What is NDC 0781-3431?

0781-3431 is the product NDC for Linezolid, Linezolid 200 mg/100mL injection, solution, listed with the FDA by Sandoz Inc.

Sandoz Inc, NDC labeler code 0781. 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 0781-3431 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-3431Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-3431Add the package segment from the table below.

Product information

Brand name (proprietary): Linezolid
Generic name (nonproprietary): linezolid
Active ingredients: Linezolid — 200 mg/100mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200904
Marketing start: Jun 15, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Oxazolidinones (Chemical structure)
Identifiers: Product ID 0781-3431_1cfcbbf5-11a6-44a4-a36f-5f77931baec1SPL ID 1cfcbbf5-11a6-44a4-a36f-5f77931baec1SPL set ID a287cdf4-47a8-459f-8890-86181af5e836RxCUI 1662278, 1662285UNII ISQ9I6J12JUPC 0307813431466
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

Product label

Current FDA label (SPL), effective Jun 15, 2026.

Indications (excerpt from the label)

Linezolid injection is 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 ); Vancomycin-resistant Enterococcus faecium infections. ( 1.5 ) Limitations of Use ( 1.6 ): • Linezolid is 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 evaluated in controlled clinical trials. To reduce the dev…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3431

What is NDC 0781-3431?: 0781-3431 is the product NDC for Linezolid, Linezolid 200 mg/100mL injection, solution, listed with the FDA by Sandoz Inc.
What drug is associated with this NDC?: Linezolid.
What is the active ingredient?: Linezolid.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. 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 200904

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

FDA NDC Directory listings under ANDA 200904
Product	Strength	Form · route	Labeler	Product NDC
Linezolid	Linezolid 600 mg/300mL	Injection, SolutionIntravenous	Sandoz Inc	0781-3433