NDC codes

FDA NDC Directory
Product NDC (as listed)62135-442Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0442Add 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
62135-442-206213504422020 TABLET in 1 BOTTLE (62135-442-20)Marketed from Feb 21, 2023

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/1
Dosage form
Tablet
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210702
Marketing start
Listing expires
Other FDA classes
Oxazolidinones (Chemical structure)
Identifiers
Product ID 62135-442_42c9dc2a-45a8-d122-e063-6294a90ac4c5SPL ID 42c9dc2a-45a8-d122-e063-6294a90ac4c5SPL set ID 9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cfRxCUI 311347UNII ISQ9I6J12JUPC 0362135442200
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

N462135044220 followed by a unit qualifier and the quantity

Package 62135-0442-20. 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 indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [ see Warnings and Precautions (5.4) ]. 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 ( 1.1 ); Complicated skin and skin structure infec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-442

What is NDC 62135-442?
62135-442 is the product NDC for linezolid, Linezolid 600 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. 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?
Chartwell RX, LLC, NDC labeler code 62135. 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

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