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 |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Civica, Inc. | 3f49eedf-5bf5-4a95-b704-c956d860ca04 | 2023-04-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Treprostinil | TREPROSTINIL | Sandoz Inc | 473297ca-a872-4052-a053-87dc8f0d3c13 | 2023-04-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Glutenstat | ALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTEN | Energique, Inc. | c6b867b6-74d9-4725-90d7-7d5d1fe61121 | 2023-04-05 | Warnings | 451W47IQ8X |
| Anxiety | BORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTII | Nutritional Specialties, Inc. | 657ed32f-3ac7-4806-96b4-4c7aa0f65e7f | 2023-04-03 | Warnings | 451W47IQ8X |
| Virility Liquescence | AVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIA | Nutritional Specialties, Inc. | 81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f | 2023-03-29 | Warnings | 451W47IQ8X |
| Spleen Thymus Liquescence | CINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUS | Nutritional Specialties, Inc. | bc1cc31e-0e8a-49a2-9654-f00eaa72fc04 | 2023-03-24 | Warnings | 451W47IQ8X |
| NOVOLOG | INSULIN ASPART | Novo Nordisk | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 2023-02-28 | Warnings, Adverse reactions | 059QF0KO0R |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 1ef4a040-7bee-11e6-8371-424c58303031 | 2023-02-20 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8645e304-a71b-5cba-e053-2a91aa0a2d88 | 2023-02-20 | 451W47IQ8X | |
| EyeClear Pro | CALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEA | Silver Star Brands | f4d4943b-cb78-aa71-e053-2a95a90ac638 | 2023-02-16 | Warnings | 451W47IQ8X |
| CellTropin | ARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUS | Micro Balance Health Products LLC | 502d3ffa-bbf4-403a-9fad-b6b229f36a8c | 2023-02-14 | Warnings | 94ZLA3W45F |
| POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | Novel Laboratories, Inc. | 29d821ff-389c-41fb-8a27-89bd3f022b82 | 2023-02-08 | Warnings, Adverse reactions | 451W47IQ8X |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 86463b98-58f5-7f65-e053-2a91aa0ad3a2 | 2023-01-23 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8645f130-6a19-ae73-e053-2991aa0ab05b | 2023-01-23 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8645eb60-65d1-9d6c-e053-2991aa0a94ef | 2023-01-23 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8644ffef-f0e6-5c06-e053-2a91aa0ae83d | 2023-01-23 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 86466614-b8ee-2335-e053-2a91aa0aa67c | 2023-01-23 | 451W47IQ8X | |
| Rehydrate | AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN | ParaDocs All Natural, Inc. | 648fab10-c46b-420f-a42c-6642009d83fb | 2023-01-10 | Warnings | 059QF0KO0R |
| PSORIASIS | ARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUM | Zorex International | b5b8bb82-4d36-4faa-b023-e48066f4521c | 2023-01-09 | Warnings | 451W47IQ8X |
| Virimmune | ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2021-2022), MORBILLINUM | Deseret Biologicals, Inc. | 56555cb5-89e5-4a30-8ebe-ce2c01bdd426 | 2023-01-03 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.