NDC 60505-4791-01 - Cladribine
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
- 60505-4791
- Requested NDC
- 60505-4791-01
- Package NDCs from labels
- 60505-4791-4, 60505-4791-5, 60505-4791-6, 60505-4791-7, 60505-4791-8, 60505-4791-9, 60505-4791-1, 60505-4791-01
- Manufacturer
- Apotex Corp.
- Effective date
- 2026-06-08
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Cladribine - Apotex Corp. | Apotex Corp. | 2026-06-08 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-4791-1 | Cladribine | 10 in 1 CARTON | TABLET | 10 | 3 | |
| 60505-4791-4 | Cladribine | 4 in 1 CARTON | TABLET | 4 | 3 | |
| 60505-4791-5 | Cladribine | 5 in 1 CARTON | TABLET | 5 | 3 | |
| 60505-4791-6 | Cladribine | 6 in 1 CARTON | TABLET | 6 | 3 | |
| 60505-4791-7 | Cladribine | 7 in 1 CARTON | TABLET | 7 | 3 | |
| 60505-4791-8 | Cladribine | 8 in 1 CARTON | TABLET | 8 | 3 | |
| 60505-4791-9 | Cladribine | 9 in 1 CARTON | TABLET | 9 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-4791-1 | EA - Each | 60505-4791 | 212d5c31-e7cf-4f67-a394-219da336a477 | 1 | 2025-12-16 |
| 60505-4791-4 | EA - Each | 60505-4791 | 6423fc1f-af6a-4ccc-b16b-c15bbb29cd9e | 1 | 2025-12-16 |
| 60505-4791-5 | EA - Each | 60505-4791 | 92dfb3c9-4621-4d4d-8de9-dd4618e8321e | 1 | 2025-12-16 |
| 60505-4791-6 | EA - Each | 60505-4791 | 3614f6fc-4468-4975-b3c3-5f8e35dd7d90 | 1 | 2025-12-16 |
| 60505-4791-7 | EA - Each | 60505-4791 | ccbe0e40-8cf0-4854-ac4c-6bf5b7aab56a | 1 | 2025-12-16 |
| 60505-4791-8 | EA - Each | 60505-4791 | b5590580-ccb2-4af3-bcb6-7feb2bd99a25 | 1 | 2025-12-16 |
| 60505-4791-9 | EA - Each | 60505-4791 | efd793c4-1836-4d79-aa1a-9e5e370d4f2b | 1 | 2025-12-16 |
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 |
|---|---|---|---|---|---|---|
| Chemstat | GLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, | Energique, Inc. | 2e361b50-9268-4053-b13c-93af64549848 | 2026-06-25 | Warnings | 506T60A25R |
| Cladribine | CLADRIBINE | Sandoz Inc. | e0b363cb-db83-44d6-89d0-1f7176be7459 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 2122658 2122649 2122647 2122635 2122660 2122654 2122656 2122634 47M74X9YT5 |
| Cladribine | CLADRIBINE | Apotex Corp. | 407c52d5-6498-7da5-da35-acc9ca73ced3 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | ANDA218425 60505-4791-5 60505-4791-4 60505-4791-6 60505-4791-8 60505-4791-9 60505-4791-7 60505-4791-1 60505-4791 60505479101 2122658 2122649 2122647 2122635 2122660 2122654 2122656 2122634 34340d61-039c-2b08-23a6-e3a2389f10a2 407c52d5-6498-7da5-da35-acc9ca73ced3 47M74X9YT5 |
| Mavenclad | CLADRIBINE | EMD Serono, Inc. | 9c75e30a-a410-40f1-b653-04d532bd9144 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 2122658 2122649 2122647 2122635 2122660 2122654 2122656 2122634 47M74X9YT5 |
| Chemstat | GLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM, | Energique, Inc. | 2831d28e-9cf1-4a72-9c6c-bb014d059558 | 2026-05-06 | Warnings | 506T60A25R |
| GeriCare Sorbitol Solution | SORBITOL | GERI-CARE PHARMACEUTICALS, CORP | b4dd7a41-380e-d94b-e053-2a95a90ac34a | 2025-12-31 | Warnings | 506T60A25R |
| Cladribine | CLADRIBINE | Hisun Pharmaceuticals USA, Inc. | 71c39b37-33b5-42e1-bf4f-93ff751cc7fe | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 47M74X9YT5 |
| Hepatatox | TRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUM | BioActive Nutritional, Inc | a113a9f1-4792-41a5-8d1b-a6756f356e15 | 2025-12-18 | Warnings | 506T60A25R |
| Cladribine | CLADRIBINE | Genvion Corporation | f1d650a5-4205-720b-f39b-4213277b6612 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | ANDA218425 2122658 2122649 2122647 2122635 2122660 2122654 2122656 2122634 47M74X9YT5 |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 506T60A25R |
| Plaque identifying | PLAQUE IDENTIFYING | Shenzhen Yagao Technology Co., Ltd. | 37eeb656-22f1-7372-e063-6394a90ad041 | 2025-06-19 | Warnings | 506T60A25R |
| Cladribine | CLADRIBINE | Hisun Pharmaceuticals USA, Inc. | f538cba9-001a-4a21-e053-2a95a90a00ec | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 47M74X9YT5 |
| Chemtox | TRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, | BioActive Nutritional, Inc. | a480e5f4-5f9e-4b23-b257-b0ac1ebfc115 | 2025-01-07 | Warnings | 506T60A25R |
| Chemtox | TRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, | BioActive Nutritional, Inc. | 9aa060f1-f8f6-46e6-a7d0-bd46a73f2676 | 2024-10-17 | Warnings | 506T60A25R |
| Cladribine | CLADRIBINE | Fresenius Kabi USA, LLC | a2592a9b-bca6-4a5a-89c2-855a0634d5fe | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 47M74X9YT5 |
| Chemtox | BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOL | Deseret Biologicals, Inc. | 91f52c95-f36d-4754-8570-f81ed8d36180 | 2024-03-06 | Warnings | 506T60A25R |
| Lipotox | SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, | BioActive Nutritional, Inc. | a1538692-ca00-4e52-9b7e-409767ee27e1 | 2023-09-05 | Warnings | 506T60A25R |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | 506T60A25R |
| Cladribine | CLADRIBINE | Hikma Pharmaceuticals USA Inc. | 5736aecc-cc1d-47dd-86c0-5fb2e9d70f61 | 2023-04-19 | Boxed warning, Warnings, Adverse reactions | 47M74X9YT5 |
| ChemDetox | BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM | Dr. Donna Restivo DC | 2a17f80d-12c0-43a0-980b-9da648e9b76a | 2023-01-10 | Warnings | 506T60A25R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.