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 |
|---|---|---|---|---|---|---|
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80 | Allergan, Inc. | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 2022-09-01 | Warnings | 6OZP39ZG8H |
| 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 | OF5P57N2ZX 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 |
| REFRESH Optive Mega-3 | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | c5f2b3f2-2071-45bd-a010-67f848bc0233 | 2022-06-30 | Warnings | 6OZP39ZG8H |
| 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 | |
| ACD Blood-Pack Units (PL 146 PLASTIC) | ANTICOAGULANT CITRATE DEXTROSE (ACD) | Fenwal, Inc. | ba894daa-688e-4a9e-bd74-e71797f951bb | 2022-04-27 | B22547B95K | |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.