NDC 68516-1001 - 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
- 68516-1001
- Package NDCs from labels
- 68516-1001-1
- 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-1001-1 | Profilnine | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 33 |
| 68516-1001-1 | Alphanate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 26 |
| 68516-1001-1 | Alphanate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 26 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-1001 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip |
| 68516-1001 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.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 |
|---|---|---|---|---|---|---|
| Body Balance | ARALIA QUIN, ARNICA, AVENA, CARDUUS MAR, ELAEIS, GLANDULA SUPRARENALIS SUIS, NAT MUR, PHOSPHORICUM AC, THUJA OCC | Eight and Company L.L.C | 876cc0cf-c7a7-4656-adf9-1eff9bb62687 | 2025-12-18 | Warnings | 451W47IQ8X |
| ADRENOPLEX | CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS BOVINE, SPLEEN (SUIS), CARDUUS MARIANUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM | BioActive Nutritional, Inc. | 3c53c23e-7654-4e46-acf1-edb0d605ff3b | 2025-12-18 | Warnings | 451W47IQ8X |
| Vermasode | ARTEMISIA VULGARIS, CHELIDONIUM MAJUS, GRANATUM, SPIGELIA ANTHELMIA, RATANHIA, ARSENICUM ALBUM, FERRUM METALLICUM, CALCAREA CARBONICA, CINA, GAERTNER BACILLUS, GRAPHITES, MERCURIUS DULCIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, VERMIN NOSODE | Natural Creations, Inc | 180b5641-5692-42d4-8472-fdadccebd746 | 2025-12-18 | Warnings | 451W47IQ8X |
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM | Energetix Corporation | 9b532a31-530a-44f9-843f-f395a3e460b8 | 2025-12-17 | Warnings | 451W47IQ8X |
| Equate Yeast Relief | CANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFUR | WAL-MART STORES INC | d96aa608-ed8a-36cd-e053-2a95a90ac286 | 2025-12-17 | Warnings | 451W47IQ8X |
| OP-P | EMOTIONAL HEALTH BOOSTER | Vitality Works, Inc. | a8b87a49-fc73-4494-8dc9-059bc5f82d42 | 2025-12-17 | Warnings | 451W47IQ8X |
| Vital-FL | BODY FLUID BALANCE | Vitaltiy Works, Inc. | 13207197-7ef7-49a3-8970-5f98299a75d2 | 2025-12-17 | Warnings | 451W47IQ8X |
| Woman Power | AGNUS, ARALIA QUIN, ARNICA, DAMIANA, LACTUCA, NAT MUR, ONOSMODIUM VIRGINIANUM, OOPHORINUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SALIX NIG, SEPIA, THUJA OCC | Eight and Company L.L.C | 614d47de-742b-4944-89c8-59f2f58dc8b9 | 2025-12-17 | Warnings | 451W47IQ8X |
| STERILE CORD BLOOD COLLECTION UNIT (MSC123D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE | Maco Productions | e3b456ec-4578-485f-a696-8a343505f30b | 2025-12-16 | Warnings | 1Q73Q2JULR |
| PSORIASIS HP | ARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUM | Natural Creations, Inc. | d2522637-fd16-4246-90d8-f90fb224550e | 2025-12-16 | Warnings | 451W47IQ8X |
| Mood | ARALIA QUIN, CIMICIFUGA, SPIGELIA ANTH, ARG NIT, ARSENICUM ALB, AURUM MET, IGNATIA AMARA, LACHESIS, LYCOPODIUM, NAT MUR, PHOSPHORICUM AC, PLATINUM MET, PULSATILLA, SEPIA, THUJA OCC | Natural Creations, Inc | 7f143f30-2b72-4e6c-985c-8d3a485dbdb4 | 2025-12-16 | Warnings | 451W47IQ8X |
| IODIUM HP | BARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, FUCUS VESICULOSUS, IODINE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED, THYROID | Natural Creations, Inc. | 9353d604-e168-4df1-9726-e965c9fc2c78 | 2025-12-16 | Warnings | 451W47IQ8X |
| SINUS HP | AMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG | Natural Creations, Inc. | f017da22-74c2-40f4-adcc-5e84b6ea5291 | 2025-12-16 | Warnings | 451W47IQ8X |
| Hydrate 1 | BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGEN | Natural Creations, Inc | 189bc53c-5d75-48df-a74e-cfff2d08d3a9 | 2025-12-16 | Warnings | 451W47IQ8X |
| Hydrate 2 | BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA | Natural Creations, Inc | 1122605f-715e-4f12-9d9d-a20442f9cd45 | 2025-12-16 | Warnings | 451W47IQ8X |
| Migraine Headache Therapy | ATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE - | TRP Company | 317d3f42-783e-02b7-e054-00144ff88e88 | 2025-12-15 | Warnings | 451W47IQ8X |
| Mucus and Sinus Mucus and Sinus Symptom Relief | BRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUM | TRP Company | 2a42c4a3-9486-9b29-e063-6294a90a7c70 | 2025-12-15 | Warnings | 451W47IQ8X |
| Natural Relief Cold and Flu Plus Zinc | ALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUM | TRP Company | 2a352cf2-48fb-4862-e063-6294a90a2eeb | 2025-12-15 | Warnings | 451W47IQ8X |
| Natural Relief Cough and Congestion Cough and Congestion Symptom Relief | ANTIMONIUM TARTARICUM, COCCUS CACTI, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM MURIATICUM, RUMEX CRISPUS, ZINCUM GLUCONICUM | TRP Company | 2a430f41-bd33-32af-e063-6394a90ae801 | 2025-12-15 | Warnings | 451W47IQ8X |
| Sinu-Rite | GLYCYRRHIZA, KALI BIC, NAT MUR, PULSATILLA, SAMBUCUS | SILVER STAR BRANDS | b79e177c-6bd7-2f9a-e053-2a95a90abedb | 2025-12-12 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.