Vancomycin Hydrochloride
- Product NDC
- 71288-026
- 11-digit product format
- 712880026
- Labeler code
- 71288
- Product ID
- 71288-026_b7b203d8-dec6-49c3-a147-2cfb5f38cbb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA215196
- Marketing category
- ANDA
- Marketing start
- 2022-07-27
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 10 g/95mL
- 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 | 10 g/95mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 71WO621TJD |
| Rxcui | 239209, 313572 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-026-75 | Vancomycin Hydrochloride | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 71288-026-75 | Vancomycin Hydrochloride | 95 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, POWDER, LYOPHILIZED, | 95 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-026 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231003_45642a47-4712-4a12-8cf7-ee6c2ab8e6c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71288-026-75 | 71288002675 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-026-75) / 95 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2022-07-27 | 0000-00-00 | No | No | Current |