Bicalutamide NDC 62559-890

NDC codes

FDA NDC Directory

Product NDC (as listed)62559-890Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62559-0890Add 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
62559-890-30	62559089030	30 TABLET in 1 BOTTLE (62559-890-30)Marketed from Oct 26, 2020

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): Bicalutamide
Generic name (nonproprietary): bicalutamide
Active ingredients: Bicalutamide — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020498
Marketing start: Oct 26, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Androgen Receptor Antagonists (Mechanism)
Identifiers: Product ID 62559-890_cf149c3a-84aa-4ef8-befc-1dbeb7dcc678SPL ID cf149c3a-84aa-4ef8-befc-1dbeb7dcc678SPL set ID 7a08d88b-051a-4c16-9560-12685c500c58RxCUI 199123UNII A0Z3NAU9DPUPC 0362559890304
Pharmacologic class: Androgen Receptor 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

N462559089030 followed by a unit qualifier and the quantity

Package 62559-0890-30. 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 Feb 27, 2026.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) • Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020498

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

FDA NDC Directory listings under NDA 020498
Product	Strength	Form · route	Labeler	Product NDC
Casodexbicalutamide	Bicalutamide 50 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-680
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-010