Vancomycin hydrochloride
- Product NDC
- 55150-472
- 11-digit product format
- 551500472
- Labeler code
- 55150
- Product ID
- 55150-472_9aa42538-c84e-4886-8d3d-a7dfded5120f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA217401
- Marketing category
- ANDA
- Marketing start
- 2023-08-04
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 1.5 g/30mL
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vancomycin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VANCOMYCIN HYDROCHLORIDE | 1.5 g/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 71WO621TJD |
| Rxcui | 2049888, 2049890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-472-10 | Vancomycin hydrochloride | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 1 |
| 55150-472-10 | Vancomycin hydrochloride | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-472 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 1 | Current NDC, 2 package rows | 20230808_9aa42538-c84e-4886-8d3d-a7dfded5120f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-472-10 | 55150047210 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-472-10) / 30 mL in 1 VIAL, SINGLE-DOSE | 2023-08-04 | No | No | Current |