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 |
|---|---|---|---|---|---|---|
| PTS/Stress Remedy | KALI PHOSPHORICUM, AMBRA GRISEA, CACAO, PHOSPHORICUM ACIDUM, ARNICA MONTANA, CALCAREA CARBONICA, CEREBRUM SUIS, GLANDULA SUPRARENALIS SUIS, LITHIUM CARBONICUM, ACONITUM NAPELLUS, ARGEMONE MEXICANA, ARSENICUM ALBUM, CICUTA VIROSA, HYOSCYAMUS NIGER, IGNATIA TIGRINUM, NATRUM MURIATICUM, TARENTULA HISPANICA, STRAMONIUM, BUTHUS AUSTRALIS | Deseret Biologicals, Inc. | 05341147-789a-4844-9412-6a3044e5eb18 | 2024-03-04 | Warnings | 451W47IQ8X |
| EPST PLUS | CARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLA | Deseret Biologicals, Inc. | c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc25 | 2024-02-27 | Warnings | 451W47IQ8X |
| Bladder Relief | CAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS | The Magni Company | b09bf037-703f-4c22-8535-b33d586ebefa | 2024-02-08 | Warnings | 451W47IQ8X |
| Potassium Chloride | POTASSIUM CHLORIDE | Proficient Rx LP | 61daa681-05a0-4b2f-a6d0-c6fc1044f521 | 2024-02-01 | Warnings, Adverse reactions | 660YQ98I10 |
| Ear Ringing | ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA | Newton Laboratories, Inc. | 1043debe-8787-a2f5-e063-6294a90a2a66 | 2024-01-31 | Warnings | 660YQ98I10 |
| Ear Ringing | ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA | Newton Laboratories, Inc. | 1045ab27-c4d5-fcbd-e063-6294a90a5176 | 2024-01-31 | Warnings | 660YQ98I10 |
| Tinnitus | ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA | Newton Laboratories, Inc. | 10462aaa-96d4-4ba3-e063-6294a90a7915 | 2024-01-31 | Warnings | 660YQ98I10 |
| Natrum Muriaticum | SODIUM CHLORIDE | SEVENE USA | 11008014-fff6-4d5a-8c5c-a20443d7cc23 | 2024-01-30 | Warnings | 451W47IQ8X |
| Potassium Chloride | POTASSIUM CHLORIDE | Lupin Pharmaceuticals,Inc. | fe08221d-74d5-490a-8db4-eaf3ed20b289 | 2024-01-30 | Warnings, Adverse reactions | 660YQ98I10 |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a14ca7d9-de30-a303-e053-2a95a90a5304 | 2024-01-27 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | e5247ed5-6170-c13f-e053-2a95a90a4101 | 2024-01-27 | Warnings, Adverse reactions | 451W47IQ8X |
| BSS | BALANCED SALT SOLUTION | Alcon Laboratories, Inc. | 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea | 2024-01-25 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| CIRCULATION HP | ARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, LACHESIS MUTUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA, | Energique, Inc. | 464d208b-3893-4ec6-9868-12ef6807b98d | 2024-01-23 | Warnings | 451W47IQ8X |
| DERMA SCALE HP | ARSENICUM IODATUM, BORAX, GRAPHITES, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PETROLEUM, SEPIA, SULPHUR | Energique, Inc. | 64961787-7e9a-4e6f-98ce-0f51934155cf | 2024-01-23 | Warnings | 451W47IQ8X |
| Potassium Chloride | POTASSIUM CHLORIDE | American Health Packaging | a67f5ba7-ac23-4bdc-9563-cb7fd049a951 | 2024-01-22 | Warnings, Adverse reactions | 660YQ98I10 |
| Energy Complex | ECHINACEA (ANGUSTIFOLIA), LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOX, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE) | Health Masters LLC | 9286ca29-8190-4867-9231-b0d68180cb10 | 2024-01-22 | Warnings | 451W47IQ8X |
| Lung Drainage | KALI MURIATICUM, CARBO VEGETABILIS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, PNEUMOCOCCINUM, OXYGENIUM, ANTIMONIUM ARSENICICUM, CAMPHORA, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, IPECACUANHA, LOBELIA PURPURESCENS, PHOSPHORUS, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDE | Deseret Biologicals, Inc. | 8fdb37fb-f3df-4dae-abb4-1f3a71c1c683 | 2024-01-15 | Warnings | 660YQ98I10 |
| Sodium Chloride | SODIUM CHLORIDE | Spectra Medical Deviecs, LLC | 7e316d21-d6ad-4976-bd90-268fd7e51361 | 2024-01-12 | Adverse reactions | 451W47IQ8X |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Sun Pharmaceutical Industries, Inc. | 4d90d03d-7f0e-4d49-9e80-628dbc7165c0 | 2024-01-10 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Sun Pharmaceutical Industries, Inc. | 8ed8ea55-8b15-f718-e053-2a95a90a587a | 2024-01-10 | Warnings, Adverse reactions | 660YQ98I10 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.