NDC 68516-3604-2 - 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
- Requested NDC
- 68516-3604-2
- 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 |
|---|---|---|---|---|---|---|
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE) | Energetix Corp | 9883c502-9782-451e-9eec-c54d7b054f31 | 2017-01-31 | Warnings | 451W47IQ8X |
| Tox-Chord | ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM | Energetix Corp | 6b0d1628-b20d-426e-9c84-5cceadca3f45 | 2016-11-11 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2a96096d-43cc-49b7-af53-b53c17f41001 | 2014-07-25 | Warnings, Adverse reactions | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | b3b4b176-41f0-4ca8-90d4-3fba5707564a | 2014-02-21 | 451W47IQ8X | |
| TIS-U-SOL | SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE | Baxter Healthcare Corporation | 9da4121f-d62d-4da4-8dfb-0494da16015f | 2014-02-21 | 451W47IQ8X | |
| Ringers | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, | Baxter Healthcare Corporation | e1953d54-818d-46a6-8532-518ebae6d84e | 2012-06-13 | 451W47IQ8X | |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | f09f80bf-2f8b-4420-865d-aec2d5e5cd4d | 2012-06-12 | 451W47IQ8X | |
| d1cbb346-51fa-4f78-b233-7faa958d1c6b | 3e99052d-4442-4283-8915-c9a796c77008 | 2010-08-01 | Warnings, Adverse reactions | 3e99052d-4442-4283-8915-c9a796c77008 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.