Prescription drug · ANDA
Abiraterone (abiraterone acetate) NDC 82249-010
Abiraterone acetate 250 mg/1 · Tablet · Oral · CivicaScript, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82249-010-12 | 82249001012 | 120 TABLET in 1 BOTTLE, PLASTIC (82249-010-12)Marketed from Jun 27, 2022 |
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
- Generic name (nonproprietary)
- abiraterone acetate
- Active ingredients
- Abiraterone acetate — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- CivicaScript, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208339
- 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 82249-010_e3758cee-2504-46be-8eb0-67463e7fe6edSPL ID e3758cee-2504-46be-8eb0-67463e7fe6edSPL set ID 0ef857ee-2bfc-4d27-a417-ad58fc3a6ff6RxCUI 1100075UNII EM5OCB9YJ6UPC 0382249010126
- 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
N482249001012followed by a unit qualifier and the quantityPackage 82249-0010-12. 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.
Other NDCs under ANDA 208339
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 |
|---|---|---|---|---|
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-213 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-9597 |
| Abirtegaabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral, Oral | CivicaScript, LLC | 82249-011 |