Vancomycin Hydrochloride
- Product NDC
- 68083-570
- 11-digit product format
- 680830570
- Labeler code
- 68083
- Product ID
- 68083-570_c45949e7-eaef-4e97-8a8e-9134855ee6a4
- 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
- 2023-06-06
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 10 g/100mL
- 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/100mL |
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 |
|---|
| 68083-570-01 | Vancomycin Hydrochloride | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 68083-570-01 | Vancomycin Hydrochloride | 100 mL in 1 BOTTLE | INJECTION, POWDER, LYOPHILIZED, | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-570 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 3 | Current NDC, 2 package rows | 20230714_35ecffbc-77d8-4c0d-9b14-6a3cc442dec6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-570-01 | 68083057001 | 1 BOTTLE in 1 CARTON (68083-570-01) / 100 mL in 1 BOTTLE | 1 bottle | 2023-06-06 | No | No | Historical |