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 |
Marketing Start Date | 2017-04-17 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA202379 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-04-17 |
Marketing Category | NDA |
Application Number | NDA202379 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-04-17 |
Ingredient | Strength |
---|---|
ABIRATERONE ACETATE | 500 mg/1 |
SPL SET ID: | 4e338e89-3cf2-48eb-b6e2-a06c608c6513 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZYTIGA 85096902 4036085 Live/Registered |
JOHNSON & JOHNSON 2010-07-30 |