Prescription drug · ANDA
Vancomycin Hydrochloride NDC 68462-477
Vancomycin hydrochloride 750 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · GLENMARK PHARMACEUTICALS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-477-74 | 6846204777468462047774 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68462-477-74) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68462-477-20)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
- GLENMARK PHARMACEUTICALS INC., USANDC labeler code 68462
- 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 68462-477_210eb04c-a542-44da-b4a3-7e243186b483SPL ID 210eb04c-a542-44da-b4a3-7e243186b483SPL set ID 0543b2b5-b1c7-4ad6-b38c-3be0086f0e06RxCUI 1807518, 2049888, 2049890UNII 71WO621TJDUPC 0368462478844, 0368462477748, 0368462479841
- 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
N468462047774followed by a unit qualifier and the quantityPackage 68462-0477-74. 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…
Excerpt only. Read the full label for complete information.
About NDC 68462-477
- What is NDC 68462-477?
- 68462-477 is the product NDC for Vancomycin Hydrochloride, Vancomycin hydrochloride 750 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by GLENMARK PHARMACEUTICALS INC., USA. 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?
- GLENMARK PHARMACEUTICALS INC., USA, NDC labeler code 68462. 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?
- 140 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 10 g/100mL | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-958 | 68462-0958-10 |
| 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 1.25 g/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-115 | 83634-0115-30 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 750 mg/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-114 | 83634-0114-20 |
| 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 250 mg/1 | CapsuleOral | PAI Holdings, LLC dba PAI Pharma | 0121-1033 | 00121-1033-2000121-1033-50 |
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 750 mg/15mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-147 |
| 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 750 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-595 |
| 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/1 | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-478 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-479 |