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 |
|---|---|---|---|---|---|---|
| Potassium Chloride | POTASSIUM CHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 542e16b0-44db-490f-b44e-4c88a6e3d8b8 | 2025-09-17 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Strides Pharma Science Limited | 0224e5b3-3c49-4e6e-aa78-1abcc6969246 | 2025-09-17 | Warnings, Adverse reactions | 660YQ98I10 |
| Saline Laxative | SALINE LAXATIVE | Major Pharmaceuticals | b3758ffe-1bac-4df6-9714-5e33e9d28d90 | 2025-09-16 | Warnings | GR686LBA74 |
| Perikabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | c2eb5522-8572-45f4-869d-42f9fd251bb6 | 2025-09-15 | Warnings, Adverse reactions | 660YQ98I10 |
| Kabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | afeb4837-a759-4484-a76e-e04611c459e7 | 2025-09-11 | Warnings, Adverse reactions | 660YQ98I10 |
| GAVILYTE-N | POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE | Lupin Pharmaceuticals,Inc. | 27195187-75a3-431f-90d9-84da1b94e849 | 2025-09-10 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| GaviLyte - C TM | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK | Lupin Pharmaceuticals,Inc. | a8b15625-ca7c-4d57-9f36-3ac2a6d13665 | 2025-09-10 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| GAVILYTE G TM | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | Lupin Pharmaceuticals,Inc. | 3978822b-6473-4072-9f80-20ceb9bea355 | 2025-09-10 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Potassium Chloride Extended-release | POTASSIUM CHLORIDE EXTENDED-RELEASE | Preferred Pharmaceuticals Inc. | 87f369cf-40e5-4f91-aa42-ae986fce6544 | 2025-09-10 | Warnings, Adverse reactions | 660YQ98I10 |
| Schuessler Tissue Salts Comb 12 General Tonic | CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA | Martin & Pleasance Pty Ltd | 9083a01b-2fbe-4e04-9eec-bf4f65950ec7 | 2025-09-09 | Warnings | 451W47IQ8X 660YQ98I10 |
| Schuessler Tissue Salts Comb 12 General Tonic | CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA | Martin & Pleasance Pty Ltd | c14c79ab-85bb-45f2-83d1-1d9c298ffdfd | 2025-09-08 | Warnings | 451W47IQ8X 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Major Pharmaceuticals | 7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a4 | 2025-09-05 | Warnings, Adverse reactions | 660YQ98I10 |
| Polyethylene Glycol 3350 and electrolytes - Unflavored | POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED | Strides Pharma Science Limited | 48c741a9-9039-4fdb-a875-86d4ea968282 | 2025-09-05 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3dfa63fc-f8de-f1e0-e063-6294a90a8d47 | 2025-09-04 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3dfac7ca-2c2e-e709-e063-6394a90adbb3 | 2025-09-04 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | Kesin Pharma Corporation | 440dcbbb-bb31-d3fd-e063-6294a90ab2f7 | 2025-09-01 | Warnings, Adverse reactions | 660YQ98I10 |
| Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED | Strides Pharma Science Limited | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 2025-09-01 | Warnings, Adverse reactions | 451W47IQ8X 660YQ98I10 |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES IN SODIUM CHLORIDE | Amneal Pharmaceuticals LLC | dce22c93-aa48-48a9-ac8b-716400d33c9e | 2025-09-01 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 8f6ea056-5e10-4de1-97f0-55f0655a6f78 | 2025-08-27 | Warnings, Adverse reactions | 660YQ98I10 |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 8757d093-747b-4e97-af6d-4064b16178b2 | 2025-08-27 | Warnings, Adverse reactions | 660YQ98I10 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.