NDC 13533-200 - FESILTY
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
- 13533-200
- Package NDCs from labels
- 13533-200-50, 13533-200-10, 13533-200-05, 13533-200-20
- Manufacturer
- Grifols USA LLC | Biotest AG | Grifols Therapeutics LLC | Laboratorios Grifols, S.A. | Instituto Grifols, S.A. | Prothya Biosolutions Belgium | TechPharm GmbH | GBA Pharma GmbH
- Effective date
- 2026-08-20
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| FESILTY | Grifols USA LLC | Biotest AG | Grifols Therapeutics LLC | Laboratorios Grifols, S.A. | Instituto Grifols, S.A. | Prothya Biosolutions Belgium | TechPharm GmbH | GBA Pharma GmbH | 2026-08-20 | PLASMA DERIVATIVE |
| Alanine - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | 2025-08-21 | PLASMA DERIVATIVE |
| 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 |
| PROLASTIN-C - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | 2022-02-25 | PLASMA DERIVATIVE |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13533-200 | THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip |
| 13533-200 | PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20220308_91edab72-c889-470e-8315-1798b5548dca.zip |
| 13533-200 | KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] | 23 | Unmatched | 20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip |
| 13533-200 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 0e089a44-0cee-4804-8f6f-8508508ddb5c | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 189b8ac6-e346-454f-b501-7645590ca4f8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Cold and Cough 4 Kids | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Hyland's Inc. | e06599ca-fc94-4b2c-829e-f3d4ec866ed6 | 2025-10-29 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 97007188-43fe-416c-a87b-6ccc4d9ae2ec | 2025-10-29 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | 05f326e6-10e4-4ceb-8a23-f53c592f00b8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Corporation | 6acc9f96-7088-45a7-b48f-1a861e3467ab | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Lactated Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE | Baxter Healthcare Company | dad7735c-709b-40ea-ab7a-15577e24a966 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| WALMART SALINE | SALINE NASAL (SODIUM CHLORIDE) | WALMART STORES INC | 06906744-49a5-4bab-8539-af2d235df9e8 | 2025-10-28 | Warnings | 451W47IQ8X |
| Saline | NASAL | PUBLIX SUPER MARKETS, INC | 19841567-9511-43d6-ba4e-d1e1bd3481a4 | 2025-10-28 | Warnings | 451W47IQ8X |
| Bacteriostatic Water | WATER | Henry Schein, Inc. | a833502e-a622-4e81-8c58-cef6ccb6c4c9 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.