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 |
|---|---|---|---|---|---|---|
| Weed Grass Antigens | ALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS, | Energique, Inc. | 8a28f56a-6010-42e3-b360-e6e22b86222a | 2024-05-02 | Warnings | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | c2467d57-cd2d-4409-bcc0-50128bd01bba | 2024-04-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Mineffect eye drops | ALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM | Kadesh Incoporation Co,Ltd | e2259f58-3043-4af3-918d-d4403757aa1f | 2024-04-26 | Warnings | 451W47IQ8X |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Fresenius Kabi USA, LLC | 7a723a23-3bc1-4f69-b82f-d06a35dc68d6 | 2024-04-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | c1e52670-c85e-4f19-a2e9-bf9abd7c3727 | 2024-04-23 | Warnings, Adverse reactions | 451W47IQ8X |
| PEMF Optimizer | AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 97d57469-4c5b-4d3f-9398-3a1a6617a649 | 2024-04-23 | Warnings | 059QF0KO0R |
| Dermapar | EPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUM | Energique, Inc. | f79fe29b-341e-4bee-9665-1805a7157d1a | 2024-04-22 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Hikma Pharmaceuticals USA Inc. | e5ee8caa-b6ca-45ba-98fb-8305e6282141 | 2024-04-10 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Hers Plus | CALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALIS | Deseret Biologicals,Inc. | e4636b80-f6c8-459c-8d0e-ff7801358b10 | 2024-04-09 | Warnings | 451W47IQ8X |
| Dextrose And Sodium Chloride | DEXTROSE AND SODIUM CHLORIDE | B. Braun Medical Inc. | 8e6569ce-9714-497f-a94b-c6975c1d76f6 | 2024-04-02 | Warnings, Adverse reactions | 451W47IQ8X IY9XDZ35W2 |
| Vascuflow | MELATONIN, L-ARGININE, L-CITRULLINE, UBIDECARENONUM, SQUALENE, CALCAREA CARBONICA, CHOLESTERINUM, COUMARINUM, FORMALINUM, GELSEMIUM SEMPERVIRENS, ALPHA-LIPOICUM ACIDUM, MERCURIUS CORROSIVUS, PLUMBUM METALLICUM, PANTOTHENIC ACID, GLONOINUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, BERBERIS VULGARIS, RED YEAST RICE, NITRIC OXIDE, PROTEUS (MORGANI), RHUS TOX | Deseret Biologicals, Inc. | 1ca5d57d-7cf0-4b9a-afa0-767dca99864d | 2024-04-02 | Warnings | 94ZLA3W45F |
| SINU HC | PLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUM | Deseret Biologicals, Inc. | 8b63e066-dd1b-4aee-a17b-4edc6b71a1cc | 2024-04-02 | Warnings | 451W47IQ8X |
| Eye Wash | WATER | M-star (Hubei) Health&Care Products Co., Ltd. | 71706039-e250-4f08-9687-71b2928c4e46 | 2024-04-01 | Warnings | 059QF0KO0R |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 14931004-1efb-e331-e063-6294a90ad66e | 2024-03-26 | Warnings | 451W47IQ8X |
| Aqua marina | SODIUM CHLORIDE | Boiron | 14945760-30b5-27d3-e063-6394a90a8a32 | 2024-03-26 | 451W47IQ8X | |
| Headache HP | BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM | Energique, Inc. | 5dca8670-c931-47e3-af89-b5f09f5f4e02 | 2024-03-26 | Warnings | 451W47IQ8X |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | B. Braun Medical Inc. | 59ccc717-c374-41c0-be58-9647df881160 | 2024-03-26 | Warnings, Adverse reactions | 451W47IQ8X IY9XDZ35W2 |
| V-Fem Care | AGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELIS | Newton Laboratories, Inc. | 14800c19-e5c6-924b-e063-6394a90a15e5 | 2024-03-25 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.