Abiraterone Acetate NDC 43598-358

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-358Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0358Add 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
43598-358-04	43598035804	120 TABLET in 1 BOTTLE (43598-358-04)Marketed from May 19, 2020
43598-358-31	43598035831	3 BLISTER PACK in 1 CARTON (43598-358-31) / 10 TABLET in 1 BLISTER PACK (43598-358-79)Marketed from Dec 20, 2021

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 — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddys Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208416
Marketing start: May 19, 2020
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 43598-358_5e7f1aec-5727-4e71-1a05-55e8eef89e0aSPL ID 5e7f1aec-5727-4e71-1a05-55e8eef89e0aSPL set ID 7eda0d98-c2ba-c117-b757-1f566292e789RxCUI 1100075, 1918042UNII EM5OCB9YJ6UPC 0343598358048
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

N443598035804 followed by a unit qualifier and the quantity

Package 43598-0358-04. 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 Sep 4, 2023.

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 tablet 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 208416

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

FDA NDC Directory listings under ANDA 208416
Product	Strength	Form · route	Labeler	Product NDC
Abiraterone Acetate	Abiraterone acetate 500 mg/1	TabletOral	Dr. Reddys Laboratories Inc	43598-468
Abiraterone Acetate	Abiraterone acetate 250 mg/1	TabletOral	AvPAK	50268-032
Abiraterone Acetate	Abiraterone acetate 250 mg/1	TabletOral	NorthStar Rx LLC	16714-963
Abiraterone Acetate	Abiraterone acetate 250 mg/1	TabletOral	Dr. Reddys Laboratories Inc	75907-224