Prescription drug · ANDA
Linezolid NDC 63323-713
Linezolid 2 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-713-13 | 63323071313 | 10 BAG in 1 CASE (63323-713-13) / 300 mL in 1 BAG (63323-713-03)Marketed from Jun 22, 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 — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204764
- Marketing start
- Listing expires
- Other FDA classes
- Oxazolidinones (Chemical structure)
- Identifiers
- Product ID 63323-713_d151d608-d9c5-4b78-b99b-f0cb53e6c439SPL ID d151d608-d9c5-4b78-b99b-f0cb53e6c439SPL set ID cc3e3ea4-50aa-49ee-a8bc-fb48bfc8e014RxCUI 1662285UNII 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 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.
- NDC on a medical claim
N463323071313followed by a unit qualifier and the quantityPackage 63323-0713-13. 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 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 day…
Excerpt only. Read the full label for complete information.
About NDC 63323-713
- What is NDC 63323-713?
- 63323-713 is the product NDC for Linezolid, Linezolid 2 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, 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?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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.
Related NDCs: other Linezolid products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 204764
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Linezolid | Linezolid 2 mg/mL | Injection, SolutionIntravenous | Hp Halden Pharma AS | 66298-7131 |