Prescription drug · ANDA
Vancomycin Hydrochloride NDC 39822-0460
Vancomycin hydrochloride 1.25 g/1 · Injection, Powder, Lyophilized, For solution · Intravenous · XGen Pharmaceuticals DJB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39822-0460-2 | 39822046002 | 10 VIAL in 1 CARTON (39822-0460-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Dec 15, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1.25 g/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215324
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 39822-0460_4743ac39-0730-0f3d-e063-6394a90a8fc5SPL ID 4743ac39-0730-0f3d-e063-6394a90a8fc5SPL set ID 4239165c-4c15-b78e-e063-6294a90ae6afRxCUI 2049888, 2049890UNII 71WO621TJDUPC 0339822047024, 0339822047017, 0339822046027, 0339822046010
- 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
N439822046002followed by a unit qualifier and the quantityPackage 39822-0460-02. 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 .
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 215324
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/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 82449-005 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 82449-006 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 82449-007 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | XGen Pharmaceuticals DJB, Inc. | 39822-0470 |