What is NDC 47335-485?

47335-485 is the product NDC for bicalutamide, Bicalutamide 50 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 47335-485 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-485Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0485Add 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
47335-485-08	47335048508	100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08)Marketed from Dec 15, 2014
47335-485-18	47335048518	1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18)Marketed from Dec 15, 2014
47335-485-83	47335048583	30 TABLET, FILM COATED in 1 BOTTLE (47335-485-83)Marketed from Dec 15, 2014
47335-485-88	47335048588	100 TABLET, FILM COATED in 1 BOTTLE (47335-485-88)Marketed from Dec 15, 2014

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, Film coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079110
Marketing start: Dec 15, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Androgen Receptor Antagonists (Mechanism)
Identifiers: Product ID 47335-485_3259c219-2548-4ea5-b6ad-e22f249879c7SPL ID 3259c219-2548-4ea5-b6ad-e22f249879c7SPL set ID 8b533fe4-287f-482c-b530-d9a5bf2ce40cRxCUI 199123UNII A0Z3NAU9DP
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

N447335048508 followed by a unit qualifier and the quantity

Package 47335-0485-08. 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 Jan 28, 2025.

Indications (excerpt from the label)

Bicalutamide tablets, USP 50 mg daily are 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, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2)]. Bicalutamide tablet 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 tablet 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 47335-485

What is NDC 47335-485?: 47335-485 is the product NDC for bicalutamide, Bicalutamide 50 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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	Proficient Rx LP	82804-082	82804-0082-90
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Accord Healthcare Inc.	16729-023	16729-0023-0116729-0023-10
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Bryant Ranch Prepack	63629-8308	63629-8308-0163629-8308-02
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Proficient Rx LP	71205-577	71205-0577-3071205-0577-6071205-0577-90
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Viona Pharmaceuticals Inc.	72578-215	72578-0215-0172578-0215-06
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 079110

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

FDA NDC Directory listings under ANDA 079110
Product	Strength	Form · route	Labeler	Product NDC
bicalutamide	Bicalutamide 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-082