Linezolid NDC 0054-0319

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0319Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0319Add 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
0054-0319-50	00054031950	150 mL in 1 BOTTLE (0054-0319-50)Marketed from Jun 3, 2015

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 — 100 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200068
Marketing start: Jun 3, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Oxazolidinones (Chemical structure)
Identifiers: Product ID 0054-0319_9eef61e8-dd27-4b8b-a3d3-e5100af2bceeSPL ID 9eef61e8-dd27-4b8b-a3d3-e5100af2bceeSPL set ID 16007ca5-7956-4414-af38-406a6623400eRxCUI 311345UNII 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

N400054031950 followed by a unit qualifier and the quantity

Package 00054-0319-50. 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 Jul 15, 2026.

Indications (excerpt from the label)

Linezolid for Oral Suspension 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); Uncomplicated skin and skin structure infections ( 1. 4); 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)