What is NDC 65145-181?

65145-181 is the product NDC for Linezolid, Linezolid 600 mg/300mL injection, solution, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Caplin Steriles Limited, NDC labeler code 65145. 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 65145-181 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65145-181Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65145-0181Add 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
65145-181-10	65145018110	10 POUCH in 1 CASE (65145-181-10) / 1 BAG in 1 POUCH (65145-181-01) / 300 mL in 1 BAGMarketed from Dec 23, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Caplin Steriles LimitedNDC labeler code 65145
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219558
Marketing start: Dec 23, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Oxazolidinones (Chemical structure)
Identifiers: Product ID 65145-181_2220c753-e0e8-4797-bce2-34b3c63bd631SPL ID 2220c753-e0e8-4797-bce2-34b3c63bd631SPL set ID 2220c753-e0e8-4797-bce2-34b3c63bd631RxCUI 1662285UNII ISQ9I6J12JUPC 0365145181015
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

N465145018110 followed by a unit qualifier and the quantity

Package 65145-0181-10. 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 Dec 23, 2025.

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 injection is not indicated for the treatment of Gram-negative infections. The safety and efficacy of linezolid injection formulation given for longer than 28 days have not been evaluated in controlled clinical trials. To…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65145-181

What is NDC 65145-181?: 65145-181 is the product NDC for Linezolid, Linezolid 600 mg/300mL injection, solution, listed with the FDA by Caplin Steriles Limited. 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?: Caplin Steriles Limited, NDC labeler code 65145. 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/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
Linezolid	Linezolid 100 mg/5mL	Granule, For suspensionOral	Camber Pharmaceuticals, Inc.	31722-865	31722-0865-25

All 33 Linezolid NDCs