Zytiga
- Product NDC
- 57894-150
- 11-digit product format
- 578940150
- Labeler code
- 57894
- Product ID
- 57894-150_316974bf-2b6d-9d66-e063-6294a90a33a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abiraterone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Janssen Biotech, Inc.
- Application
- NDA202379
- Marketing category
- NDA
- Marketing start
- 2011-04-28
- Substance
- ABIRATERONE ACETATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zytiga
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ABIRATERONE ACETATE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EM5OCB9YJ6 |
| Rxcui | 1100075, 1100079, 1918042, 1918044 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-150-12 | Zytiga | 120 in 1 BOTTLE | TABLET | 120 | | 40 |
| 57894-150-25 | Zytiga | 120 in 1 BOTTLE | TABLET | 120 | | 40 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| abiraterone acetate | ACTIVE INGREDIENT | EM5OCB9YJ6 | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
| abiraterone | ACTIVE MOIETY | G819A456D0 | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57894-150 | ZYTIGA (ABIRATERONE ACETATE) TABLET ZYTIGA (ABIRATERONE ACETATE) TABLET, FILM COATED [JANSSEN BIOTECH, INC.] | 40 | Current NDC, Legacy NDC, 2 package rows | 20250331_4e338e89-3cf2-48eb-b6e2-a06c608c6513.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57894-150-12 | 57894015012 | 120 TABLET in 1 BOTTLE (57894-150-12) | 120 tablet | 2011-04-28 | 0000-00-00 | No | No | Current |
| 57894-150-25 | 57894015025 | 120 in 1 BOTTLE | | | | | | Historical |