What is NDC 72578-215?

72578-215 is the product NDC for Bicalutamide, Bicalutamide 50 mg/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc., NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bicalutamide?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bicalutamide NDC 72578-215 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-215Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0215Add 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
72578-215-01	72578021501	100 TABLET in 1 BOTTLE (72578-215-01)Marketed from Jun 7, 2009
72578-215-06	72578021506	30 TABLET in 1 BOTTLE (72578-215-06)Marketed from Jun 7, 2009

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: Viona Pharmaceuticals Inc.NDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079089
Marketing start: Jun 7, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Androgen Receptor Antagonists (Mechanism)
Identifiers: Product ID 72578-215_7f9961d0-109d-4640-bedc-319663483652SPL ID 7f9961d0-109d-4640-bedc-319663483652SPL set ID 5a7cbe80-f119-4b3d-949a-c7824ea91908RxCUI 199123UNII A0Z3NAU9DPUPC 0372578215064, 0372578215019
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

N472578021501 followed by a unit qualifier and the quantity

Package 72578-0215-01. 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 Aug 19, 2025.

Indications (excerpt from the label)

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)

About NDC 72578-215

What is NDC 72578-215?: 72578-215 is the product NDC for Bicalutamide, Bicalutamide 50 mg/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bicalutamide.
What is the active ingredient?: Bicalutamide.
Who is the labeler?: Viona Pharmaceuticals Inc., NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bicalutamide?: 8 other product NDCs are listed under this name. See all Bicalutamide 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 Bicalutamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-890	62559-0890-30
bicalutamide	Bicalutamide 50 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-485	47335-0485-0847335-0485-1847335-0485-83+1 more
bicalutamide	Bicalutamide 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-082	82804-0082-90
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Proficient Rx LP	71205-577	71205-0577-3071205-0577-6071205-0577-90
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Bryant Ranch Prepack	63629-8308	63629-8308-0163629-8308-02
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Accord Healthcare Inc.	16729-023	16729-0023-0116729-0023-10
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	PINNACLE LIFE SCIENCE PRIVATE LIMITED	84508-001	84508-0001-0184508-0001-30
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-010	51407-0010-30

Other NDCs under ANDA 079089

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

FDA NDC Directory listings under ANDA 079089
Product	Strength	Form · route	Labeler	Product NDC
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	PINNACLE LIFE SCIENCE PRIVATE LIMITED	84508-001