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 |
|---|---|---|---|---|---|---|
| Hay Fever | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS | Newton Laboratories, Inc. | a6045b91-d361-2731-e053-2a95a90a9772 | 2020-05-18 | Warnings | 451W47IQ8X |
| Isolyte S | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 2020-05-14 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| DEXTROSE AND SODIUM CHLORIDE | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE | Fresenius Kabi USA, LLC | b825c9c4-f2fb-4a4a-9d8c-fb020ad07e93 | 2020-04-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride | POTASSIUM CHLORIDE | Genus Lifesciences Inc. | 23d818e7-c076-40de-8dc1-0b51ba4be96a | 2020-04-28 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Lupin Pharmaceuticals,Inc. | 1bbacdbb-91fa-4897-a00c-1b293de27b83 | 2020-04-27 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Mylan Pharmaceuticals Inc. | c64ed4c0-1e27-42b3-9625-fb4e0d31e271 | 2020-04-15 | Warnings, Adverse reactions | 660YQ98I10 |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2b8220f-e33a-51c3-e053-2995a90a0734 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2bba76a-08ce-6902-e053-2995a90ab9c9 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Electrolyte No. 48 | SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Company | b283a454-0c20-4fbf-92d3-dae1f3cd3cad | 2020-02-13 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 4J9FJ0HL51 |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | fbc01464-8885-4075-af41-911ffec5ae92 | 2020-01-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Plasma-Lyte A | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | 6ec9e61c-2c26-402f-8604-f446b2e34058 | 2019-08-05 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Potassium Chloride in Dextrose | POTASSIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Company | 45de5402-5e61-4bbd-8bbc-5e3392c9920e | 2019-07-15 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | BluePoint Laboratories | 431ff2ef-567c-4b60-af43-f4da61febaad | 2019-07-03 | Warnings, Adverse reactions | 660YQ98I10 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE EXTENDED-RELEASE | Solco Healthcare LLC | f704b746-ab75-4484-8704-5baa94a07750 | 2019-04-30 | Warnings, Adverse reactions | 660YQ98I10 |
| Tinnitus Relief | CINCHONA OFFICINALIS BARK,SALICYLIC ACID,QUININE SULFATE,FERRUM PHOSPHORICUM,POTASSIUM CHLORIDE,CALOMEL,ALLYLTHIOUREA,. | Homeocare Laboratories | 30d67273-b9ec-4f3e-ace6-87a68325aaf1 | 2019-02-28 | Warnings | 660YQ98I10 |
| Potassium Chloride in Dextrose and Sodium Chloride | POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Baxter Healthcare Company | c553fed1-3de5-4826-8eff-633b5923bf0b | 2019-02-21 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Potassium Chloride in Sodium Chloride | POTASSIUM CHLORIDE AND SODIUM CHLORIDE | Baxter Healthcare Company | becc7410-0a25-49f5-b0c3-240078479dc8 | 2019-01-11 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Skin Klear Acne Relief | TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR | Homeocare Laboratories | 65afbc20-611b-4bc4-a151-c633bec66a82 | 2018-12-31 | Warnings | 451W47IQ8X |
| FREDS SALINE TWIN PACK LAXATIVE | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | FRED'S | 7d15057f-eb3b-477f-ab14-68c3c38ea910 | 2018-12-26 | Warnings | GR686LBA74 |
| H.M.D. | ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM | Zorex International | 8c53091a-904d-4756-93e4-17143c5b48e9 | 2018-12-21 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.