Vancomycin Hydrochloride
- Product NDC
- 67457-339
- 11-digit product format
- 674570339
- Labeler code
- 67457
- Product ID
- 67457-339_7f3b7523-139d-40e8-986a-0c88447941bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA065397
- Marketing category
- ANDA
- Marketing start
- 2013-12-05
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 500 mg/10mL
- 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 | 500 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 71WO621TJD |
| Rxcui | 1807513, 1807516 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-339-00 | Vancomycin Hydrochloride | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 9 |
| 67457-339-50 | Vancomycin Hydrochloride | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VANCOMYCIN HYDROCHLORIDE | ACTIVE INGREDIENT | 71WO621TJD | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 2 | |
| VANCOMYCIN | ACTIVE MOIETY | 6Q205EH1VU | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-339 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230219_2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-339-00 | 67457033900 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 67457-339-50 | 67457033950 | 10 VIAL in 1 CARTON (67457-339-50) / 10 mL in 1 VIAL (67457-339-00) | 10 vial | 2013-12-05 | 0000-00-00 | No | No | Current |