Prescription drug · NDA
Vancomycin NDC 70594-057
Vancomycin 1.25 g/250mL · Injection, Solution · Intravenous · Xellia Pharmaceuticals USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70594-057-02 | 7059400570270594005702 | 6 BAG in 1 CARTON (70594-057-02) / 250 mL in 1 BAG (70594-057-01)Marketed from May 13, 2020 |
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)
- Vancomycin
- Generic name (nonproprietary)
- vancomycin
- Active ingredients
- Vancomycin — 1.25 g/250mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Xellia Pharmaceuticals USA LLCNDC labeler code 70594
- 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 70594-057_e49b6589-caca-4c8f-8c57-55a1ee7774ccSPL ID e49b6589-caca-4c8f-8c57-55a1ee7774ccSPL set ID 60bee69b-be70-412c-9e83-a24a0a8a5e7bRxCUI 1807508, 1807510, 1807511, 2118448, 2118449, 2387078, 2387079UNII 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
N470594005702followed by a unit qualifier and the quantityPackage 70594-0057-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: 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 Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.6 ) 1.1 Septicemia Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for th…
Excerpt only. Read the full label for complete information.
About NDC 70594-057
- What is NDC 70594-057?
- 70594-057 is the product NDC for Vancomycin, Vancomycin 1.25 g/250mL injection, solution, listed with the FDA by Xellia Pharmaceuticals USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vancomycin.
- What is the active ingredient?
- Vancomycin.
- Who is the labeler?
- Xellia Pharmaceuticals USA LLC, NDC labeler code 70594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vancomycin?
- 8 other product NDCs are listed under this name. See all Vancomycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vancomycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vancomycin | Vancomycin 750 mg/150mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-056 | 70594-0056-0270594-0056-03 |
| Vancomycin | Vancomycin 1.75 g/350mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-058 | 70594-0058-02 |
| Vancomycin | Vancomycin 500 mg/100mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-041 | 70594-0041-0270594-0041-03 |
| Vancomycin | Vancomycin 1 g/200mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-042 | 70594-0042-0270594-0042-03 |
| Vancomycin | Vancomycin 1.5 g/300mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-043 | 70594-0043-02 |
| Vancomycin | Vancomycin 2 g/400mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-044 | 70594-0044-02 |
| Vancomycinvancomycin hydrochloride | Vancomycin hydrochloride 5 g/100mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-157 | 25021-0157-99 |
| Vancomycinvancomycin hydrochloride | Vancomycin hydrochloride 10 g/100mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-158 | 25021-0158-99 |
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 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 |
| 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 500 mg/100mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9471 |
| Tyzavanvancomycin | Vancomycin 1 g/200mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9472 |
| 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 1.5 g/300mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-043 |
| 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 1.75 g/350mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-058 |