Vancomycin Hydrochloride
- Product NDC
- 63323-295
- 11-digit product format
- 633230295
- Labeler code
- 63323
- Product ID
- 63323-295_020618ad-8f1f-4189-a95c-254f05a077cc
- 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
- 2001-07-17
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 5 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 | 5 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 |
|---|
| 63323-295-61 | Vancomycin Hydrochloride | 100 mL in 1 BOTTLE | INJECTION, POWDER, LYOPHILIZED, | 100 | | 7 |
| 63323-295-61 | Vancomycin Hydrochloride | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 63323-295-66 | Vancomycin Hydrochloride | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 63323-295-66 | Vancomycin Hydrochloride | 100 mL in 1 BOTTLE | INJECTION, POWDER, LYOPHILIZED, | 100 | | 6 |
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 [FRESENIUS KABI USA, LLC] | 1 | |
| VANCOMYCIN HYDROCHLORIDE | ACTIVE INGREDIENT | 71WO621TJD | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| VANCOMYCIN | ACTIVE MOIETY | 6Q205EH1VU | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| VANCOMYCIN | ACTIVE MOIETY | 6Q205EH1VU | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-295 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC, 2 package rows | 20211007_d3147f2d-1a72-4923-874b-8fdee2be625e.zip |
| 63323-295 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 6 | Current NDC, Legacy NDC, 2 package rows | 20230316_0713a847-a334-4b73-af22-343aa06621b9.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 |
|---|
| 63323-295-61 | 63323029561 | 1 BOTTLE in 1 CARTON (63323-295-61) / 100 mL in 1 BOTTLE | 1 bottle | 2001-07-17 | 0000-00-00 | No | No | Current |
| 63323-295-66 | 63323029566 | 1 BOTTLE in 1 CARTON (63323-295-66) / 100 mL in 1 BOTTLE | 1 bottle | 2001-07-17 | 0000-00-00 | No | No | Current |