NDC 63323-284-01 - 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
- 63323-284
- Requested NDC
- 63323-284-01
- Package NDCs from labels
- 63323-284-01, 63323-284-20, 63323-284-21, 63323-284-42, 63323-284-26, 63323-284-41, 63323-284-45
- 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 | 2024-10-15 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-284-01 | VANCOMYCIN HYDROCHLORIDE | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | 17 | |
| 63323-284-20 | VANCOMYCIN HYDROCHLORIDE | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | 17 | |
| 63323-284-26 | VANCOMYCIN HYDROCHLORIDE | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | 8 | |
| 63323-284-42 | VANCOMYCIN HYDROCHLORIDE | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | 8 | |
| 63323-284-41 | Vancomycin Hydrochloride | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | 5 | |
| 63323-284-45 | Vancomycin Hydrochloride | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | 5 | |
| 63323-284-21 | VANCOMYCIN HYDROCHLORIDE | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | 3 | |
| 63323-284-21 | VANCOMYCIN HYDROCHLORIDE | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-284 | 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 |
| 63323-284 | 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 |
| 63323-284 | 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 |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241019_83ea3faf-fedd-4725-911f-d71a23ec5d5e.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-284-01 | EA - Each | 63323-284 | 4f14b5a3-79c4-48b7-bdf2-b9ce378d63df | 1 | 2021-07-15 |
| 63323-284-20 | EA - Each | 63323-284 | d35e820f-cbba-476d-9ea6-28b08a919919 | 1 | 2013-02-13 |
| 63323-284-21 | EA - Each | 63323-284 | 868b29d1-7274-437c-adbf-b05628fe92f8 | 1 | 2016-02-04 |
| 63323-284-26 | EA - Each | 63323-284 | 6688da60-5b9e-42a8-82e1-794deca75a69 | 1 | 2015-09-10 |
| 63323-284-41 | EA - Each | 63323-284 | 9ca01873-7d4f-4799-8623-83f2ae99d4e0 | 1 | 2018-02-20 |
| 63323-284-42 | EA - Each | 63323-284 | dd09a04e-3c86-47d9-905a-8e7268e8f776 | 1 | 2021-11-09 |
| 63323-284-45 | EA - Each | 63323-284 | a59758c0-c0c7-4af4-9b4e-7245d83a2c91 | 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 | Hospira, Inc. | f2901045-904f-47bd-74a1-c561facd7f25 | 2026-04-01 | Warnings, Adverse reactions | 1807513 1807518 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | c9ea31ec-4c26-452f-b07b-c5f894212cd5 | 2026-04-01 | Warnings, Adverse reactions | 1807513 1807516 71WO621TJD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | ae6efaaf-37eb-4510-ba71-5f3dc3abdbd3 | 2026-03-31 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Plano Pharmaceuticals Inc. | 4983e3c8-e0f2-b366-e063-6394a90a9557 | 2026-03-25 | Warnings, Adverse reactions | 1807513 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 27d06545-1af0-4dcd-926d-58d4a9492ec3 | 2026-03-02 | Warnings, Adverse reactions | 71WO621TJD |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 3707ad2e-5c82-4111-a370-e518e5e7e4c5 | 2026-03-02 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Plano Pharmaceuticals Inc. | 4983f60c-0f7b-d427-e063-6394a90a838c | 2026-02-24 | Warnings, Adverse reactions | 71WO621TJD |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ab658fbd-68ea-4275-84b1-c3361c860bd3 | 2026-02-11 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Gland Pharma Limited | 00946db3-d6c5-4534-a870-1ec6e63eda43 | 2026-01-30 | Warnings, Adverse reactions | 1807513 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | XGen Pharmaceuticals DJB, Inc. | 4239165c-4c15-b78e-e063-6294a90ae6af | 2025-12-31 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC., USA | 0543b2b5-b1c7-4ad6-b38c-3be0086f0e06 | 2025-12-23 | Warnings, Adverse reactions | 1807518 71WO621TJD |
| Vancocin | VANCOMYCIN HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | a078d9c2-f89c-4f9f-8ded-60ffb2983c3f | 2025-12-22 | Warnings, Adverse reactions | 71WO621TJD |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Redpharm Drug | 3745b502-c222-e307-e063-6394a90a697e | 2025-12-18 | Warnings, Adverse reactions | 71WO621TJD |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Strides Pharma Science Limited | fac438bd-e08f-438d-ab64-426fc5c5450e | 2025-11-28 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Henry Schein, Inc. | 1bda7fa4-fdee-410a-a216-02cfbf91632f | 2025-11-07 | Warnings, Adverse reactions | 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 2025-10-31 | Warnings, Adverse reactions | 1807518 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Civica, Inc | 50e4fb19-f603-439c-b193-25a455115383 | 2025-10-13 | Warnings, Adverse reactions | 71WO621TJD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC. | 8eccafe8-40c9-495a-872d-7f45a98ee759 | 2025-08-13 | Warnings, Adverse reactions | 1807513 1807518 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Sagent Pharmaceuticals | f623889c-a47a-4b3a-b3a9-e04051f5c2df | 2025-05-28 | Warnings, Adverse reactions | 1807518 71WO621TJD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | f604d399-fded-4f4f-8efe-af558ed07b9d | 2025-05-15 | Warnings, Adverse reactions | ANDA062663 63323-221-10 63323-203-20 63323-221-01 63323-203-01 63323-284-01 63323-284-20 63323-221 63323-284 63323-203 63323028401 1807513 1807518 1807516 570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5 f604d399-fded-4f4f-8efe-af558ed07b9d 71WO621TJD |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.