NDC 68516-3604 - AlphaNine SD
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
- 68516-3604
- Package NDCs from labels
- 68516-3604-2
- Manufacturer
- GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA
- Effective date
- 2025-05-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 68516-3604-2 | AlphaNine SD | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 500 [iU] in 10mL | 25 |
| 68516-3604-2 | AlphaNine SD | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 500 [iU] in 10mL | 25 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-3604 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 24 | Unmatched | 20240123_3e99052d-4442-4283-8915-c9a796c77008.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| COAGULATION FACTOR IX HUMAN | ACTIVE INGREDIENT | 6U90Y1795T | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| Coagulation Factor IX Human | ACTIVE MOIETY | 6U90Y1795T | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| dextrose | INACTIVE INGREDIENT | IY9XDZ35W2 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| heparin | INACTIVE INGREDIENT | T2410KM04A | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 |
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 |
|---|---|---|---|---|---|---|
| Elliotts B | SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE | Lukare Medical, LLC | 08036dbd-55b3-47b9-9890-000f253544f3 | 2024-10-16 | Warnings, Adverse reactions | 451W47IQ8X |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Fresenius Kabi USA, LLC | 8fce1477-991f-4b43-bf05-a80bad897262 | 2024-10-16 | Warnings, Adverse reactions | 451W47IQ8X |
| EyS Eye Wash | WATER | Eyes-Plus LLC | 1443f6bf-3a77-4a19-8585-0ec58efe042f | 2024-10-15 | Warnings | 059QF0KO0R |
| Eye Wash | WATER SOLUTION | Kroger Company | 354402ad-581d-47e7-9fd3-933bef281ff4 | 2024-10-11 | Warnings | 059QF0KO0R |
| Eye Wash | WATER | Hubei Changjian Medical Products Co., Ltd. | d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea | 2024-10-11 | Warnings | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | c44b0fdb-33df-4747-b443-5fb4deb456cb | 2024-10-11 | Warnings, Adverse reactions | 451W47IQ8X |
| Bacteriostatic Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | e5e325d1-0d58-40c9-9645-3ae402ff9d92 | 2024-10-11 | Warnings, Adverse reactions | 451W47IQ8X |
| Vamousse Lice Defense | EUCALYPTUS GLOBULUS, NATRUM MURIATICUM | Alliance Pharma Inc. | c87ce5d3-c200-421e-88be-bc8060a5993a | 2024-10-08 | Warnings | 451W47IQ8X |
| Energy Catalyst | VISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS, POTASSIUM ASPARTATE, SODIUM MOLYBDATE, ADENOSINUM, CYCLOPHOSPHORICUM, CERIUM OXALICUM, NICKEL ACETATE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, ALUMINA, | Deseret Biologicals, Inc. | 99529dd4-f8ab-4348-8b65-dc8c89e1ad54 | 2024-10-04 | Warnings | 451W47IQ8X |
| Thyroid HP | BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, LAPIS ALBUS, LEVOTHYROXINUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SELENIUM METALLICUM, SPONGIA TOSTA, THYROIDINUM (SUIS) | Energique, Inc. | 2f04e425-7160-41a7-aa1e-934db54f1751 | 2024-09-30 | Warnings | 451W47IQ8X |
| 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, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM | Energique, Inc. | cb1566a4-92d4-4f1a-9211-f0c538a83c27 | 2024-09-27 | Warnings | 451W47IQ8X |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | cc3d5bc8-9d3c-4c65-9e43-707a2db4081a | 2024-09-25 | Warnings | 451W47IQ8X |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 93fafa27-5031-4d95-b4b8-5574b7204ae2 | 2024-09-25 | Warnings | 451W47IQ8X |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 454f337e-d897-46de-ab05-1c543a33061c | 2024-09-25 | Warnings | 451W47IQ8X |
| Defense | PETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR (BOVINE), MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (OVINE), SACCHARINUM | Nutritional Specialties, Inc. | ddd879cf-1a85-4b8d-bdb0-5cf495fea4e6 | 2024-09-24 | Warnings | 451W47IQ8X |
| HP Axis | ARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONE | Deseret Biologicals, Inc. | 402f5b05-c71e-4dba-bc2b-049aee42952a | 2024-09-23 | Warnings | 451W47IQ8X |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 3c5f0f65-8a54-4a55-ad4e-0f0be97631d7 | 2024-09-15 | Warnings, Adverse reactions | 451W47IQ8X |
| Thyroid HP | BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SPONGIA TOSTA, THYROIDINUM (SUIS) | Energique, Inc. | 3a4f9647-a4d9-4bca-96d1-ec717f938d4a | 2024-09-11 | Warnings | 451W47IQ8X |
| Defense | PETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR SUIS, MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (BOVINE) SACCHARINUM | Nutritional Specialties, Inc. | b5516749-54dd-4287-b2db-78164810de7a | 2024-09-11 | Warnings | 451W47IQ8X |
| Itch Formula | CALENDULA OFFICINALIS, APIS MELLIFICA, NATRUM MURIATICUM, URTICA URENS, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, SULPHUR, COPAIVA OFFICINALIS, CANTHARIS, CROTON TIGLIUM, GRAPHITES, MEZEREUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, ANTIPYRINUM | Deseret Biologicals, Inc. | 79c21a7b-ffb7-4b0d-a702-8aec0463be81 | 2024-09-11 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.