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 |
|---|---|---|---|---|---|---|
| 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 |
| Potassium Chloride | POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE | Fresenius Kabi USA, LLC | 55d9ae37-4553-47e7-a2e3-86b48b5227cd | 2024-05-08 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | f0cc6713-4d47-49be-8116-901c99002b6b | 2024-05-07 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 7f22c06b-6b4d-4b49-a4b2-d2169f2bd653 | 2024-05-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | Asclemed USA, Inc. | f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff | 2024-05-07 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | 97001218-086c-430a-9e0d-6c7031c91d94 | 2024-05-06 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | fe5b5182-c859-4c74-b2e0-467be5b2e329 | 2024-05-06 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | f2475fa3-ab1d-4b81-8127-b58cd0790a54 | 2024-05-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Weed Grass Antigens | ALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS, | Energique, Inc. | 8a28f56a-6010-42e3-b360-e6e22b86222a | 2024-05-02 | Warnings | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | c2467d57-cd2d-4409-bcc0-50128bd01bba | 2024-04-30 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Mineffect eye drops | ALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM | Kadesh Incoporation Co,Ltd | e2259f58-3043-4af3-918d-d4403757aa1f | 2024-04-26 | Warnings | 451W47IQ8X |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Fresenius Kabi USA, LLC | 7a723a23-3bc1-4f69-b82f-d06a35dc68d6 | 2024-04-24 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | c1e52670-c85e-4f19-a2e9-bf9abd7c3727 | 2024-04-23 | Warnings, Adverse reactions | 451W47IQ8X |
| Dermapar | EPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUM | Energique, Inc. | f79fe29b-341e-4bee-9665-1805a7157d1a | 2024-04-22 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Hikma Pharmaceuticals USA Inc. | e5ee8caa-b6ca-45ba-98fb-8305e6282141 | 2024-04-10 | Adverse reactions | 451W47IQ8X |
| Hers Plus | CALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALIS | Deseret Biologicals,Inc. | e4636b80-f6c8-459c-8d0e-ff7801358b10 | 2024-04-09 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.