Prescription drug · ANDA
linezolid NDC 62135-442
Linezolid 600 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-442-20 | 62135044220 | 20 TABLET in 1 BOTTLE (62135-442-20)Marketed from Feb 21, 2023 |
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
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210702
- Marketing start
- Listing expires
- Other FDA classes
- Oxazolidinones (Chemical structure)
- Identifiers
- Product ID 62135-442_42c9dc2a-45a8-d122-e063-6294a90ac4c5SPL ID 42c9dc2a-45a8-d122-e063-6294a90ac4c5SPL set ID 9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cfRxCUI 311347UNII ISQ9I6J12JUPC 0362135442200
- 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
N462135044220followed by a unit qualifier and the quantityPackage 62135-0442-20. 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 indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [ see Warnings and Precautions (5.4) ]. 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 ( 1.1 ); Complicated skin and skin structure infec…
Excerpt only. Read the full label for complete information.
About NDC 62135-442
- What is NDC 62135-442?
- 62135-442 is the product NDC for linezolid, Linezolid 600 mg/1 tablet, listed with the FDA by Chartwell RX, 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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 |