Prescription drug · ANDA
Vancomycin Hydrochloride NDC 68083-595
Vancomycin hydrochloride 750 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-595-10 | 68083059510 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-595-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-595-01)Marketed from Mar 21, 2025 |
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 Hydrochloride
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Active ingredients
- Vancomycin hydrochloride — 750 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218140
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 68083-595_16f3240c-d1ce-4407-ad09-565915a13805SPL ID 16f3240c-d1ce-4407-ad09-565915a13805SPL set ID 65e5f2ee-934c-40d7-967c-00d085f84ffdRxCUI 1807518, 2049888, 2049890UNII 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
N468083059510followed by a unit qualifier and the quantityPackage 68083-0595-10. 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 Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates 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 Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for 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 Hydrochloride for Injection…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218140
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 1.5 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-479 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 750 mg/15mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-147 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-596 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-597 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/25mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-148 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-149 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-478 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 750 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-477 |