Prescription drug · ANDA
Abiraterone (Abiraterone acetate) NDC 0143-9597
Abiraterone acetate 250 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9597-21 | 0014395972100143959721 | 120 TABLET in 1 BOTTLE (0143-9597-21)Marketed from Nov 23, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- 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 0143-9597_35e5846f-9299-4190-94bb-6b0bb0d92485SPL ID 35e5846f-9299-4190-94bb-6b0bb0d92485SPL set ID be29365a-ed25-44c0-9818-e9016dc95ba6RxCUI 1100075UNII EM5OCB9YJ6UPC 0301439597216
- 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
N400143959721followed by a unit qualifier and the quantityPackage 00143-9597-21. 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 0143-9597
- What is NDC 0143-9597?
- 0143-9597 is the product NDC for Abiraterone (abiraterone acetate), Abiraterone acetate 250 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abiraterone (Abiraterone acetate).
- What is the active ingredient?
- Abiraterone acetate.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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?
- 9 other product NDCs are listed under this name. See all Abiraterone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Abiraterone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Abirateroneabiraterone acetate | Abiraterone acetate 500 mg/1 | TabletOral | BluePoint Laboratories | 68001-673 | 68001-0673-06 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-284 | 72205-0284-0572205-0284-92 |
| Abirateroneabiraterone acetate | Abiraterone acetate 500 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-285 | 72205-0285-0572205-0285-60 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-139 | 82009-0139-12 |
| Abirateroneabiraterone acetate | Abiraterone acetate 500 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-140 | 82009-0140-60 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | BluePoint Laboratories | 68001-489 | 68001-0489-07 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-030 | 72205-0030-92 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-213 | 72789-0213-98 |
| Abirateroneabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral | CivicaScript, LLC | 82249-010 | 82249-0010-12 |
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 | CivicaScript, LLC | 82249-010 |
| Abirtegaabiraterone acetate | Abiraterone acetate 250 mg/1 | TabletOral, Oral | CivicaScript, LLC | 82249-011 |