NDC 68516-4606 - 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
- 68516-4606
- Package NDCs from labels
- 68516-4606-1
- 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-4606-1 | Alphanate | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 26 |
| 68516-4606-1 | Alphanate | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 26 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-4606 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX | ACTIVE INGREDIENT | 5T6B772R4Q | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 12 | |
| HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX | ACTIVE MOIETY | 5T6B772R4Q | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 12 | |
| albumin (human) | INACTIVE INGREDIENT | ZIF514RVZR | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 12 | |
| arginine | INACTIVE INGREDIENT | 94ZLA3W45F | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 12 | |
| histidine | INACTIVE INGREDIENT | 4QD397987E | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 12 |
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 |
|---|---|---|---|---|---|---|
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 7289103a-5cbf-42f4-8848-e827149a43ca | 2025-11-24 | Warnings | 059QF0KO0R |
| 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 | 94ZLA3W45F |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | fd823bef-c14c-4708-a18a-8aaa8470412f | 2025-11-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 3765c251-eb14-d60f-e063-6294a90a6a4d | 2025-11-12 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37f244fd-c02f-e66a-e063-6394a90aed81 | 2025-11-12 | Warnings | 059QF0KO0R |
| STERILE WATER | WATER | Henry Schein, Inc. | f4087143-9868-4308-b96c-43657ee8ec28 | 2025-11-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Bacteriostatic Water | BACTERIOSTATIC WATER | ProPharma Distribution | 42c6938e-f747-ae13-e063-6294a90a59a3 | 2025-11-04 | Warnings, Adverse reactions | 059QF0KO0R |
| Aminosyn II | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE | ICU Medical Inc. | 5b426208-f090-4650-86c3-89040ba45c2d | 2025-11-02 | Boxed warning, Warnings, Adverse reactions | 4QD397987E 94ZLA3W45F |
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Bacteriostatic Water | WATER | Henry Schein, Inc. | a833502e-a622-4e81-8c58-cef6ccb6c4c9 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Becton Dickinson and Company | cab03cda-4660-4020-a3be-bf86242ff664 | 2025-10-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Aminosyn-PF | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE | ICU Medical Inc. | 2d212e10-7e08-4aeb-b63f-dcc927897769 | 2025-10-17 | Warnings, Adverse reactions | 4QD397987E 94ZLA3W45F |
| Aminosyn-PF | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE | ICU Medical Inc. | 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 4QD397987E 94ZLA3W45F |
| Xpect Eyewash | EYEWASH | Cintas Corporation | 1d69365d-662b-4248-8fa9-1629451b549a | 2025-09-30 | Warnings | 059QF0KO0R |
| CheBoho TEA TREE ACNE | CHEBOHO TEA TREE ACNE | Opalshi(Guangzhou)E-commerce Co. Ltd. | 3fc4cf84-b2da-c593-e063-6394a90abc5c | 2025-09-27 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | ProPharma Distribution | 3f2ae880-852f-b45d-e063-6394a90aa1cc | 2025-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Perikabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | c2eb5522-8572-45f4-869d-42f9fd251bb6 | 2025-09-15 | Warnings, Adverse reactions | 4QD397987E 94ZLA3W45F |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.