NDC codes

FDA NDC Directory
Product NDC (as listed)59762-1308Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59762-1308Add 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 NDC11-digit (billing)PackageCopy
59762-1308-459762130804150 mL in 1 BOTTLE (59762-1308-4)Marketed from Mar 30, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Suspension
Route
Oral
Labeler
Mylan Pharmaceuticals Inc.NDC labeler code 59762
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021132
Marketing start
Listing expires
Other FDA classes
Oxazolidinones (Chemical structure)
Identifiers
Product ID 59762-1308_7975b1d1-2e16-499f-92ae-2900117d6887SPL ID 7975b1d1-2e16-499f-92ae-2900117d6887SPL set ID 83a84897-ccca-42a1-ab1a-bbf1d43a982bRxCUI 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

N459762130804 followed by a unit qualifier and the quantity

Package 59762-1308-04. 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 .

Indications (excerpt from the label)

Linezolid 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 not been evaluated …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59762-1308

What is NDC 59762-1308?
59762-1308 is the product NDC for Linezolid, Linezolid 100 mg/5mL suspension, listed with the FDA by Mylan Pharmaceuticals 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?
Mylan Pharmaceuticals Inc., NDC labeler code 59762. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LinezolidLinezolid 600 mg/300mLInjection, SolutionIntravenousCaplin Steriles Limited65145-18165145-0181-10
LinezolidLinezolid 600 mg/1Tablet, Film coatedOralCoupler LLC67046-157667046-1576-03
LinezolidLinezolid 600 mg/1Tablet, CoatedOralMacleods Pharmaceuticals Limited33342-35233342-0352-0633342-0352-1133342-0352-31+1 more
LinezolidLinezolid 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-403470518-4034-0070518-4034-01
LinezolidLinezolid 600 mg/300mLInjection, SolutionIntravenousPiramal Critical Care Inc66794-21966794-0219-43
LinezolidLinezolid 600 mg/300mLInjectionIntravenousPiramal Critical Care Inc.66794-23666794-0236-43
LinezolidLinezolid 600 mg/1TabletOralRising Pharma Holdings, Inc.64980-56164980-0561-0264980-0561-03
LinezolidLinezolid 600 mg/1TabletOralSportpharm LLC85766-07585766-0075-2085766-0075-30
LinezolidLinezolid 100 mg/5mLGranule, For suspensionOralAmerican Health Packaging60687-75460687-0754-05
LinezolidLinezolid 600 mg/300mLInjection, SolutionIntravenousHikma Pharmaceuticals USA Inc.0143-953400143-9534-10

All 33 Linezolid NDCs

Other NDCs under NDA 021132

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

FDA NDC Directory listings under NDA 021132
ProductStrengthForm · routeLabelerProduct NDC
ZyvoxlinezolidLinezolid 100 mg/5mLGranule, For suspensionOralPharmacia & Upjohn Company LLC0009-5136

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