Abirtega (abiraterone acetate) NDC 82249-011

NDC codes

FDA NDC Directory

Product NDC (as listed)82249-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82249-0011Add 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
82249-011-12	82249001112	120 TABLET in 1 BOTTLE, PLASTIC (82249-011-12)Marketed from Jan 17, 2025

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): Abirtega
Generic name (nonproprietary): abiraterone acetate
Active ingredients: Abiraterone acetate — 250 mg/1
Dosage form: Tablet
Route: Oral, Oral
Labeler: CivicaScript, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208339
Marketing start: Nov 23, 2018
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 82249-011_692d596d-5465-4611-82f7-5d50c37270a2SPL ID 692d596d-5465-4611-82f7-5d50c37270a2SPL set ID 2f932015-28b2-4f44-ac04-772e982e13e9RxCUI 1100075, 2702601UNII EM5OCB9YJ6UPC 0382249011123
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, Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N482249001112 followed by a unit qualifier and the quantity

Package 82249-0011-12. 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 Feb 28, 2025.

Indications (excerpt from the label)

ABIRTEGA 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) ABIRTEGA 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 208339

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

FDA NDC Directory listings under ANDA 208339
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
Abirateroneabiraterone acetate	Abiraterone acetate 250 mg/1	TabletOral	CivicaScript, LLC	82249-010