What is NDC 0054-0319?

0054-0319 is the product NDC for Linezolid, Linezolid 100 mg/5mL powder, for suspension, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 0054-0319 | National Drug Code

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	0005403195000054031950	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.NDC labeler code 0054
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 17, 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)

About NDC 0054-0319

What is NDC 0054-0319?: 0054-0319 is the product NDC for Linezolid, Linezolid 100 mg/5mL powder, for suspension, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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