Prescription drug · ANDA
Linezolid NDC 43386-022
Linezolid 600 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Linezolid
- Generic name (nonproprietary)
- linezolid
- Active ingredients
- Linezolid — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207526
- Marketing start
- Listing expires
- Other FDA classes
- Oxazolidinones (Chemical structure)
- Identifiers
- Product ID 43386-022_74f11ed7-8e21-4310-975e-f88609d5aa4eSPL ID 74f11ed7-8e21-4310-975e-f88609d5aa4eSPL set ID b3c55eb4-50f2-47f0-a424-5a6779518e1dRxCUI 311347UNII ISQ9I6J12JUPC 0343386022052
- 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Linezolid tablets are 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 formulations given for longer than 28 days have not been e…
Excerpt only. Read the full label for complete information.
About NDC 43386-022
- What is NDC 43386-022?
- 43386-022 is the product NDC for Linezolid, Linezolid 600 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc..
- What drug is associated with this NDC?
- Linezolid.
- What is the active ingredient?
- Linezolid.
- Who is the labeler?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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 |