What is NDC 67046-1576?

67046-1576 is the product NDC for Linezolid, Linezolid 600 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. 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 67046-1576 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1576Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1576Add 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
67046-1576-3	67046157603	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1576-3)Marketed from Sep 4, 2025

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: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204239
Marketing start: Sep 4, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Oxazolidinones (Chemical structure)
Identifiers: Product ID 67046-1576_3dff6e84-a494-5993-e063-6394a90aa8f1SPL ID 3dff6e84-a494-5993-e063-6394a90aa8f1SPL set ID 3dff6eec-8662-335f-e063-6294a90ab159RxCUI 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

N467046157603 followed by a unit qualifier and the quantity

Package 67046-1576-03. 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 Sep 4, 2025.

Indications (excerpt from the label)

Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5) Limitations of Use (1.6): • Linezolid tablets are not indicated for the treatment of Gram-negative infections. • The safety and efficacy of linezolid formulations given for longer than 28 days have not been eval…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1576

What is NDC 67046-1576?: 67046-1576 is the product NDC for Linezolid, Linezolid 600 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. 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?: Coupler LLC, NDC labeler code 67046. 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, 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
Linezolid	Linezolid 100 mg/5mL	Granule, For suspensionOral	Camber Pharmaceuticals, Inc.	31722-865	31722-0865-25

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	Bryant Ranch Prepack	63629-8576