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 |
|---|---|---|---|---|---|---|
| SinuCleanse | SODIUM BICARBONATE, SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | c33bf872-54aa-45e0-9e40-a6565a13f198 | 2025-01-31 | Warnings | 451W47IQ8X |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Citragen Pharmaceuticals Inc | aae783b2-18fe-69ca-e053-2a95a90a0800 | 2025-01-30 | Warnings | 451W47IQ8X |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Citragen Pharmaceuticals Inc | 82c29f1d-a018-7483-e053-2a91aa0a8f7e | 2025-01-30 | Warnings | 451W47IQ8X |
| Bestmade Natural Products BM63 | CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADEN | Bestmade Natural Products | 2cea4552-3700-3da3-e063-6294a90a14b5 | 2025-01-30 | Warnings | 059QF0KO0R |
| Bestmade Natural Products BM68 | PHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARB | Bestmade Natural Products | 2cec9c90-2e61-f005-e063-6294a90a8753 | 2025-01-30 | Warnings | 451W47IQ8X |
| Recovatone | GLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, | Energique, Inc. | 8ca76872-a187-4fd8-8daf-9ee351bdf346 | 2025-01-28 | Warnings | 451W47IQ8X 94ZLA3W45F |
| WHP Headache | ATROPA BELLADONNA - BRYONIA ALBA ROOT - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEED | Washington Homeopathic Products | 06d25564-4c7e-0b3a-e063-6294a90a38bf | 2025-01-28 | Warnings | 451W47IQ8X |
| Fever-Infection | CHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUM | Newton Laboratories, Inc. | 9d762268-8c30-8a86-e053-2a95a90a419c | 2025-01-27 | Warnings | 451W47IQ8X |
| Histastat Pollen | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDES | Energique, Inc. | 5a94659f-b62a-41d8-81c0-87a68c02606d | 2025-01-27 | Warnings | 451W47IQ8X |
| Bestmade Natural Products BM59 | CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCC | Bestmade Natural Products | 2c763956-a1de-c8df-e063-6294a90a5c81 | 2025-01-24 | Warnings | 451W47IQ8X |
| Equate Sterile Saline Mist | SODIUM CHLORIDE | WALMART INC. | 275ada29-8904-fe1e-e063-6394a90abe59 | 2025-01-24 | Warnings | 451W47IQ8X |
| Glucose and Sodium Chloride | DEXTROSE ANHYDROUS AND SODIUM CHLORIDE | Baxter Healthcare Corporation | 1ba918d0-13d0-48bc-8742-658fc0eb47b6 | 2025-01-24 | 451W47IQ8X | |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 93aeac13-41de-4452-9f38-d6b4f38ada30 | 2025-01-24 | 451W47IQ8X | |
| Bestmade Natural Products BM33 | ACID FOLICD10, ACID PHOSD4, ARSENIC ALBD4, AVENA SATD3, BETA VULGD5, CHINA OFFD12, FERR METD5, NATRUM MURD5 | Bestmade Natural Products | ef2beaff-5c94-de60-e053-2995a90ad796 | 2025-01-23 | Warnings | 451W47IQ8X |
| Anticoagulant Citrate Dextrose A ACD-A | ANTICOAGULANT CITRATE DEXTROSE A ACD-A | Arteriocyte Medical Systems, Inc. | b850deac-161f-4bb0-ac7f-bceac2a230c0 | 2025-01-23 | 1Q73Q2JULR | |
| Bestmade Natural Products Nat Mur (Lactose-Free) | NATRUM MURIATICUM | Bestmade Natural Products | 2c4b8827-e724-858a-e063-6394a90a3b4e | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio1 | CALC PHOS, FERR PHOS, KALI PHOS, NAT MUR | Bestmade Natural Products | e9fb280b-2f79-f268-e053-2995a90a732c | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio2 | KALI PHOS, MAG PHOS, NAT MUR, NAT SULF | Bestmade Natural Products | e9fc4f2f-a699-163f-e053-2995a90ab1fe | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio4 | CALC FLUOR, KALI MUR, NAT MUR, SILICEA | Bestmade Natural Products | ea224687-106e-3821-e053-2995a90aa69c | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio5 | FERR PHOS, KALI MUR, NAT MUR, KALI SULPH | Bestmade Natural Products | ea22e5e7-491a-91ac-e053-2a95a90a4414 | 2025-01-22 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.