NDC 63323-221-01 - VANCOMYCIN HYDROCHLORIDE
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 63323-221
- Requested NDC
- 63323-221-01
- Package NDCs from labels
- 63323-221-01, 63323-221-10, 63323-221-41, 63323-221-16, 63323-221-33, 63323-221-38, 63323-221-43, 63323-221-48
- Manufacturer
- Fresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITED
- Effective date
- 2025-05-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE - Fresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITED | Fresenius Kabi USA, LLC | Xellia Pharmaceuticals ApS | GLAND PHARMA LIMITED | 2025-05-15 | HUMAN PRESCRIPTION DRUG LABEL |
| VANCOMYCIN HYDROCHLORIDE - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2023-08-17 | HUMAN PRESCRIPTION DRUG LABEL |
| Vancomycin Hydrochloride - Fresenius Kabi, LLC | Xellia Pharmaceuticals ApS | Fresenius Kabi, LLC | Xellia Pharmaceuticals ApS | 2022-12-02 | HUMAN PRESCRIPTION DRUG LABEL |
| Vancomycin Hydrochloride - Fresenius Kabi, LLC | Xellia Pharmaceuticals ApS | Fresenius Kabi, LLC | Xellia Pharmaceuticals ApS | 2022-12-02 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-221-01 | VANCOMYCIN HYDROCHLORIDE | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | 17 | |
| 63323-221-10 | VANCOMYCIN HYDROCHLORIDE | 25 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 25 | 17 | |
| 63323-221-16 | VANCOMYCIN HYDROCHLORIDE | 25 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 25 | 8 | |
| 63323-221-41 | VANCOMYCIN HYDROCHLORIDE | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | 8 | |
| 63323-221-33 | Vancomycin Hydrochloride | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | 6 | |
| 63323-221-38 | Vancomycin Hydrochloride | 25 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 25 | 6 | |
| 63323-221-43 | Vancomycin Hydrochloride | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | 5 | |
| 63323-221-48 | Vancomycin Hydrochloride | 25 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 25 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-221 | 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 |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240404_0576803d-95de-4a48-806a-69ae3fcaf6b0.zip |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20221209_8a35ebee-8650-4ef5-84f5-ab9b55d9bc19.zip |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221209_418c3c6a-d08d-448c-89c9-54e558c1ce16.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-221-01 | EA - Each | 63323-221 | 15969898-e93b-4adf-8dce-2f06d66c2267 | 1 | 2021-09-07 |
| 63323-221-10 | EA - Each | 63323-221 | 0ddcdf0d-7ce9-49ba-9418-6dd5b46c8eb4 | 1 | 2013-02-13 |
| 63323-221-16 | EA - Each | 63323-221 | 8c581df8-0ea4-42c0-abec-614b243f00b1 | 1 | 2015-09-10 |
| 63323-221-33 | EA - Each | 63323-221 | 6979b73c-eafe-4cce-b6d7-381e73c08a65 | 1 | 2018-02-20 |
| 63323-221-38 | EA - Each | 63323-221 | d8cf2b75-d900-48f6-ab15-c20587c122cd | 1 | 2018-02-20 |
| 63323-221-41 | EA - Each | 63323-221 | 003fe177-fdac-4efe-939b-a406d24ab7ba | 1 | 2021-09-07 |
| 63323-221-43 | EA - Each | 63323-221 | bfa5d38c-802d-484a-8a56-1ce5a80a90a4 | 1 | 2018-02-20 |
| 63323-221-48 | EA - Each | 63323-221 | d2db232f-1e3e-4f6f-bc35-4a40e4fa2662 | 1 | 2018-02-20 |
DailyMed Socrata Ingredients#
| 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 | |
| VANCOMYCIN HYDROCHLORIDE | ACTIVE INGREDIENT | 71WO621TJD | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| VANCOMYCIN | ACTIVE MOIETY | 6Q205EH1VU | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | 0713a847-a334-4b73-af22-343aa06621b9 | 2023-02-07 | Warnings, Adverse reactions | ANDA062663 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi, LLC | 8a35ebee-8650-4ef5-84f5-ab9b55d9bc19 | 2022-12-02 | Warnings, Adverse reactions | ANDA204107 63323-221-33 63323-221-38 63323-221 1807516 0ab54d7b-de6b-412f-b2b5-a8522f78f3c4 8a35ebee-8650-4ef5-84f5-ab9b55d9bc19 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi, LLC | 418c3c6a-d08d-448c-89c9-54e558c1ce16 | 2022-12-02 | Warnings, Adverse reactions | ANDA204107 63323-284-41 63323-221-43 63323-284-45 63323-221-48 63323-221 63323-284 1807513 1807516 23a89459-d331-4975-84fe-4bfa6ed2c24e 418c3c6a-d08d-448c-89c9-54e558c1ce16 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | BluePoint Laboratories | f28e3c2b-ae31-4c2a-8178-53962b7b213c | 2022-09-22 | Warnings, Adverse reactions | 71WO621TJD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 3f5dacea-af40-4103-b128-c5e0c0c52fa1 | 2022-07-20 | Warnings, Adverse reactions | 1807513 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 86950e7c-0114-47e9-8891-e09e595c48c3 | 2022-02-25 | Warnings, Adverse reactions | 1807518 |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | cae9e5f3-b89a-4a7f-93f7-9471c74a3559 | 2021-12-07 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | d3147f2d-1a72-4923-874b-8fdee2be625e | 2021-09-30 | Warnings, Adverse reactions | ANDA062663 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | ce139a51-0471-4c31-b456-2f889f18dd2b | 2021-09-15 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 2f5d3131-8ddc-43a5-91f7-947c531796e7 | 2021-06-02 | Warnings, Adverse reactions | 1807513 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | 2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf | 2021-06-01 | Warnings, Adverse reactions | 1807513 1807516 71WO621TJD |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | 3843d0d7-f70a-4b29-9478-dfb45b02425e | 2021-06-01 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | SAMSON MEDICAL TECHNOLOGIES LLC | 93589e71-3a11-4797-9176-8abdb7674a87 | 2020-11-29 | Boxed warning, Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi, LLC | a7e7d990-1d74-459b-ac07-d1c3e13b3204 | 2019-01-09 | Warnings, Adverse reactions | 71WO621TJD |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.