NDC 64406-035-01 - ELOCTATE
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
- 64406-035
- Requested NDC
- 64406-035-01
- Package NDCs from labels
- 64406-035-01
- Manufacturer
- Biogen Inc.
- Effective date
- 2020-08-04
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| ELOCTATE - Biogen Inc. | Biogen Inc. | 2020-08-04 | PLASMA DERIVATIVE |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| (1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT) | ACTIVE INGREDIENT | 7PCM518YLR | ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.] | 2 | |
| (1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT) | ACTIVE MOIETY | 7PCM518YLR | ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.] | 2 | |
| calcium chloride | INACTIVE INGREDIENT | M4I0D6VV5M | ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.] | 2 | |
| Histidine | INACTIVE INGREDIENT | 4QD397987E | ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.] | 2 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.] | 2 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.] | 2 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.] | 2 |
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 |
|---|---|---|---|---|---|---|
| Distress-Mood-Sadness | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 98d08917-2f1b-4dc7-e053-2a95a90a1ce0 | 2020-12-02 | Warnings | 451W47IQ8X |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9aefc830-329c-5e35-e053-2a95a90a6ffe | 2020-11-30 | Warnings | C151H8M554 451W47IQ8X |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9af2d6f4-baa8-5da9-e053-2995a90a3dac | 2020-11-30 | Warnings | C151H8M554 451W47IQ8X |
| Fatigue Fighter | ACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA. | Newton Laboratories, Inc. | 9aa3c692-fbe0-debe-e053-2995a90add50 | 2020-11-25 | Warnings | 451W47IQ8X |
| Fatigue Fighter | ACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA. | Newton Laboratories, Inc. | 9ab1c9ba-a90e-7f55-e053-2a95a90a9451 | 2020-11-25 | Warnings | 451W47IQ8X |
| Feminine Comfort | AGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELIS | Newton Laboratories, Inc. | 9ab4520d-1dd3-7b9f-e053-2a95a90a274f | 2020-11-25 | Warnings | 451W47IQ8X |
| Blues - Mood - Emotions | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 79890e75-dfac-0262-e053-2a91aa0a5ce5 | 2020-11-24 | Warnings | 451W47IQ8X |
| Blues - Mood - Emotions | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 798ab5a2-7464-8e9d-e053-2a91aa0acc98 | 2020-11-24 | Warnings | 451W47IQ8X |
| Cold Hands - Feet | HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA | Newton Laboratories, Inc. | 7a2b4f28-2128-a8b2-e053-2a91aa0a2402 | 2020-11-24 | Warnings | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | Asclemed USA, Inc. | afac6cc5-1ced-4639-b6f6-86f40ef5c30e | 2020-10-29 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| GUNA ALLERGY | ADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA - | Guna spa | ae6bd80d-2c70-1a3f-e053-2a95a90a2652 | 2020-10-23 | Warnings | 451W47IQ8X |
| InterSol | PLATELET ADDITIVE 3 | Fenwal, Inc. | a00c4a93-cde2-4753-81f7-0d6fee9fb690 | 2020-10-20 | Warnings, Adverse reactions | 451W47IQ8X |
| Travasol | LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE | Baxter Healthcare Corporation | 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 2020-10-07 | Warnings, Adverse reactions | 4QD397987E |
| SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ac0fd44a-3f39-8d7e-e053-2995a90afeec | 2020-08-04 | Warnings, Adverse reactions | 451W47IQ8X |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| Cardioplegic | CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE | Baxter Healthcare Corporation | 1fd50ce5-2799-4c26-81da-02cf0578dd9e | 2020-06-11 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a62b71db-8ba2-6f6b-e053-2a95a90a29d1 | 2020-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| LACTATED RINGERS AND DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | HF Acquisition Co LLC, DBA HealthFirst | a62cf623-9b8a-37e0-e053-2995a90add5b | 2020-05-21 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.