Prescription drug · NDA
Zyvox (Linezolid) NDC 66298-5137
Linezolid 200 mg/100mL · Injection, Solution · Intravenous · Hp Halden Pharma AS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66298-5137-1 | 66298513701 | 100 mL in 1 BAG (66298-5137-1)Marketed from Jun 4, 2018 |
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)
- Zyvox
- Generic name (nonproprietary)
- linezolid
- Active ingredients
- Linezolid — 200 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hp Halden Pharma ASNDC labeler code 66298
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021131
- Marketing start
- Listing expires
- Other FDA classes
- Oxazolidinones (Chemical structure)
- Identifiers
- Product ID 66298-5137_1988348c-3b04-2b38-e063-6394a90ada27SPL ID 1988348c-3b04-2b38-e063-6394a90ada27SPL set ID ce57225b-4580-442b-8c48-8045297cbb50RxCUI 1662278, 1662280UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N466298513701followed by a unit qualifier and the quantityPackage 66298-5137-01. 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)
ZYVOX is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. ZYVOX 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) ]. 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 ( 1.1 ); Complicated skin and skin structure infections, inclu…
Excerpt only. Read the full label for complete information.
About NDC 66298-5137
- What is NDC 66298-5137?
- 66298-5137 is the product NDC for Zyvox (linezolid), Linezolid 200 mg/100mL injection, solution, listed with the FDA by Hp Halden Pharma AS. 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?
- Hp Halden Pharma AS, NDC labeler code 66298. 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 600 mg/1 | Tablet, Film coatedOral | Pharmacia & Upjohn Company LLC | 0009-5138 | 00009-5138-02 |
| 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 |
Other NDCs under NDA 021131
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 |
|---|---|---|---|---|
| Zyvoxlinezolid | Linezolid 600 mg/300mL | Injection, SolutionIntravenous | Pharmacia & Upjohn Company LLC | 0009-5140 |
| Zyvoxlinezolid | Linezolid 600 mg/300mL | Injection, SolutionIntravenous | Hp Halden Pharma AS | 66298-5140 |
| Zyvoxlinezolid | Linezolid 600 mg/300mL | InjectionIntravenous | Hp Halden Pharma AS | 66298-7807 |
| Zyvoxlinezolid | Linezolid 600 mg/300mL | Injection, SolutionIntravenous | Pharmacia & Upjohn Company LLC | 0009-7807 |