NDC 58468-0357-01 - Campath
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
- 58468-0357
- Requested NDC
- 58468-0357-01
- Package NDCs from labels
- 58468-0357-1, 58468-0357-3, 58468-0357-01
- Manufacturer
- Genzyme Corporation | Boehringer Ingelheim Pharma GmbH & Co. KG | Sanofi-Aventis Deutschland GmbH | HVL Pharma UK Limited
- Effective date
- 2025-11-05
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Campath | Genzyme Corporation | Boehringer Ingelheim Pharma GmbH & Co. KG | Sanofi-Aventis Deutschland GmbH | HVL Pharma UK Limited | 2025-11-05 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58468-0357-1 | Campath | 1 in 1 CARTON | INJECTION | 1 | 21 | |
| 58468-0357-1 | Campath | 1 mL in 1 VIAL, SINGLE-USE | INJECTION | 1 | 21 | |
| 58468-0357-3 | Campath | 1 mL in 1 VIAL, SINGLE-USE | INJECTION | 1 | 21 | |
| 58468-0357-3 | Campath | 3 in 1 CARTON | INJECTION | 3 | 21 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58468-0357 | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 20 | Current NDC, Legacy NDC, 4 package rows | 20241213_4f5f7255-7abc-4328-bd1a-ceaf139ef3e0.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58468-0357-1 | ML - Milliliter | 58468-0357 | b2a94b16-4b9d-43ea-8128-2680117eda26 | 1 | 2012-07-24 |
| 58468-0357-3 | ML - Milliliter | 58468-0357 | 36e3cd9d-b0a3-4d54-9f2b-be56352cb780 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ALEMTUZUMAB | ACTIVE INGREDIENT | 3A189DH42V | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 6 | |
| ALEMTUZUMAB | ACTIVE MOIETY | 3A189DH42V | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 6 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 6 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 6 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 6 | |
| POTASSIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 4J9FJ0HL51 | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 6 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 6 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] | 6 |
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 |
|---|---|---|---|---|---|---|
| Potassium Chloride Extended-release | POTASSIUM CHLORIDE EXTENDED-RELEASE | Bryant Ranch Prepack | 7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb | 2024-07-18 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51 | 2024-07-18 | Warnings, Adverse reactions | 660YQ98I10 |
| sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | 8df7dcf6-8714-6caf-e053-2995a90ab8cc | 2024-07-15 | Warnings, Adverse reactions | 451W47IQ8X |
| WINTER BLEND | ECHINACEA (ANGUSTIFOLIA), UVA-URSI, BAPTISIA TINCTORIA, CONVALLARIA MAJALIS, KALI MURIATICUM, PINUS SYLVESTRIS, THUJA OCCIDENTALIS, BRYONIA, CROTALUS HORRIDUS, LACHESIS MUTUS, SELENIUM METALLICUM, VISCUM ALBUM | Energique, Inc. | ff696389-bad5-463a-be99-e92e86250e86 | 2024-07-12 | Warnings | 660YQ98I10 |
| Potassium Phosphate | POTASSIUM PHOSPHATE | Somerset Therapeutics, LLC | 52f07402-1869-4a97-9c92-9729dc611f85 | 2024-07-11 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| Isolyte P in Dextrose | DEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASIC | B. Braun Medical Inc. | 4ea4397c-2fa4-4670-91e6-21ae498c88f7 | 2024-06-24 | Warnings, Adverse reactions | 660YQ98I10 |
| Sodium Chloride | SODIUM CHLORIDE | CODAN US CORPORATION | aa06e286-75c6-4d7a-959f-6008d38aa6e5 | 2024-06-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Derma Pain Plus | CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII) | Peaceful Mountain, Inc. | 6fa79c31-e48e-4c83-baa2-96cef22cfee1 | 2024-06-13 | Warnings | 451W47IQ8X |
| Cold Sore Rescue | BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA | Peaceful Mountain, Inc. | a7fe6ec7-a758-43cf-b46f-c327e0632fb8 | 2024-06-13 | Warnings | 451W47IQ8X |
| KALI MUR | KALI MUR | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 1a3522bc-3d43-ea96-e063-6394a90aa2cc | 2024-06-06 | Warnings | 660YQ98I10 |
| NATRUM MUR | NATRUM MUR | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 1a22655a-68f3-4f13-e063-6294a90ae52c | 2024-06-05 | Warnings | 451W47IQ8X |
| Potassium Chloride Extended-release | POTASSIUM CHLORIDE EXTENDED-RELEASE | Proficient Rx LP | c53d1db5-1c9e-4289-a2a2-961e0dd56f32 | 2024-06-01 | Warnings, Adverse reactions | 660YQ98I10 |
| Mentox HP | AURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS | Energique, Inc. | ebb23637-4931-4563-ab30-99bea0276580 | 2024-05-28 | Warnings | 451W47IQ8X |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Bryant Ranch Prepack | d396477a-6b15-4782-9c85-b9663b83c484 | 2024-05-23 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride in Lactated Ringers and Dextrose | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE | Fresenius Kabi USA, LLC | dbed53b7-0109-4561-8342-0178ec8c64b0 | 2024-05-22 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | Fresenius Kabi USA, LLC | 1b912c7e-f005-4af4-b683-083440964249 | 2024-05-22 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 239a5af1-7498-480f-862c-ab7c3d89d183 | 2024-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | ebc8b008-a8b3-4c41-89e4-b413f7aab89f | 2024-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | XLCare Pharmaceuticals, Inc. | 7fd82f08-8ad0-4ee2-8eb6-5c973f98baee | 2024-05-21 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 7a220e87-ff72-417b-bc45-90a37b7f2aa6 | 2024-05-21 | Warnings, Adverse reactions | 660YQ98I10 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.