Vancomycin Hydrochloride
- Product NDC
- 0143-9356
- 11-digit product format
- 001439356
- Labeler code
- 0143
- Product ID
- 0143-9356_431d7445-e798-40a7-a8aa-6a8b1ac5813f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA203300
- Marketing category
- ANDA
- Marketing start
- 2020-08-11
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- 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 | 500 mg/1 |
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 |
|---|
| 0143-9356-01 | Vancomycin Hydrochloride | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 0143-9356-25 | Vancomycin Hydrochloride | 25 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9356 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210605_2f5d3131-8ddc-43a5-91f7-947c531796e7.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 |
|---|
| 0143-9356-01 | 00143935601 | 1 in 1 VIAL | | | | | | Historical |
| 0143-9356-25 | 00143935625 | 25 VIAL in 1 CARTON (0143-9356-25) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9356-01) | 25 vial | 2020-08-11 | 0000-00-00 | No | No | Current |