Prescription drug · ANDA
Linezolid NDC 31722-749
Linezolid 600 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-749-01 | 3172207490131722074901 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-749-01)Marketed from Dec 21, 2015 | |
| 31722-749-20 | 3172207492031722074920 | 20 TABLET, FILM COATED in 1 BOTTLE (31722-749-20)Marketed from Dec 21, 2015 | |
| 31722-749-30 | 3172207493031722074930 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-749-30)Marketed from Dec 21, 2015 | |
| 31722-749-31 | 3172207493131722074931 | 150 TABLET, FILM COATED in 1 CARTON (31722-749-31)Marketed from Dec 21, 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 — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204239
- Marketing start
- Listing expires
- Other FDA classes
- Oxazolidinones (Chemical structure)
- Identifiers
- Product ID 31722-749_2b439d9f-d081-c988-e063-6394a90af390SPL ID 2b439d9f-d081-c988-e063-6394a90af390SPL set ID b239458e-9a3e-49ac-9ac7-a4badc53dff6RxCUI 311347UNII ISQ9I6J12JUPC 0331722749206
- 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
N431722074901followed by a unit qualifier and the quantityPackage 31722-0749-01. 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 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 eval…
Excerpt only. Read the full label for complete information.
About NDC 31722-749
- What is NDC 31722-749?
- 31722-749 is the product NDC for Linezolid, Linezolid 600 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 4 package NDCs, 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 204239
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 | American Health Packaging | 60687-309 |
| Linezolid | Linezolid 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8576 |
| Linezolid | Linezolid 600 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1576 |