What is NDC 57664-682?

57664-682 is the product NDC for Linezolid, Linezolid 200 mg/100mL injection, solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. 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 57664-682 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57664-682Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57664-0682Add 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
57664-682-30	5766406823057664068230	100 mL in 1 BAG (57664-682-30)Marketed from Feb 1, 2017

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 — 200 mg/100mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207354
Marketing start: Feb 1, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Oxazolidinones (Chemical structure)
Identifiers: Product ID 57664-682_d717dddc-2ff8-4953-8efc-c86ad9342f7dSPL ID d717dddc-2ff8-4953-8efc-c86ad9342f7dSPL set ID 870c9600-04d5-4b44-a5b5-02252a310f22RxCUI 1662278, 1662285UNII ISQ9I6J12JUPC 0357664683316, 0357664682302
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

N457664068230 followed by a unit qualifier and the quantity

Package 57664-0682-30. 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 31, 2026.

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 ); Uncomplicated skin and skin structure infections ( 1.4 ); 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 formulations given for longer than 28 da…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57664-682

What is NDC 57664-682?: 57664-682 is the product NDC for Linezolid, Linezolid 200 mg/100mL injection, solution, listed with the FDA by Sun Pharmaceutical Industries, 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. 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

Other NDCs under ANDA 207354

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

FDA NDC Directory listings under ANDA 207354
Product	Strength	Form · route	Labeler	Product NDC
Linezolid	Linezolid 600 mg/300mL	Injection, SolutionIntravenous	Sun Pharmaceutical Industries, Inc.	57664-683