NDC codes

FDA NDC Directory
Product NDC (as listed)67877-419Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0419Add 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
67877-419-0167877041901100 TABLET, FILM COATED in 1 BOTTLE (67877-419-01)Marketed from Dec 21, 2015
67877-419-0567877041905500 TABLET, FILM COATED in 1 BOTTLE (67877-419-05)Marketed from Dec 21, 2015
67877-419-10678770419101000 TABLET, FILM COATED in 1 BOTTLE (67877-419-10)Marketed from Dec 21, 2015
67877-419-206787704192020 TABLET, FILM COATED in 1 BOTTLE (67877-419-20)Marketed from Dec 21, 2015
67877-419-33678770419331 BLISTER PACK in 1 CARTON (67877-419-33) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 21, 2015
67877-419-386787704193810 BLISTER PACK in 1 CARTON (67877-419-38) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 21, 2015
67877-419-84678770419843 BLISTER PACK in 1 CARTON (67877-419-84) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 21, 2015
67877-419-85678770419852 BLISTER PACK in 1 CARTON (67877-419-85) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 21, 2015

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, Film coated
Route
Oral
Labeler
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205517
Marketing start
Listing expires
Other FDA classes
Oxazolidinones (Chemical structure)
Identifiers
Product ID 67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381cSPL ID 1dd1fb9c-98f4-4e25-8246-fb8462ff381cSPL set ID 7402aa01-50de-46c8-a341-d30da5b32b1cRxCUI 311347UNII 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

N467877041901 followed by a unit qualifier and the quantity

Package 67877-0419-01. 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 tablets are not indicated for the treatment of Gram-negative infections. The safety and efficacy of linezolid tablets formulations given for longer than 28 days have not been…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67877-419

What is NDC 67877-419?
67877-419 is the product NDC for Linezolid, Linezolid 600 mg/1 tablet, film coated, listed with the FDA by Ascend Laboratories, LLC. It has 8 package NDCs, 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?
Ascend Laboratories, LLC, NDC labeler code 67877. 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 ANDA 205517

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

FDA NDC Directory listings under ANDA 205517
ProductStrengthForm · routeLabelerProduct NDC
LinezolidLinezolid 600 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6553
LinezolidLinezolid 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8044
LinezolidLinezolid 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4034
LinezolidLinezolid 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2565
LinezolidLinezolid 600 mg/1Tablet, Film coatedOralSportpharm LLC85766-231

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