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 | Gland Pharma Limited | 65e5f2ee-934c-40d7-967c-00d085f84ffd | 2025-04-24 | Warnings, Adverse reactions | 1807518 71WO621TJD |
| vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 33127951-1fad-15c1-e063-6294a90a6996 | 2025-04-18 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b62b7190-48e8-4596-a6ad-9ad455e5c8c6 | 2025-03-21 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | 9bfe30f8-c662-4af3-bc82-f0102eef8952 | 2025-03-17 | Warnings, Adverse reactions | ANDA062663 63323-203 1807518 8270ac4f-3c40-4db1-8083-bebced4fee14 9bfe30f8-c662-4af3-bc82-f0102eef8952 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | 91c050cf-3b2d-48bc-7297-e8dc68225e5a | 2025-01-16 | Warnings, Adverse reactions | 71WO621TJD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | 83ea3faf-fedd-4725-911f-d71a23ec5d5e | 2024-10-15 | Warnings, Adverse reactions | ANDA062663 63323-284-21 63323-284 1807513 f9a5db80-2985-406e-a7b8-5593e3e8696e 83ea3faf-fedd-4725-911f-d71a23ec5d5e 71WO621TJD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC. | e4ce7b87-fab4-4b7a-b121-eba136c464ce | 2024-08-07 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin | VANCOMYCIN HYDROCHLORIDE | Sagent Pharmaceuticals | 06dcfd36-942f-4752-86ad-4c5a6fc3e48f | 2024-07-19 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Eugia US LLC | 4a80cb3f-7410-47aa-af1f-ff83d1b35c55 | 2024-07-08 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Eugia US LLC | 78984781-3c0b-4b73-ba85-10d60ecb2a28 | 2024-07-08 | Warnings, Adverse reactions | 1807513 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | 40a88420-5fcb-4715-abc5-595a18fd08d0 | 2024-06-07 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Mylan Institutional LLC | caf22ccb-df75-45ea-a1d0-ccb2d37272fb | 2024-06-07 | Warnings, Adverse reactions | 1807518 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Xellia Pharmaceuticals USA LLC | 8403695c-3614-490b-9797-6c5ebcdeef9b | 2023-12-12 | Warnings, Adverse reactions | 1807513 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | 45642a47-4712-4a12-8cf7-ee6c2ab8e6c6 | 2023-09-29 | Warnings, Adverse reactions | 71WO621TJD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | 0576803d-95de-4a48-806a-69ae3fcaf6b0 | 2023-08-17 | Warnings, Adverse reactions | ANDA062663 63323-221-41 63323-284-26 63323-221-16 63323-284-42 63323-221 63323-284 1807513 1807516 7b9b7963-befb-46bd-8357-a61be3d0ba9e 0576803d-95de-4a48-806a-69ae3fcaf6b0 71WO621TJD |
| Vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Eugia US LLC | 9aa42538-c84e-4886-8d3d-a7dfded5120f | 2023-08-05 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Gland Pharma Limited | 35ecffbc-77d8-4c0d-9b14-6a3cc442dec6 | 2023-07-13 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Sagent Pharmaceuticals | 4843726f-6e79-6e20-2620-4a54616e6479 | 2023-06-29 | Warnings, Adverse reactions | 1807513 1807516 71WO621TJD |
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 3c47d5c4-8cdb-4701-8d7a-8a6e79025b53 | 2023-06-23 | Warnings, Adverse reactions | 71WO621TJD |
| Vancomycin hydrochloride | VANCOMYCIN HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | e5e26614-4119-40cc-b092-48ab97a41287 | 2023-03-27 | Warnings, Adverse reactions | 1807518 71WO621TJD |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.