Prescription drug · NDA
Tyzavan (vancomycin) NDC 0143-9471
Vancomycin 500 mg/100mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9471-06 | 00143947106 | 6 BAG in 1 CARTON (0143-9471-06) / 100 mL in 1 BAG (0143-9471-01)Marketed from Oct 17, 2025 | |
| 0143-9471-12 | 00143947112 | 12 BAG in 1 CARTON (0143-9471-12) / 100 mL in 1 BAG (0143-9471-01)Marketed from Oct 17, 2025 |
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)
- Tyzavan
- Generic name (nonproprietary)
- vancomycin
- Active ingredients
- Vancomycin — 500 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211962
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 0143-9471_7bddeff1-1858-437c-b772-b063a7e7c6f8SPL ID 7bddeff1-1858-437c-b772-b063a7e7c6f8SPL set ID 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560RxCUI 1807508, 1807510, 1807511, 2118448, 2118449, 2387078, 2387079, 2725135, 2727215, 2727216, 2727217, 2727218, 2727219, 2727220UNII 6Q205EH1VU
- Pharmacologic class
- Glycopeptide 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
N400143947106followed by a unit qualifier and the quantityPackage 00143-9471-06. 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)
TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYZAVAN and other antibacterial drugs, TYZAVAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Septicemia TYZAVAN is indicated in adults and pediatric patients…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 211962
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 |
|---|---|---|---|---|
| Tyzavanvancomycin | Vancomycin 750 mg/150mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9468 |
| Tyzavanvancomycin | Vancomycin 1.5 g/300mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9469 |
| Tyzavanvancomycin | Vancomycin 2 g/400mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9470 |
| Tyzavanvancomycin | Vancomycin 1 g/200mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9472 |
| Vancomycin | Vancomycin 1.5 g/300mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-043 |
| Vancomycin | Vancomycin 500 mg/100mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-041 |
| Vancomycin | Vancomycin 1 g/200mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-042 |
| Vancomycin | Vancomycin 2 g/400mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-044 |
| Vancomycin | Vancomycin 750 mg/150mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-056 |
| Vancomycin | Vancomycin 1.25 g/250mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-057 |
| Vancomycin | Vancomycin 1.75 g/350mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-058 |
| Tyzavanvancomycin | Vancomycin 1.25 g/250mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9466 |
| Tyzavanvancomycin | Vancomycin 1.75 g/350mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9467 |
- openFDA data updated
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