • 1918042

Pharmacological Class

• Cytochrome P450 17A1 Inhibitors [MoA]
• Cytochrome P450 17A1 Inhibitor [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]

NDC Crossover Matching brand name "Zytiga" or generic name "Abiraterone Acetate"

NDC	Brand Name	Generic Name
57894-195	Zytiga	Zytiga
57894-150	Zytiga	Zytiga
0143-9597	Abiraterone	Abiraterone acetate
0093-1125	Abiraterone Acetate	Abiraterone Acetate
0378-6920	Abiraterone Acetate	abiraterone acetate
0378-6921	Abiraterone Acetate	abiraterone acetate
0378-6924	Abiraterone Acetate	abiraterone acetate
0904-6948	Abiraterone Acetate	Abiraterone Acetate
16714-963	Abiraterone Acetate	Abiraterone Acetate
42292-057	Abiraterone Acetate	abiraterone acetate
43598-358	Abiraterone Acetate	Abiraterone Acetate
47335-401	YONSA	abiraterone acetate