Vancomycin Hydrochloride
- Product NDC
- 0409-3515
- 11-digit product format
- 004093515
- Labeler code
- 0409
- Product ID
- 0409-3515_10032a19-0373-4c42-b785-f3d915614e30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VANCOMYCIN HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA062912
- Marketing category
- ANDA
- Marketing start
- 2021-05-28
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 1.5 g/1
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vancomycin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VANCOMYCIN HYDROCHLORIDE | 1.5 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 71WO621TJD |
| Rxcui | 1807513, 1807516, 1807518, 2049890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-3515-01 | Vancomycin Hydrochloride | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 37 |
| 0409-3515-11 | Vancomycin Hydrochloride | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 37 |
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 [HOSPIRA, INC.] | 17 | |
| VANCOMYCIN | ACTIVE MOIETY | 6Q205EH1VU | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 17 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 17 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 17 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-3515 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 36 | Current NDC, Legacy NDC, 2 package rows | 20250109_f2901045-904f-47bd-74a1-c561facd7f25.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 |
|---|
| 0409-3515-01 | 00409351501 | 10 VIAL in 1 TRAY (0409-3515-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0409-3515-11) | 10 vial | 2021-05-28 | 0000-00-00 | No | No | Current |
| 0409-3515-11 | 00409351511 | 1 in 1 VIAL | | | | | | Historical |