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 |
|---|---|---|---|---|---|---|
| Dr. Talbots Tummy Ache Relief | CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM | Talbot's Pharmaceuticals Family Products, LLC | 91c1e0ae-9999-0ae2-e053-2995a90a2d71 | 2021-10-05 | Warnings | 660YQ98I10 |
| Solucion InterSol | SOLUCION ADITIVA PARA PLAQUETAS 3 | Fenwal, Inc. | d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1 | 2021-10-04 | Warnings, Adverse reactions | GR686LBA74 451W47IQ8X |
| KALI MURIATICUM | KALI MURIATICUM | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | b70cbfef-2c00-4e13-aa88-c411c5261230 | 2021-09-29 | Warnings | 660YQ98I10 |
| NATRUM MURIATICUM | NATRUM MURIATICUM | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 520edb18-5f2a-4448-ba53-83408a839e1f | 2021-09-02 | Warnings | 451W47IQ8X |
| Lactated Ringers Irrigation | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE | B. Braun Medical Inc. | 0db56c7a-2b8f-4593-8591-2c481c92b2cf | 2021-08-06 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Sodium Chloride for Irrigation | SODIUM CHLORIDE FOR IRRIGATION | B. Braun Medical Inc. | 5bd9b176-0402-4a3f-a6b4-c3f393fc092a | 2021-08-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride | POTASSIUM CHLORIDE | Guardian Drug Company | 3d460e84-27a0-485c-8b11-58d03d9064aa | 2021-07-28 | Warnings, Adverse reactions | 660YQ98I10 |
| 0.9% SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c755e41b-acba-7234-e053-2995a90aff0f | 2021-07-17 | Warnings, Adverse reactions | 451W47IQ8X |
| FERRUM PHOSPHORICUM 6X | HYDRATED IRON III PHOSPHATE | Seroyal USA | 14f4f926-0742-12cd-e054-00144ff8d46c | 2021-07-14 | Warnings | 4J9FJ0HL51 |
| Melange combination | CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA | Seroyal USA | 0a071fbf-0075-4479-e054-00144ff8d46c | 2021-07-14 | Warnings | 451W47IQ8X 660YQ98I10 |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 4a655cde-283f-4ec8-a3d9-5f539c55c204 | 2021-05-10 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride | POTASSIUM CHLORIDE | Aurobindo Pharma Limited | deb6b462-397f-4527-ae26-40dc5d5857bc | 2021-04-30 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Aurobindo Pharma Limited | d43beabe-b801-4319-ad36-9a80856b94bd | 2021-04-29 | Warnings, Adverse reactions | 660YQ98I10 |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ed8fd0c1-ac42-4267-877e-ceadf3831c90 | 2021-04-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Dr. Talbots Vital 12 | CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC | Talbot's Pharmaceuticals Family Products, LLC | c10bb804-8169-63da-e053-2a95a90a8306 | 2021-04-28 | Warnings | 451W47IQ8X 660YQ98I10 |
| Dr. Talbots Infant Daily Allergy Relief | ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC | c0963200-67dd-6349-e053-2a95a90adde1 | 2021-04-22 | Warnings | 451W47IQ8X |
| CLINIMIX E | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE | Baxter Healthcare Company | 8469d6fb-d6ef-476f-8cc3-0905192de0a8 | 2021-04-13 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Medical Purchasing Solutions, LLC | c3f8e83c-4fb9-91da-e053-2a95a90abd63 | 2021-04-12 | Adverse reactions | 451W47IQ8X |
| CVS Health Sterile Saline Mist Live Better | SODIUM CHLORIDE | CVS Pharmacy | ccc3ab8c-b22f-420d-869b-f2a65b8c7180 | 2021-03-13 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | aeaed9cb-b629-4019-88d2-a916179427de | 2021-02-19 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.