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 |
|---|---|---|---|---|---|---|
| BM BIO28 ICING SUGAR | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 3e855f3b-c73d-a153-e063-6394a90ad63a | 2025-12-02 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio28 | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 3e85a931-57f6-2a55-e063-6294a90ac180 | 2025-12-02 | Warnings | 451W47IQ8X |
| Bestmade Natural Products BIO28 | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA: Bestmade Natural Products Micro | 3e46ee90-2c2c-0a70-e063-6294a90a576a | 2025-12-02 | Warnings | 451W47IQ8X |
| BM Nat Mur | NATRIUM MURIATICUM | BM Private Limited | 37b12318-dff9-e32a-e063-6394a90a18e8 | 2025-12-02 | Warnings | 451W47IQ8X |
| BM Nat Mur Icing Sugar | NATRUM MURIATICUM ICING SUGAR | BM Private Limited | 37c27f80-7689-c5a1-e063-6294a90a619b | 2025-12-02 | Warnings | 451W47IQ8X |
| Walgreens Saline | NASAL | WALGREEN COMPANY | 147e45c8-1e71-4c06-89f1-42e9f9683366 | 2025-12-01 | Warnings | 451W47IQ8X |
| Walgreen Anti Nausea Cherry Flavor | PHOSPHORATED CARBOHYDRATE | WALGREENS CO. | 69e72d30-feca-454d-addc-8ed7325568d3 | 2025-12-01 | Warnings | IY9XDZ35W2 |
| Sterile Saline Mist Meijer | SODIUM CHLORIDE | Meijer, Inc. | 445c8f4f-0519-0764-e063-6294a90a8b39 | 2025-12-01 | Warnings | 451W47IQ8X |
| Walgreen Saline | NASAL | WALGREENS CO. | ee264d8b-0bb2-472a-907c-6a6291f154cd | 2025-11-26 | Warnings | 451W47IQ8X |
| ACD-A | ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A | Fenwal, Inc. | ab19b011-0a51-4f04-9881-d9fc7cae95ae | 2025-11-25 | 1Q73Q2JULR | |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | beda35c3-9a8b-47ad-e053-2995a90a7b1b | 2025-11-24 | Warnings | 059QF0KO0R |
| Easy Care First Aid Eyewash | WATER | Tender Corporation | a070aac8-e6d2-ef10-e053-2a95a90aa5b1 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | e07a064b-f680-405c-bbcd-24fac430951e | 2025-11-24 | Warnings | 059QF0KO0R |
| ULINE Eyewash | EYEWASH | Niagara Pharmaceuticals Inc. | 2d7f22d2-320b-6af1-e063-6294a90addc6 | 2025-11-24 | Warnings | 059QF0KO0R |
| Pur-Wash | EYEWASH | Niagara Pharmaceuticals, Inc. | 0d43b1c1-2699-37f1-e054-00144ff88e88 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 777e1559-786f-8d54-e053-2991aa0aa98d | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 7289103a-5cbf-42f4-8848-e827149a43ca | 2025-11-24 | Warnings | 059QF0KO0R |
| Natural Eyes Floaters Relief | CHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEA | TRP Company | 445dc831-195e-4b25-e063-6294a90a6efd | 2025-11-24 | Warnings | 451W47IQ8X |
| Eyewash Additive Concentrate | WATER AND PROPYLENE GLYCOL | Haws Corporation | dd168403-398c-41ff-b1df-d93e4ff39de3 | 2025-11-20 | Warnings | 059QF0KO0R |
| Vital Female Sexual Energy | AGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS | Liddell Laboratories, Inc. | 1ca43c82-62b0-4191-81a4-27f7f94109dd | 2025-11-20 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.