Vancomycin Hydrochloride
- Product NDC
- 68083-143
- 11-digit product format
- 680830143
- Labeler code
- 68083
- Product ID
- 68083-143_35615711-767c-4182-b290-cb1b86d20524
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA205694
- Marketing category
- ANDA
- Marketing start
- 2016-02-23
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 500 mg/10mL
- 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 | 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 |
|---|
| 68083-143-25 | Vancomycin Hydrochloride | 25 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 25 | | 10 |
| 68083-143-25 | Vancomycin Hydrochloride | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-143 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20220224_00946db3-d6c5-4534-a870-1ec6e63eda43.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 |
|---|
| 68083-143-25 | 68083014325 | 25 VIAL in 1 CARTON (68083-143-25) / 10 mL in 1 VIAL | 25 vial | 2016-02-23 | 0000-00-00 | No | No | Current |