NDC 58468-0357-03 - 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
- 58468-0357-03
- Package NDCs from labels
- 58468-0357-1, 58468-0357-3, 58468-0357-03
- 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 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 |
| 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 |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 9d5dea47-5103-21a3-e053-2995a90aee78 | 2024-05-20 | Warnings | 451W47IQ8X |
| Colopar | COLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALIS | Energique, Inc. | c47d7203-abcd-4ae5-bf9b-5df07e07d3c1 | 2024-05-20 | Warnings | 451W47IQ8X |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Camber Pharmaceuticals, Inc. | b1e827aa-b2fb-4fa5-984d-ddd94338ff53 | 2024-05-14 | Warnings, Adverse reactions | 660YQ98I10 |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | 4510fe59-cc28-4585-925f-42508a60abd0 | 2024-05-13 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 47a0313f-36df-4fa6-a828-c9e1946ba9b0 | 2024-05-08 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.