Linezolid NDC 0781-3433

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-3433Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-3433Add 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
0781-3433-95	00781343395	10 BAG in 1 CARTON (0781-3433-95) / 300 mL in 1 BAG (0781-3433-46)Marketed from Jun 15, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Linezolid
Generic name (nonproprietary): linezolid
Active ingredients: Linezolid — 600 mg/300mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Sandoz Inc
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 0781-3433_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

NDC on a medical claim

N400781343395 followed by a unit qualifier and the quantity

Package 00781-3433-95. 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 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)

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 200 mg/100mL	Injection, SolutionIntravenous	Sandoz Inc	0781-3431