Vancomycin Hydrochloride
- Product NDC
- 68083-597
- 11-digit product format
- 680830597
- Labeler code
- 68083
- Product ID
- 68083-597_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
- 1.5 g/1
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68083-597_16f3240c-d1ce-4407-ad09-565915a13805
- SPL ID
- 16f3240c-d1ce-4407-ad09-565915a13805
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Vancomycin Hydrochloride
- Generic name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing start
- 2025-03-21
- Marketing category
- ANDA
- Application number
- ANDA218140
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC]; Glycopeptides [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| VANCOMYCIN HYDROCHLORIDE | 1.5 g/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 71WO621TJD |
| Rxcui | 1807518, 2049888, 2049890 |
| Spl Set Id | 65e5f2ee-934c-40d7-967c-00d085f84ffd |
| Manufacturer Name | Gland Pharma Limited |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68083-597-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-597-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-597-01) | 2025-03-21 | No |
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 |
|---|
| 68083-597-10 | 68083059710 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-597-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-597-01) | 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 |