What is NDC 63629-8576?

63629-8576 is the product NDC for Linezolid, Linezolid 600 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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 Linezolid?

32 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Linezolid NDC 63629-8576 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8576Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8576Add 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
63629-8576-1	6362985760163629857601	20 TABLET, FILM COATED in 1 BOTTLE (63629-8576-1)Marketed from Dec 16, 2021

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): Linezolid
Generic name (nonproprietary): linezolid
Active ingredients: Linezolid — 600 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204239
Marketing start: Dec 21, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Oxazolidinones (Chemical structure)
Identifiers: Product ID 63629-8576_0bf00238-038a-43dd-91bd-148aaa13f219SPL ID 0bf00238-038a-43dd-91bd-148aaa13f219SPL set ID 8a04bdc9-d6f0-4e35-b683-a472a2e4ff04RxCUI 311347UNII ISQ9I6J12J
Pharmacologic class: Oxazolidinone Antibacterial

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

N463629857601 followed by a unit qualifier and the quantity

Package 63629-8576-01. 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 26, 2025.

Indications (excerpt from the label)

Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions ( 5.4 )]. Linezolid is an oxazolidinone-class antibacterial indicated in adults for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1.1 ); Community-acquired pneumonia ( 1.1 ); Complicated skin and skin structure infections, includ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8576

What is NDC 63629-8576?: 63629-8576 is the product NDC for Linezolid, Linezolid 600 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Linezolid.
What is the active ingredient?: Linezolid.
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 Linezolid?: 32 other product NDCs are listed under this name. See all Linezolid 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 Linezolid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Linezolid	Linezolid 600 mg/300mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-181	65145-0181-10
Linezolid	Linezolid 600 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1576	67046-1576-03
Linezolid	Linezolid 600 mg/1	Tablet, CoatedOral	Macleods Pharmaceuticals Limited	33342-352	33342-0352-0633342-0352-1133342-0352-31+1 more
Linezolid	Linezolid 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4034	70518-4034-0070518-4034-01
Linezolid	Linezolid 600 mg/300mL	Injection, SolutionIntravenous	Piramal Critical Care Inc	66794-219	66794-0219-43
Linezolid	Linezolid 600 mg/300mL	InjectionIntravenous	Piramal Critical Care Inc.	66794-236	66794-0236-43
Linezolid	Linezolid 600 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-561	64980-0561-0264980-0561-03
Linezolid	Linezolid 600 mg/1	TabletOral	Sportpharm LLC	85766-075	85766-0075-2085766-0075-30
Linezolid	Linezolid 100 mg/5mL	Granule, For suspensionOral	American Health Packaging	60687-754	60687-0754-05
Linezolid	Linezolid 600 mg/300mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9534	00143-9534-10

All 33 Linezolid NDCs

Other NDCs under ANDA 204239

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

FDA NDC Directory listings under ANDA 204239
Product	Strength	Form · route	Labeler	Product NDC
Linezolid	Linezolid 600 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-749
Linezolid	Linezolid 600 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-309
Linezolid	Linezolid 600 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1576