What is NDC 57894-100?

57894-100 is the product NDC for Akeega, Niraparib tosylate monohydrate 100 mg/1; Abiraterone acetate 500 mg/1 tablet, film coated, listed with the FDA by Janssen Biotech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Akeega (NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE).

What is the active ingredient?

Niraparib tosylate monohydrate, Abiraterone acetate.

Janssen Biotech, Inc., NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Akeega?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Akeega NDC 57894-100 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57894-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57894-0100Add 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
57894-100-60	57894010060	1 BOTTLE in 1 CARTON (57894-100-60) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 11, 2023

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): Akeega
Generic name (nonproprietary): niraparib tosylate monohydrate and abiraterone acetate
Active ingredients: Niraparib tosylate monohydrate — 100 mg/1Abiraterone acetate — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Janssen Biotech, Inc.NDC labeler code 57894
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216793
Marketing start: Aug 11, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Poly(ADP-Ribose) Polymerase Inhibitors (Mechanism)
Identifiers: Product ID 57894-100_463bff67-d7cf-a132-e063-6394a90abe1dSPL ID 463bff67-d7cf-a132-e063-6394a90abe1dSPL set ID 8245a990-3268-4613-b5c5-9537858a1eb9RxCUI 2645244, 2645250, 2645251, 2645253UNII EM5OCB9YJ6, 195Q483UZD
Pharmacologic class: Cytochrome P450 17A1 Inhibitor; Poly(ADP-Ribose) Polymerase 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

N457894010060 followed by a unit qualifier and the quantity

Package 57894-0100-60. 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 18, 2025.

Indications (excerpt from the label)

AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ] . AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with: …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57894-100

What is NDC 57894-100?: 57894-100 is the product NDC for Akeega, Niraparib tosylate monohydrate 100 mg/1; Abiraterone acetate 500 mg/1 tablet, film coated, listed with the FDA by Janssen Biotech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Akeega (NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE).
What is the active ingredient?: Niraparib tosylate monohydrate, Abiraterone acetate.
Who is the labeler?: Janssen Biotech, Inc., NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Akeega?: 1 other product NDC are listed under this name. See all Akeega 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 Akeega NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Akeeganiraparib tosylate monohydrate and abiraterone acetate	Niraparib tosylate monohydrate 50 mg/1; Abiraterone acetate 500 mg/1	Tablet, Film coatedOral	Janssen Biotech, Inc.	57894-050	57894-0050-60

Other NDCs under NDA 216793

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

FDA NDC Directory listings under NDA 216793
Product	Strength	Form · route	Labeler	Product NDC
Akeeganiraparib tosylate monohydrate and abiraterone acetate	Niraparib tosylate monohydrate 50 mg/1; Abiraterone acetate 500 mg/1	Tablet, Film coatedOral	Janssen Biotech, Inc.	57894-050