Prescription drug · NDA
Zytiga (Abiraterone acetate) NDC 57894-195
Abiraterone acetate 500 mg/1 · Tablet, Film coated · Oral · Janssen Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-195-06 | 5789401950657894019506 | 60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06)Marketed from Apr 17, 2017 | |
| 57894-195-15 | 5789401951557894019515 | 60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15)Marketed from Apr 17, 2017 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zytiga
- Generic name (nonproprietary)
- abiraterone acetate
- Active ingredients
- Abiraterone acetate — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Janssen Biotech, Inc.NDC labeler code 57894
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202379
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)
- Identifiers
- Product ID 57894-195_316974bf-2b6d-9d66-e063-6294a90a33a9SPL ID 316974bf-2b6d-9d66-e063-6294a90a33a9SPL set ID 4e338e89-3cf2-48eb-b6e2-a06c608c6513RxCUI 1100075, 1100079, 1918042, 1918044UNII EM5OCB9YJ6UPC 0357894195061, 0357894150121
- Pharmacologic class
- Cytochrome P450 17A1 Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N457894019506followed by a unit qualifier and the quantityPackage 57894-0195-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 57894-195
- What is NDC 57894-195?
- 57894-195 is the product NDC for Zytiga (abiraterone acetate), Abiraterone acetate 500 mg/1 tablet, film coated, listed with the FDA by Janssen Biotech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zytiga (Abiraterone acetate).
- What is the active ingredient?
- Abiraterone acetate.
- Who is the labeler?
- Janssen Biotech, Inc., NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zytiga?
- 1 other product NDC are listed under this name. See all Zytiga NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zytiga products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zytigaabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | Janssen Biotech, Inc. | 57894-150 | 57894-0150-12 |
Other NDCs under NDA 202379
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zytigaabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | Janssen Biotech, Inc. | 57894-150 |