NDC 76125-669 - 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
- 76125-669
- Package NDCs from labels
- 76125-669-31
- 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 |
|---|---|---|---|---|---|---|
| 76125-669-31 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 23 |
| 76125-669-31 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 23 |
| 76125-669-31 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 23 |
| 76125-669-31 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 10 |
| 76125-669-31 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 10 |
| 76125-669-31 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76125-669 | KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] | 23 | Unmatched | 20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip |
| 76125-669 | 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 |
|---|---|---|---|---|---|---|
| Hypertonic Saline | SODIUM CHLORIDE | NAVEH PHARMA (1996) LTD | 167c7a9c-1228-4fb2-a89c-d3e148386323 | 2026-07-30 | Warnings | 451W47IQ8X |
| Hypertonic Saline Solution Sodium Chloride | SODIUM CHLORIDE | NAVEH PHARMA (1996) LTD | 750ea4b1-de2b-4299-aaa2-331daf383d0d | 2026-07-30 | Warnings | 451W47IQ8X |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | bbc5b820-4973-11e2-a192-0002a5d5c51b | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | c29bdfa0-4976-11e2-939b-0002a5d5c51b | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Delflex | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | a98facd6-9daa-4d37-8209-63a0599dbfaa | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | 515dcee0-3e34-11e2-a25f-0800200c9a66 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | 9a1220fb-6853-45ae-838c-10d8596e1af7 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | af5cdf1a-19f4-11e2-892e-0800200c9a66 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| PEG 3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | A-S Medication Solutions | 19daf830-7270-4661-81b1-ded38f867f28 | 2026-07-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Cardinal Health 107, LLC | 9655cd02-82b5-4a75-813b-854b19551481 | 2026-07-21 | Warnings, Adverse reactions | 059QF0KO0R |
| Whisidom Saline Solution | SODIUM CHLORIDE 0.9% SALINE SOLUTION | Jiangxi Yudexi Pharmaceutical Co., LTD | 4e4e4169-2a14-3466-e063-6394a90a081b | 2026-07-20 | Warnings | 451W47IQ8X |
| Saline | NASAL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 71485e82-bf54-4b8b-8dd2-2a0761534520 | 2026-07-17 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | LABORATORIOS GRIFOLS SA | eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf | 2026-07-15 | Warnings, Adverse reactions | 451W47IQ8X |
| WHWSWB 0.9% SALINE | SODIUM CHLORIDE | Yiwu Huanshu E-commerce Co., Ltd | 5082b773-79b2-2501-e063-6394a90a170f | 2026-07-11 | Warnings | 451W47IQ8X |
| SALINE NASAL | SODIUM CHLORIDE | ALAINA HEALTHCARE PRIVATE LIMITED | ed30a7f9-7132-42da-9bed-63a9b1c80ab2 | 2026-07-07 | Warnings | 451W47IQ8X |
| Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g) | NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE) | Reedfresh Co., LTD | 55d703ca-ff9d-0dbc-e063-6294a90ab6b1 | 2026-07-05 | Warnings | 059QF0KO0R |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Protective Industrial Products, Inc. | 558e5926-9027-d3f6-e063-6294a90ab121 | 2026-07-02 | Warnings | 059QF0KO0R |
| Fendall 2000 Pure Flow | PURIFIED WATER | Protective Industrial Products, Inc. | 55a1d07e-0006-0c75-e063-6394a90a7acc | 2026-07-02 | Warnings | 059QF0KO0R |
| Fendall 1000 Pure Flow | PURIFIED WATER | Protective Industrial Products, Inc. | 55a2f4da-bb1e-8ead-e063-6394a90af72e | 2026-07-02 | Warnings | 059QF0KO0R |