NDC 57894-150

Zytiga

Abiraterone Acetate

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

• Product ID: 57894-150_020cef7a-8204-4534-b686-b29646c41eb3
• NDC: 57894-150
• Product Type: Human Prescription Drug
• Proprietary Name: Zytiga
• Generic Name: Abiraterone Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-04-28
• Marketing Category: NDA / NDA
• Application Number: NDA202379
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: ABIRATERONE ACETATE
• Active Ingredient Strength: 250 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 57894-150-12

120 TABLET in 1 BOTTLE (57894-150-12)

• Marketing Start Date: 2011-04-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-150-25 [57894015025]

Zytiga TABLET

• Marketing Category: NDA
• Application Number: NDA202379
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-01
• Marketing End Date: 2018-08-31

NDC 57894-150-12 [57894015012]

Zytiga TABLET

• Marketing Category: NDA
• Application Number: NDA202379
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-04-28

Drug Details

Active Ingredients

Ingredient	Strength
ABIRATERONE ACETATE	250 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]

Medicade Reported Pricing

57894015012 ZYTIGA 250 MG TABLET

Pricing Unit: EA | Drug Type:

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