NDC 76125-252 - Koate
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
- 76125-252
- Package NDCs from labels
- 76125-252-21
- Manufacturer
- KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA
- Effective date
- 2023-12-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | 2023-12-13 | PLASMA DERIVATIVE |
| Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | 2023-12-12 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76125-252-21 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 250 [iU] in 5mL | 23 |
| 76125-252-21 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 250 [iU] in 5mL | 23 |
| 76125-252-21 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 250 [iU] in 5mL | 23 |
| 76125-252-21 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 250 [iU] in 5mL | 10 |
| 76125-252-21 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 250 [iU] in 5mL | 10 |
| 76125-252-21 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 250 [iU] in 5mL | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76125-252 | KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] | 23 | Unmatched | 20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip |
| 76125-252 | KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] | 10 | Unmatched | 20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.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 |
|---|---|---|---|---|---|---|
| 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 M4I0D6VV5M |
| Ringers | SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE | B. Braun Medical Inc. | 01721071-af03-4894-95c1-10b8bc64b888 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| 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 M4I0D6VV5M |
| 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 M4I0D6VV5M |
| 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 |
| 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 |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 3cfdeee0-ff14-4341-8396-b11c2a037c60 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 5f372b75-d7a4-471e-8ac6-290040fc84b0 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | ICU Medical Inc. | 243fe8fc-996a-4855-8daf-069628e547c4 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | d310d170-5eeb-471b-af1a-0e845001d21d | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 009bef3c-e8ac-46be-b564-a2556adf0081 | 2025-10-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Lactated Ringers and Dextrose | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | 237b39fa-916e-4a54-99c8-4ae9ad54f056 | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Normosol-R and Dextrose | DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | ead1fca3-eff4-478f-8a8f-67510f80151a | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.