Prescription drug · ANDA
abiraterone acetate NDC 68462-882
Abiraterone acetate 500 mg/1 · Tablet · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-882-60 | 68462088260 | 60 TABLET in 1 BOTTLE (68462-882-60)Marketed from May 19, 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 acetate
- Generic name (nonproprietary)
- abiraterone acetate
- Active ingredients
- Abiraterone acetate — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209227
- 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 68462-882_ccb0d191-e233-4e8c-9485-044cbbdba4aaSPL ID ccb0d191-e233-4e8c-9485-044cbbdba4aaSPL set ID ba32c453-a231-452a-a6d9-b3e57afb2e75RxCUI 1100075, 1918042UNII EM5OCB9YJ6UPC 0368462882603
- 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
N468462088260followed by a unit qualifier and the quantityPackage 68462-0882-60. 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 209227
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 acetate | Abiraterone acetate 250 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-135 |
| abiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-110 |
| abiraterone acetate | Abiraterone acetate 500 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-111 |