Abiraterone (abiraterone acetate) NDC 0143-9597

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9597Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9597Add 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
0143-9597-21	00143959721	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.
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 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

N400143959721 followed by a unit qualifier and the quantity

Package 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 Dec 20, 2024.

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.

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	CivicaScript, LLC	82249-010
Abirtegaabiraterone acetate	Abiraterone acetate 250 mg/1	TabletOral, Oral	CivicaScript, LLC	82249-011