VANCOMYCIN HYDROCHLORIDE
- Product NDC
- 63323-203
- 11-digit product format
- 633230203
- Labeler code
- 63323
- Product ID
- 63323-203_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VANCOMYCIN HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA062663
- Marketing category
- ANDA
- Marketing start
- 2016-08-17
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 750 mg/15mL
- 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 | 750 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 71WO621TJD |
| Rxcui | 1807513, 1807516, 1807518 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-203-01 | VANCOMYCIN HYDROCHLORIDE | 15 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 15 | | 17 |
| 63323-203-20 | VANCOMYCIN HYDROCHLORIDE | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 17 |
| 63323-203-26 | Vancomycin Hydrochloride | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
| 63323-203-41 | Vancomycin Hydrochloride | 15 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 15 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VANCOMYCIN HYDROCHLORIDE | ACTIVE INGREDIENT | 71WO621TJD | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 3 | |
| VANCOMYCIN | ACTIVE MOIETY | 6Q205EH1VU | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-203 | VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 16 | Current NDC, Legacy NDC, 2 package rows | 20240328_f604d399-fded-4f4f-8efe-af558ed07b9d.zip |
| 63323-203 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250501_9bfe30f8-c662-4af3-bc82-f0102eef8952.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 |
|---|
| 63323-203-01 | 63323020301 | 15 mL in 1 VIAL | 15 ml | | | | | Historical |
| 63323-203-20 | 63323020320 | 10 VIAL in 1 TRAY (63323-203-20) / 15 mL in 1 VIAL (63323-203-01) | 10 vial | 2016-08-17 | 0000-00-00 | No | No | Current |
| 63323-203-26 | 63323020326 | 10 VIAL in 1 TRAY (63323-203-26) / 15 mL in 1 VIAL (63323-203-41) | 10 vial | 2016-08-17 | 0000-00-00 | No | No | Current |
| 63323-203-41 | 63323020341 | 15 mL in 1 VIAL | 15 ml | | | | | Historical |