NDC 68516-1002 - Alphanate
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
- 68516-1002
- Package NDCs from labels
- 68516-1002-2
- Manufacturer
- GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | Grifols Therapeutics LLC
- Effective date
- 2026-08-25
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Alphanate - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | Grifols Therapeutics LLC | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | Grifols Therapeutics LLC | 2026-08-25 | PLASMA DERIVATIVE |
| Factor IX Complex Profilnine ® | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2026-04-01 | PLASMA DERIVATIVE |
| dextrose - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2025-05-27 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-1002-2 | Profilnine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 33 |
| 68516-1002-2 | Profilnine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 33 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-1002 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip |
| 68516-1002 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip |
| 68516-1002 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 24 | Unmatched | 20240123_3e99052d-4442-4283-8915-c9a796c77008.zip |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| HAIR STIM | PEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINOR | The Wellness Center for Research and Education, Inc. | 8ecc05ff-ed5a-4157-9100-1c7912686f07 | 2025-06-06 | Warnings | 451W47IQ8X |
| MBM 7 Lung | COCCUS CACTI, LUNG (SUIS), IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUM | The Wellness Center for Research and Education, Inc. | 6eb49fb5-485c-4b48-b231-4db88ebe20df | 2025-06-04 | Warnings | 451W47IQ8X |
| PRISMASOL BGK2/0 | MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE | Vantive US Healthcare LLC | 7f675fee-8940-4ece-bb0c-75ac79d8708c | 2025-05-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Henry Schein, Inc. | 88403fcf-a276-42c0-88b6-bd84a720b564 | 2025-05-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Resentment | ADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALE | Deseret Biologicals, Inc. | d397ed9c-10f0-4a99-baca-a31e5e18572a | 2025-05-27 | Warnings | 451W47IQ8X |
| Virimmune | ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2023-2024), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUM | Deseret Biologicals, Inc. | 1d35a8ab-c06b-478d-8f7b-dbe9c7dbb3d4 | 2025-05-27 | Warnings | 451W47IQ8X |
| Insecticides/Pest/Food Additives Detox | BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Dr. Donna Restivo DC | b5778211-0e3e-44ef-bd65-a76a68cf1504 | 2025-05-23 | Warnings | 1Q73Q2JULR |
| MetDetox | ALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, | Dr. Donna Restivo DC | 89ce5e89-c592-445e-92f9-365133005fb3 | 2025-05-23 | Warnings | 451W47IQ8X |
| Virex | ASCLEPIAS TUBEROSA, ECHINACEA PURPUREA, TRIFOLIUM PRATENSE, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, EUPHRASIA OFFICINALIS, LAC VACCINUM (NSPC), THUJA OCCIDENTALIS, CALCAREA ARSENICICA, CAMPHORA, INFLUENZINUM, CYTOMEGALOVIRUS NOSODE, MORBILLINUM, VARIOLINUM, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B5 NOSODE, COXSACKIE A5 NOSODE, ADENOVIREN NOSODE, EPSTEIN BARR VIRUS NOSODE, COXSACKIE B4 NOSODE | Nutritional Specialties, Inc. | a37728d6-2428-42f7-b331-c07cdc4e9956 | 2025-05-21 | Warnings | 451W47IQ8X |
| Adrenal Tonic | ARALIA QUINQUEFOLIA, GLYCYRRHIZA GLABRA, SARSAPARILLA, AVENA SATIVA, GLANDULA SUPRARENALIS BOVINE, ADRENALINUM, ARSENICUM ALBUM, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, VERATRUM ALBUM | BioActive Nutritional, Inc. | 2bbf65e2-47b9-46d3-a8de-69bc543783f8 | 2025-05-20 | Warnings | 451W47IQ8X |
| Saline 1.5 FL OZ | SALINE | ALAINA HEALTHCARE PRIVATE LIMITED | f1bdbb25-6943-4828-9ae0-7d9783c18b5f | 2025-05-19 | Warnings | 451W47IQ8X |
| Lymph II | ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA | BioActive Nutritional, Inc. | 678874d0-7600-4d03-ad1e-e4dc67157597 | 2025-05-16 | Warnings | 451W47IQ8X |
| Eyesaline Emergency Eyewash | STERILE EYESALINE EYEWASH | Honeywell Safety Products USA, Inc. | 2d567518-4c54-7448-e063-6294a90a3e64 | 2025-05-14 | Warnings | 059QF0KO0R |
| DIANEAL LOW CALCIUM WITH DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | 67bee807-7ba8-4e92-81f2-c888118d277e | 2025-05-09 | 451W47IQ8X | |
| DIANEAL LOW CALCIUM WITH DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | 0fb30b7e-8e1b-49c7-afac-2d5c01b9ff45 | 2025-05-09 | 451W47IQ8X | |
| DIANEAL LOW CALCIUM WITH DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | b0f2c9a2-d9d4-4907-a324-e7a26d489f44 | 2025-05-09 | 451W47IQ8X | |
| DIANEAL LOW CALCIUM WITH DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | a829d4eb-3ec5-453c-b270-793969af15b3 | 2025-05-09 | 451W47IQ8X | |
| EXTRANEAL | ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Vantive US Healthcare LLC | 5bf31b49-24c8-4021-98da-33a151f2fcbe | 2025-05-08 | 451W47IQ8X | |
| DIANEAL LOW CALCIUM WITH DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | 50fc30a0-0eca-452e-825e-08c2647ccfc1 | 2025-05-08 | 451W47IQ8X | |
| Shame | ADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 090e4a23-3e1b-4b0c-a0cc-0172b05f7b64 | 2025-05-07 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.