Prescription drug · ANDA
Linezolid NDC 71335-2565
Linezolid 600 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2565-1 | 71335256501 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2565-1)Marketed from Jan 28, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-2565_c8913686-e7a0-451f-a345-9a8fd6e167dfSPL ID c8913686-e7a0-451f-a345-9a8fd6e167dfSPL set ID ab1b4ab5-7338-4b01-963b-43eeb4c9cf1cRxCUI 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
N471335256501followed by a unit qualifier and the quantityPackage 71335-2565-01. 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.
About NDC 71335-2565
- What is NDC 71335-2565?
- 71335-2565 is the product NDC for Linezolid, Linezolid 600 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 205517
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 600 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6553 |
| Linezolid | Linezolid 600 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8044 |
| Linezolid | Linezolid 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-419 |
| Linezolid | Linezolid 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4034 |
| Linezolid | Linezolid 600 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-231 |