Prescription drug · ANDA
Abiraterone Acetate (Abiraterone) NDC 60219-1165
Abiraterone acetate 250 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1165-7 | 6021911650760219116507 | 120 TABLET in 1 BOTTLE (60219-1165-7)Marketed from Apr 28, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Abiraterone acetate — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 60219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208327
- 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 60219-1165_1dfa3ed4-c682-4169-b39c-4415008774dcSPL ID 1dfa3ed4-c682-4169-b39c-4415008774dc
- 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
N460219116507followed by a unit qualifier and the quantityPackage 60219-1165-07. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60219-1165
- What is NDC 60219-1165?
- 60219-1165 is the product NDC for Abiraterone Acetate (abiraterone), Abiraterone acetate 250 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abiraterone Acetate (Abiraterone).
- What is the active ingredient?
- Abiraterone acetate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 60219. 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 500 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-1754 | 60219-1754-06 |
| Abiraterone acetate | Abiraterone acetate 500 mg/1 | Tablet, Film coatedOral | Florida Pharmaceutical Products, LLC | 71921-177 | 71921-0177-06 |
| 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 |
Other NDCs under ANDA 208327
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 |
|---|---|---|---|---|
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | AvKARE | 42291-024 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 500 mg/1 | TabletOral | AvKARE | 42291-073 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 500 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-1754 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | American Health Packaging | 60687-790 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 250 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1165 |
| Abiraterone Acetateabiraterone | Abiraterone acetate 500 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1754 |