Vancomycin Hydrochloride
- Product NDC
- 68083-595
- 11-digit product format
- 680830595
- Labeler code
- 68083
- Product ID
- 68083-595_16f3240c-d1ce-4407-ad09-565915a13805
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218140
- Marketing category
- ANDA
- Marketing start
- 2025-03-21
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 71WO621TJD | VANCOMYCIN HYDROCHLORIDE | 1404-93-9 | VANCOMYCIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 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) | 2025-03-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Vancomycin Hydrochloride | Gland Pharma Limited | 2025-04-24 | Human Prescription Drug Label | 4 |