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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 7da788fc-3481-527f-e053-2a91aa0af6ac | 2025-01-08 | Adverse reactions | 451W47IQ8X |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | BECTON DICKINSON AND COMPANY | c1d0f42e-3494-4217-8f86-e9f34d930e82 | 2025-01-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Strength F | ALPHA-KETOGLUTARICUM ACIDUM, ISOLEUCINE, L-ARGININE, L CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, ESTRADIOL, FOLLICULINUM, PROGESTERONE, TESTOSTERONE, OOPHORINUM (SUIS) | BioActive Nutritional, Inc. | a4f3a8e7-0a28-4aa0-ba0c-201807d62c96 | 2025-01-03 | Warnings | 94ZLA3W45F |
| Shingles Remedy | CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA | Silver Star Brands | 5d65c997-f5dc-4dee-e053-2a91aa0ac319 | 2025-01-01 | Warnings | 451W47IQ8X |
| Mucus Clear Allergy Relief | ALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICA | Silver Star Brands | f49bdcc1-1939-6dc2-e053-2995a90a0a3b | 2025-01-01 | Warnings | 451W47IQ8X |
| Sweat-Less | ARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MUR | Silver Star Brands | 4053d10b-4b06-291b-e054-00144ff88e88 | 2025-01-01 | Warnings | 451W47IQ8X |
| NativeRemedies Triple Complex Brain Tonic | CALC PHOS, KALI PHOS, NAT MUR. | Silver Star Brands | f76eaf46-4a80-31a9-e053-6394a90a542d | 2025-01-01 | Warnings | 451W47IQ8X |
| Headache Ease | AUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIA | Silver Star Brands | c689fb16-6200-ac94-e053-2995a90a703d | 2025-01-01 | Warnings | 451W47IQ8X |
| AllergiClear-M | ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA | Silver Star Brands | 9d36096b-022f-5cfa-e053-2995a90a381f | 2025-01-01 | Warnings | 451W47IQ8X |
| DG Health Sterile Saline Mist | SODIUM CHLORIDE | DG Health | f2e44ab4-ae0f-c87b-e053-2a95a90acd04 | 2024-12-31 | Warnings | 451W47IQ8X |
| ALBUMINEX | ALBUMIN HUMAN | BPL | 8428d373-f4b1-4e3b-bb19-ea89048f7c79 | 2024-12-31 | Warnings, Adverse reactions | ZIF514RVZR |
| ALBUMINEX | ALBUMIN HUMAN | BPL | 167f48d0-8ae5-4f7e-b050-9673dad78acc | 2024-12-31 | Warnings, Adverse reactions | ZIF514RVZR |
| 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, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM | Energique, Inc. | adfee6ce-05b0-4955-bf5f-9612b8db4c78 | 2024-12-26 | Warnings | 451W47IQ8X |
| TREE ANTIGEN | POPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLE | Natural Creations, Inc | 8040ab36-90eb-4076-a478-9b82ccfa4ec9 | 2024-12-23 | Warnings | 451W47IQ8X |
| Sterile Hypertonic Saline Solution 7 Sodium Chloride | SODIUM CHLORIDE | JOONEM LLC | e7110525-9f9b-5b68-e053-2995a90ac034 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | 49309411-9af4-4f19-a3bf-dbeabc106827 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | ba0868f6-d3de-40e2-bcb3-144fa53062c7 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | 9d83f477-ebbc-4248-8445-769178181d4f | 2024-12-23 | Warnings | 451W47IQ8X |
| Trace Mineral Cord | ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM, | Energique, Inc. | 902dd68d-5ce1-481e-8938-6487dcc68dfc | 2024-12-19 | Warnings | 451W47IQ8X |
| Ancient Secrets Breathe Again | SODIUM CHLORIDE | LOTUS BRANDS, INC. | c6d2bab0-d363-4c09-a71b-ae15db915b37 | 2024-12-18 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.