Prescription drug · NDA
Vancomycin Hydrochloride NDC 0338-3580
Vancomycin hydrochloride 750 mg/150mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-3580-48 | 0033835804800338358048 | 200 mL in 1 BAG (0338-3580-48)Marketed from Nov 14, 1958 |
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)
- Vancomycin Hydrochloride
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Active ingredients
- Vancomycin hydrochloride — 750 mg/150mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050671
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 0338-3580_0a2ebd45-cef7-4454-95fd-059663d43203SPL ID 0a2ebd45-cef7-4454-95fd-059663d43203SPL set ID 99e523d8-9bde-43cb-8434-497015e5dcbdRxCUI 1807508, 1807510, 1807511, 2118448, 2387078UNII 71WO621TJD
- 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
N400338358048followed by a unit qualifier and the quantityPackage 00338-3580-48. 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)
Vancomycin Injection is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients 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 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 bacteria. ( 1.6 ) 1.1 Septicemia Vancomycin Injection is …
Excerpt only. Read the full label for complete information.
About NDC 0338-3580
- What is NDC 0338-3580?
- 0338-3580 is the product NDC for Vancomycin Hydrochloride, Vancomycin hydrochloride 750 mg/150mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vancomycin Hydrochloride.
- What is the active ingredient?
- Vancomycin hydrochloride.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 0338. 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 Hydrochloride?
- 128 other product NDCs are listed under this name. See all Vancomycin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vancomycin Hydrochloride 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 Hydrochloride | Vancomycin hydrochloride 5 g/100mL | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-957 | 68462-0957-05 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 10 g/100mL | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-958 | 68462-0958-10 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 750 mg/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-114 | 83634-0114-20 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-115 | 83634-0115-30 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-116 | 83634-0116-30 |
| vancomycin hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-967 | 23155-0967-2523155-0967-78 |
| vancomycin hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-968 | 23155-0968-2523155-0968-78 |
| vancomycin hydrochloride | — | Kit | Aurobindo Pharma Limited | 59651-669 | 59651-0669-0359651-0669-55 |
| vancomycin hydrochloride | — | Kit | Aurobindo Pharma Limited | 59651-670 | 59651-0670-0359651-0670-55 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | PAI Holdings, LLC dba PAI Pharma | 0121-1032 | 00121-1032-2000121-1032-50 |
Other NDCs under NDA 050671
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 |
|---|---|---|---|---|
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/250mL | Injection, SolutionIntravitreal | Baxter Healthcare Corporation | 0338-0122 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/300mL | Injection, SolutionIntravitreal | Baxter Healthcare Corporation | 0338-0124 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 500 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-3551 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1 g/200mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-3552 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 500 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-3581 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 750 mg/150mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-3582 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1 g/200mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-3583 |