What is NDC 63629-8308?

63629-8308 is the product NDC for Bicalutamide, Bicalutamide 50 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 63629-8308 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8308Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8308Add 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
63629-8308-1	63629830801	30 TABLET in 1 BOTTLE (63629-8308-1)Marketed from Jun 8, 2021
63629-8308-2	63629830802	100 TABLET in 1 BOTTLE (63629-8308-2)Marketed from Mar 16, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078917
Marketing start: Jul 6, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Androgen Receptor Antagonists (Mechanism)
Identifiers: Product ID 63629-8308_01c32f48-8661-4d25-8e50-c6c97180cc42SPL ID 01c32f48-8661-4d25-8e50-c6c97180cc42SPL set ID 6d27f9b0-6b93-42fa-807e-fc819c0da14fRxCUI 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

N463629830801 followed by a unit qualifier and the quantity

Package 63629-8308-01. 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 Apr 3, 2024.

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)

About NDC 63629-8308

What is NDC 63629-8308?: 63629-8308 is the product NDC for Bicalutamide, Bicalutamide 50 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?: Bryant Ranch Prepack, NDC labeler code 63629. 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	Accord Healthcare Inc.	16729-023	16729-0023-0116729-0023-10
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 078917

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

FDA NDC Directory listings under ANDA 078917
Product	Strength	Form · route	Labeler	Product NDC
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Proficient Rx LP	71205-577
Bicalutamide	Bicalutamide 50 mg/1	TabletOral	Accord Healthcare Inc.	16729-023