Prescription drug · ANDA
Abiraterone acetate NDC 71921-177
Abiraterone acetate 500 mg/1 · Tablet, Film coated · Oral · Florida Pharmaceutical Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71921-177-06 | 7192101770671921017706 | 60 TABLET, FILM COATED in 1 BOTTLE (71921-177-06)Marketed from Apr 10, 2023 |
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)
- Abiraterone acetate
- Generic name (nonproprietary)
- abiraterone acetate
- Active ingredients
- Abiraterone acetate — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Florida Pharmaceutical Products, LLCNDC labeler code 71921
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215086
- 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 71921-177_2b8d3621-3b8b-286c-e063-6294a90a7ac2SPL ID 2b8d3621-3b8b-286c-e063-6294a90a7ac2SPL set ID 68121a71-5024-4f9e-bd9c-2d412f6a6355RxCUI 1918042UNII EM5OCB9YJ6UPC 0371921177066
- 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
N471921017706followed by a unit qualifier and the quantityPackage 71921-0177-06. 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)
Abiraterone acetate tablets are 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) Abiraterone acetate tablets are 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 71921-177
- What is NDC 71921-177?
- 71921-177 is the product NDC for Abiraterone acetate, Abiraterone acetate 500 mg/1 tablet, film coated, listed with the FDA by Florida Pharmaceutical Products, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abiraterone acetate.
- What is the active ingredient?
- Abiraterone acetate.
- Who is the labeler?
- Florida Pharmaceutical Products, LLC, NDC labeler code 71921. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Abiraterone acetate?
- 28 other product NDCs are listed under this name. See all Abiraterone acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Abiraterone acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Abiraterone Acetate | Abiraterone acetate 250 mg/1 | TabletOral | AvPAK | 50268-032 | 50268-0032-12 |
| Abiraterone Acetate | Abiraterone acetate 250 mg/1 | TabletOral | Dr. Reddys Laboratories Inc | 75907-224 | 75907-0224-04 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | American Health Packaging | 60687-790 | 60687-0790-21 |
| Abiraterone Acetate | Abiraterone acetate 500 mg/1 | TabletOral | Dr. Reddys Laboratories Inc | 43598-468 | 43598-0468-3843598-0468-60 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-1165 | 60219-1165-07 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 500 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-1754 | 60219-1754-06 |
| abiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC. | 71921-178 | 71921-0178-20 |
| abiraterone acetate | Abiraterone acetate 500 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-882 | 68462-0882-60 |
| abiraterone acetate | Abiraterone acetate 500 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-111 | 72603-0111-01 |
| abiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-110 | 72603-0110-01 |