NDC 68516-1001 - 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
- 68516-1001
- Package NDCs from labels
- 68516-1001-1
- 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 |
| Factor IX Complex Profilnine ® | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2026-04-01 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-1001-1 | Profilnine | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 33 |
| 68516-1001-1 | Alphanate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 26 |
| 68516-1001-1 | Alphanate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 26 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-1001 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip |
| 68516-1001 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | Hospira, Inc. | af6aebad-ef03-4d19-9a40-18e5a278b812 | 2025-11-11 | Warnings, Adverse reactions | 451W47IQ8X |
| GURUNANDA NASAL SALINE | NASAL WASH | GURUNANDA LLC | 27dbf0bf-c273-2108-e063-6394a90a0a09 | 2025-11-10 | Warnings | 451W47IQ8X |
| AZO Yeast Plus | CANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFUR | i-Health, Inc. | 22845cac-8011-4ea8-b35e-b72973eddb44 | 2025-11-07 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Henry Schein, Inc. | 2e81ffca-05c6-4fa0-8911-4b3cbfa71351 | 2025-11-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Rising Pharma Holdings, Inc. | 42870188-b1d7-4934-a6c0-310530497dac | 2025-11-07 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | d8b8d796-bfba-42af-a859-99d776871558 | 2025-11-07 | Adverse reactions | 451W47IQ8X |
| STERILE WATER | WATER | Henry Schein, Inc. | f4087143-9868-4308-b96c-43657ee8ec28 | 2025-11-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Bacteriostatic Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | 31188cdf-7bc8-4d78-bfaf-c1dc9f851fd4 | 2025-11-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | d3d29c8f-c326-4097-814a-7f4e08c67068 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X |
| Ringers | SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE | B. Braun Medical Inc. | 01721071-af03-4894-95c1-10b8bc64b888 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose in Lactated Ringers | DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | 190da07e-a616-46e6-b4e5-1c0ba39306e5 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | f6d82772-638c-4584-b9d3-8833669f5963 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X |
| Bacteriostatic Water | BACTERIOSTATIC WATER | ProPharma Distribution | 42c6938e-f747-ae13-e063-6294a90a59a3 | 2025-11-04 | Warnings, Adverse reactions | 059QF0KO0R |
| Com-Pare2 Dual Yeast Relief Plus Multi-symptom Formula | CANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHUR | TRP Company | 42b6b9b9-a673-0bba-e063-6394a90a8866 | 2025-11-03 | Warnings | 451W47IQ8X |
| 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 |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | ICU Medical Inc. | d8ee14e9-6733-4813-9f21-2b043a5f7188 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | ICU Medical Inc. | 4555b1bf-6d97-4798-a63d-6d34291c85ce | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | ICU Medical Inc. | 9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.