Vancomycin Hydrochloride
- Product NDC
- 45932-0031
- 11-digit product format
- 459320031
- Labeler code
- 45932
- Product ID
- 45932-0031_ed462f6b-158d-4b97-92d0-8b91bef31132
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Xellia Pharmaceuticals ApS
- Application
- ANDA206243
- Marketing category
- ANDA
- Marketing start
- 2015-02-10
- Marketing end
- 0000-00-00
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 5 g/100mL
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 45932-0031 | | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 45932-0031 | 45932-0031-1 | I | Inactivated by FDA | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A206243-001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | | | 2015-12-23 |
| A206243-002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | | | 2015-12-23 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45932-0031-1 | Vancomycin Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 45932-0031-1 | Vancomycin Hydrochloride | 100 mL in 1 BOTTLE | INJECTION | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45932-0031 | VANCOMYCIN HYDROCHLORIDE INJECTION [XELLIA PHARMACEUTICALS APS] | 4 | Legacy NDC, 2 package rows | 20160204_75a6a873-21b9-4f48-89a9-c1476294c0ce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 45932-0031-1 | 45932003101 | 1 in 1 CARTON | Historical |