Prescription drug · NDA
Zyvox (Linezolid) NDC 0009-5138
Linezolid 600 mg/1 · Tablet, Film coated · Oral · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-5138-02 | 00009513802 | 20 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02)Marketed from Oct 12, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Zyvox
- Generic name (nonproprietary)
- linezolid
- Active ingredients
- Linezolid — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pharmacia & Upjohn Company LLCNDC labeler code 0009
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021130
- Marketing start
- Marketing end
- Other FDA classes
- Oxazolidinones (Chemical structure)
- Identifiers
- Product ID 0009-5138_59c9a143-a1fa-4eeb-8fb1-dfe22de98d43SPL ID 59c9a143-a1fa-4eeb-8fb1-dfe22de98d43SPL set ID 6e70e63b-bfd5-478d-a8ee-8ba22c9efabdRxCUI 262091, 311345, 311347, 581614, 1662278, 1662280, 1662285, 1662286UNII ISQ9I6J12JUPC 0300095138023
- 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
N400009513802followed by a unit qualifier and the quantityPackage 00009-5138-02. 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)
ZYVOX 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 ) : • ZYVOX is not indicated for the treatment of Gram-negative infections. • The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controll…
Excerpt only. Read the full label for complete information.
About NDC 0009-5138
- What is NDC 0009-5138?
- 0009-5138 is the product NDC for Zyvox (linezolid), Linezolid 600 mg/1 tablet, film coated, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zyvox (Linezolid).
- What is the active ingredient?
- Linezolid.
- Who is the labeler?
- Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zyvox?
- 6 other product NDCs are listed under this name. See all Zyvox NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zyvox products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zyvoxlinezolid | Linezolid 600 mg/300mL | Injection, SolutionIntravenous | Hp Halden Pharma AS | 66298-5140 | 66298-5140-01 |
| Zyvoxlinezolid | Linezolid 600 mg/300mL | InjectionIntravenous | Hp Halden Pharma AS | 66298-7807 | 66298-7807-01 |
| Zyvoxlinezolid | Linezolid 200 mg/100mL | Injection, SolutionIntravenous | Hp Halden Pharma AS | 66298-5137 | 66298-5137-01 |
| Zyvoxlinezolid | Linezolid 600 mg/300mL | Injection, SolutionIntravenous | Pharmacia & Upjohn Company LLC | 0009-7807 | 00009-7807-02 |
| Zyvoxlinezolid | Linezolid 600 mg/300mL | Injection, SolutionIntravenous | Pharmacia & Upjohn Company LLC | 0009-5140 | 00009-5140-04 |
| Zyvoxlinezolid | Linezolid 100 mg/5mL | Granule, For suspensionOral | Pharmacia & Upjohn Company LLC | 0009-5136 | 00009-5136-04 |