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 |
|---|---|---|---|---|---|---|
| Rhustoxoforce | APIS MELLIFICA, CANTHARIS, GRAPHITES, NATRUM MURIATICUM, RHUS GLABRA, RHUS TOXICODENDRON, RHUS VENENATA, URTICA DIOICA | BioActive Nutritional, Inc. | 5a3627f1-a850-42f3-8c7a-b2067bd03538 | 2024-10-18 | Warnings | 451W47IQ8X |
| Strength M | ARALIA QUINQUEFOLIA, AVENA SATIVA, DAMIANA, EPIMEDIUM GRANDIFLORUM, GLUTATHIONE, L-ARGININE, L-LEUCINE, L-ORNITHINE, L-VALINE, TESTOSTERONE, SABAL SERRULATA, SEPIA | BioActive Nutritional, Inc. | 8eda49aa-da6c-4e06-926c-73f35f33e5d8 | 2024-10-18 | Warnings | 94ZLA3W45F |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Becton Dickinson and Company | bb2ad9cd-5d9a-4337-be61-0842d738c79e | 2024-10-16 | Warnings, Adverse reactions | 451W47IQ8X |
| Elliotts B | SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE | Lukare Medical, LLC | 08036dbd-55b3-47b9-9890-000f253544f3 | 2024-10-16 | Warnings, Adverse reactions | 451W47IQ8X SE337SVY37 |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Fresenius Kabi USA, LLC | 8fce1477-991f-4b43-bf05-a80bad897262 | 2024-10-16 | Warnings, Adverse reactions | 451W47IQ8X |
| EyS Eye Wash | WATER | Eyes-Plus LLC | 1443f6bf-3a77-4a19-8585-0ec58efe042f | 2024-10-15 | Warnings | 059QF0KO0R |
| Eye Wash | WATER SOLUTION | Kroger Company | 354402ad-581d-47e7-9fd3-933bef281ff4 | 2024-10-11 | Warnings | 059QF0KO0R |
| Eye Wash | WATER | Hubei Changjian Medical Products Co., Ltd. | d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea | 2024-10-11 | Warnings | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | c44b0fdb-33df-4747-b443-5fb4deb456cb | 2024-10-11 | Warnings, Adverse reactions | 451W47IQ8X |
| Bacteriostatic Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | e5e325d1-0d58-40c9-9645-3ae402ff9d92 | 2024-10-11 | Warnings, Adverse reactions | 451W47IQ8X |
| Vamousse Lice Defense | EUCALYPTUS GLOBULUS, NATRUM MURIATICUM | Alliance Pharma Inc. | c87ce5d3-c200-421e-88be-bc8060a5993a | 2024-10-08 | Warnings | 451W47IQ8X |
| Energy Catalyst | VISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS, POTASSIUM ASPARTATE, SODIUM MOLYBDATE, ADENOSINUM, CYCLOPHOSPHORICUM, CERIUM OXALICUM, NICKEL ACETATE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, ALUMINA, | Deseret Biologicals, Inc. | 99529dd4-f8ab-4348-8b65-dc8c89e1ad54 | 2024-10-04 | Warnings | 451W47IQ8X |
| Thyroid HP | BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, LAPIS ALBUS, LEVOTHYROXINUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SELENIUM METALLICUM, SPONGIA TOSTA, THYROIDINUM (SUIS) | Energique, Inc. | 2f04e425-7160-41a7-aa1e-934db54f1751 | 2024-09-30 | Warnings | 451W47IQ8X |
| Gut Brain Spectrum | ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM | Energique, Inc. | cb1566a4-92d4-4f1a-9211-f0c538a83c27 | 2024-09-27 | Warnings | 451W47IQ8X |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | cc3d5bc8-9d3c-4c65-9e43-707a2db4081a | 2024-09-25 | Warnings | 451W47IQ8X |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 93fafa27-5031-4d95-b4b8-5574b7204ae2 | 2024-09-25 | Warnings | 451W47IQ8X |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 454f337e-d897-46de-ab05-1c543a33061c | 2024-09-25 | Warnings | 451W47IQ8X |
| Defense | PETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR (BOVINE), MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (OVINE), SACCHARINUM | Nutritional Specialties, Inc. | ddd879cf-1a85-4b8d-bdb0-5cf495fea4e6 | 2024-09-24 | Warnings | 451W47IQ8X |
| HP Axis | ARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONE | Deseret Biologicals, Inc. | 402f5b05-c71e-4dba-bc2b-049aee42952a | 2024-09-23 | Warnings | 451W47IQ8X |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 3c5f0f65-8a54-4a55-ad4e-0f0be97631d7 | 2024-09-15 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.