abiraterone acetate NDC 60505-4764

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-4764Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-4764Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
60505-4764-6	60505476406	60 TABLET, FILM COATED in 1 BOTTLE (60505-4764-6)Marketed from Jul 16, 2021

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 acetate
Active ingredients: Abiraterone acetate — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212462
Marketing start: Jul 16, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)
Identifiers: Product ID 60505-4764_0b559376-5181-40da-8b69-461bf4d1238eSPL ID 0b559376-5181-40da-8b69-461bf4d1238eSPL set ID 9ce9d926-ef3a-4b22-a703-f49c18eb4e3dRxCUI 1918042UNII EM5OCB9YJ6
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

N460505476406 followed by a unit qualifier and the quantity

Package 60505-4764-06. 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 Oct 18, 2023.

Indications (excerpt from the label)

Abiraterone acetate is 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 is 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212462

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212462
Product	Strength	Form · route	Labeler	Product NDC
abiraterone acetate	Abiraterone acetate 250 mg/1	TabletOral	Florida Pharmaceutical Products, LLC.	71921-178