What is NDC 0378-6920?

0378-6920 is the product NDC for Abiraterone Acetate, Abiraterone acetate 250 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Abiraterone Acetate?

28 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Abiraterone Acetate NDC 0378-6920 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-6920Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-6920Add 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
0378-6920-78	0037869207800378692078	120 TABLET in 1 BOTTLE, PLASTIC (0378-6920-78)Marketed from Nov 21, 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 Acetate
Generic name (nonproprietary): abiraterone acetate
Active ingredients: Abiraterone acetate — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208446
Marketing start: Nov 21, 2018
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 0378-6920_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

N400378692078 followed by a unit qualifier and the quantity

Package 00378-6920-78. 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)

About NDC 0378-6920

What is NDC 0378-6920?: 0378-6920 is the product NDC for Abiraterone Acetate, Abiraterone acetate 250 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Abiraterone Acetate.
What is the active ingredient?: Abiraterone acetate.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Abiraterone Acetate?: 28 other product NDCs are listed under this name. See all Abiraterone Acetate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Abiraterone Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Abiraterone Acetate	Abiraterone acetate 250 mg/1	TabletOral	AvPAK	50268-032	50268-0032-12
Abiraterone Acetate	Abiraterone acetate 250 mg/1	TabletOral	Dr. Reddys Laboratories Inc	75907-224	75907-0224-04
Abiraterone Acetateabiraterone	Abiraterone acetate 250 mg/1	TabletOral	American Health Packaging	60687-790	60687-0790-21
Abiraterone Acetate	Abiraterone acetate 500 mg/1	TabletOral	Dr. Reddys Laboratories Inc	43598-468	43598-0468-3843598-0468-60
Abiraterone Acetateabiraterone	Abiraterone acetate 250 mg/1	TabletOral	Amneal Pharmaceuticals LLC	60219-1165	60219-1165-07
Abiraterone Acetateabiraterone	Abiraterone acetate 500 mg/1	TabletOral	Amneal Pharmaceuticals LLC	60219-1754	60219-1754-06
Abiraterone acetate	Abiraterone acetate 500 mg/1	Tablet, Film coatedOral	Florida Pharmaceutical Products, LLC	71921-177	71921-0177-06
abiraterone acetate	Abiraterone acetate 250 mg/1	TabletOral	Florida Pharmaceutical Products, LLC.	71921-178	71921-0178-20
abiraterone acetate	Abiraterone acetate 500 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-882	68462-0882-60
abiraterone acetate	Abiraterone acetate 500 mg/1	TabletOral	NORTHSTAR RX LLC	72603-111	72603-0111-01

All 29 Abiraterone Acetate NDCs

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	Mylan Pharmaceuticals Inc.	0378-6921
Abiraterone Acetate	Abiraterone acetate 500 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-989
Abiraterone Acetate	Abiraterone acetate 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2151