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 |
|---|---|---|---|---|---|---|
| Dr Talbots Infant Daily Allergy Relief | ALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6X | Talbot's Pharmaceuticals Family Products,LLC. | e8bdcc8a-c947-ff5d-e053-2a95a90a3b92 | 2022-09-12 | Warnings | 451W47IQ8X |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | 6a1322c7-7767-4569-aa22-9d2e36331283 | 2022-08-30 | Warnings | 451W47IQ8X |
| Kids Cold and Cough Nighttime Grape Flavor | ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR | Hyland's Consumer Health Inc. | e676dbb7-212f-47e3-e053-2995a90af4e1 | 2022-08-17 | Warnings | 451W47IQ8X |
| Kids Cold and Cough Daytime Grape Flavor | ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR | Hyland's Consumer Health Inc. | e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d | 2022-08-16 | Warnings | 451W47IQ8X |
| Sterile Saline Kids Mist PediaMeds | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | e5c5b580-1d9f-3081-e053-2995a90a8031 | 2022-08-08 | Warnings | 451W47IQ8X |
| Sterile Saline Kids Mist SinuCleanse Breathe | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | e5c5c313-046f-b0a7-e053-2a95a90a2a07 | 2022-08-08 | Warnings | 451W47IQ8X |
| Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Company | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 2022-08-04 | Boxed warning, Warnings, Adverse reactions | 4QD397987E |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | 123bd10a-90c7-499e-97f6-acf7e0f0fb4e | 2022-07-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | fad9615f-7004-415d-9f69-ee9ff95f0067 | 2022-07-12 | Warnings | 451W47IQ8X |
| BHI Constipation | DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED | MediNatura Inc | 0365b75b-fee4-4c1d-89ab-c692bdd73f75 | 2022-07-07 | Warnings | 451W47IQ8X |
| Natrium Muriaticum 6X | SODIUM CHLORIDE | Seroyal USA | 0ebf18de-12fe-0bc4-e054-00144ff88e88 | 2022-07-07 | Warnings | 451W47IQ8X |
| Erogetone | ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA | Energique, Inc. | 1e872ecd-e7a5-463d-9832-47b7046096db | 2022-06-28 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Cardioplegic Solution | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Fresenius Kabi, USA, LLC | eb360dc4-88d6-4b28-9b61-bc359e16bd22 | 2022-05-27 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Calcarea Muriatica | CALCAREA MURIATICA | Hahnemann Laboratories, INC. | df517477-164b-33cc-e053-2a95a90a2083 | 2022-05-18 | M4I0D6VV5M | |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 24a08a93-df23-474b-873e-c59ec8855f9f | 2022-03-14 | Warnings, Adverse reactions | 451W47IQ8X |
| Wild Horse 777 Moisturizing Nasal | SODIUM CHLORIDE | Wild Horse 777, Inc. | b0b4dadd-11fa-3dbb-e053-2995a90a2097 | 2022-03-14 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | cc14fafd-3dcd-4fc8-bdbd-6f355c375768 | 2022-02-23 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 8b44bfd3-70a4-4b47-bc7b-590f63b8cc75 | 2022-02-15 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.