Vancomycin Hydrochloride
- Product NDC
- 45932-0028
- 11-digit product format
- 459320028
- Labeler code
- 45932
- Product ID
- 45932-0028_f678483a-285a-4880-acb8-d934a4cf5d43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Xellia Pharmaceuticals, ApS
- Application
- ANDA091377
- Marketing category
- ANDA
- Marketing start
- 2014-04-10
- Marketing end
- 0000-00-00
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 45932-0028-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d106-f424-e053-dadaa90a57ce | VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 45932-0028-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d106-f424-e053-dadaa90a57ce | VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45932-0028-1 | Vancomycin Hydrochloride | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 45932-0028-2 | Vancomycin Hydrochloride | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45932-0028 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS, APS] | 4 | Legacy NDC, 2 package rows | 20151231_0cb43ce8-f462-42b1-b73b-370bb7931c23.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 45932-0028-1 | 45932002801 | 1 in 1 CARTON | Historical |
| 45932-0028-2 | 45932002802 | 10 in 1 CARTON | Historical |