Abiraterone Acetate NDC 0378-6921

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-6921Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-6921Add 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
0378-6921-91	00378692191	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6921-91)Marketed from Dec 14, 2020

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 Acetate
Generic name (nonproprietary): abiraterone acetate
Active ingredients: Abiraterone acetate — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208446
Marketing start: Dec 14, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)
Identifiers: Product ID 0378-6921_18e5ffff-c938-46e0-bf7a-1c1ab44e8a6dSPL ID 18e5ffff-c938-46e0-bf7a-1c1ab44e8a6dSPL set ID fe02db79-fa04-441f-b514-70bd74af6624RxCUI 1100075, 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

N400378692191 followed by a unit qualifier and the quantity

Package 00378-6921-91. 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 Apr 15, 2026.

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 208446

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

FDA NDC Directory listings under ANDA 208446
Product	Strength	Form · route	Labeler	Product NDC
Abiraterone Acetate	Abiraterone acetate 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2151
Abiraterone Acetate	Abiraterone acetate 500 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-989
Abiraterone Acetate	Abiraterone acetate 250 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-6920