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 |
|---|---|---|---|---|---|---|
| Cyclease PMS | ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE | Laboratoires Boiron | 09ff0633-2992-4aba-96ed-45a69f3ee589 | 2023-05-30 | Warnings | 451W47IQ8X |
| Calcium Chloride | CALCIUM CHLORIDE | Medical Purchasing Solutions, LLC | 6685165a-0df7-0ae0-e053-2a91aa0a3f22 | 2023-05-30 | Warnings, Adverse reactions | M4I0D6VV5M |
| Calcium Chloride | CALCIUM CHLORIDE | Medical Purchasing Solutions, LLC | 6b15706b-199c-beba-e053-2991aa0a1734 | 2023-05-30 | Warnings, Adverse reactions | M4I0D6VV5M |
| BACTERIOSTATIC SODIUM CHLORIDE | SODIUM CHLORIDE | Medical Purchasing Solutions, LLC | 8a0d24a9-d02a-0379-e053-2a95a90af712 | 2023-05-23 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| Bacteriostatic Water | WATER | Medical Purchasing Solutions, LLC | 69485218-9343-952d-e053-2a91aa0ad4e8 | 2023-05-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Histastat Pollen | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDES | Energique, Inc. | 00478787-ccec-4101-a0da-fd337037c3ee | 2023-05-12 | Warnings | 451W47IQ8X |
| Calcium Chloride | CALCIUM CHLORIDE INJECTION | Medical Purchasing Solutions, LLC | 9e502cf2-3f4d-13ec-e053-2a95a90a970e | 2023-05-10 | Warnings, Adverse reactions | M4I0D6VV5M |
| Sterile Water | STERILE WATER | Hikma Pharmaceuticals USA Inc. | b20a28b0-7dfa-42eb-9177-ec256d5a5ef7 | 2023-05-08 | Warnings, Adverse reactions | 059QF0KO0R |
| Natrum Muriaticum | NATRIUM MURIATICUM | True Botanica, LLC | 7d2d9129-8683-484d-e053-2a91aa0a6f8f | 2023-05-01 | Warnings | 451W47IQ8X |
| Cosmestat | ALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUM | Energique, Inc. | edc8eb65-84b3-433f-8aad-7a741f563718 | 2023-04-17 | Warnings | 451W47IQ8X |
| Baby Nighttime Mucus Plus Cold Relief | CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA | Hyland's Inc. | 736b2487-e81d-d172-e053-2a91aa0ab0cf | 2023-04-17 | Warnings | 451W47IQ8X |
| Radialgin | CITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAY | Nutritional Specialties, Inc. | f1414ae2-4068-4076-bf11-b57a34ba5df2 | 2023-04-12 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Civica, Inc. | 3f49eedf-5bf5-4a95-b704-c956d860ca04 | 2023-04-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Treprostinil | TREPROSTINIL | Sandoz Inc | 473297ca-a872-4052-a053-87dc8f0d3c13 | 2023-04-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Glutenstat | ALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTEN | Energique, Inc. | c6b867b6-74d9-4725-90d7-7d5d1fe61121 | 2023-04-05 | Warnings | 451W47IQ8X |
| Anxiety | BORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTII | Nutritional Specialties, Inc. | 657ed32f-3ac7-4806-96b4-4c7aa0f65e7f | 2023-04-03 | Warnings | 451W47IQ8X |
| Virility Liquescence | AVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIA | Nutritional Specialties, Inc. | 81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f | 2023-03-29 | Warnings | 451W47IQ8X |
| Spleen Thymus Liquescence | CINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUS | Nutritional Specialties, Inc. | bc1cc31e-0e8a-49a2-9654-f00eaa72fc04 | 2023-03-24 | Warnings | 451W47IQ8X |
| NOVOLOG | INSULIN ASPART | Novo Nordisk | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 2023-02-28 | Warnings, Adverse reactions | 059QF0KO0R |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 1ef4a040-7bee-11e6-8371-424c58303031 | 2023-02-20 | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.