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 table
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 table
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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Alpha-1-proteinase Inhibitor Human	ACTIVE INGREDIENT	F43I396OIS	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Alpha-1-proteinase Inhibitor Human	ACTIVE MOIETY	F43I396OIS	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Sodium Phosphate	INACTIVE INGREDIENT	SE337SVY37	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Antihemophilic Factor Human	ACTIVE INGREDIENT	839MOZ74GK	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Antithrombin Iii Human	ACTIVE INGREDIENT	T0LTO7L82X	THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]	11
Antihemophilic Factor Human	ACTIVE MOIETY	839MOZ74GK	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Antithrombin Iii Human	ACTIVE MOIETY	T0LTO7L82X	THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]	11
Albumin (human)	INACTIVE INGREDIENT	ZIF514RVZR	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Aluminum	INACTIVE INGREDIENT	CPD4NFA903	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Calcium Chloride	INACTIVE INGREDIENT	M4I0D6VV5M	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Glycine	INACTIVE INGREDIENT	TE7660XO1C	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Histidine	INACTIVE INGREDIENT	4QD397987E	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Tri-n-butyl Phosphate	INACTIVE INGREDIENT	95UAS8YAF5	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11

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.

Matched openFDA labels page 29 of 56 · 1,113 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bestmade Natural Products BM68	PHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARB	Bestmade Natural Products	2cec9c90-2e61-f005-e063-6294a90a8753	2025-01-30	Warnings	Exact identifier unii: 451W47IQ8X
Recovatone	GLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,	Energique, Inc.	8ca76872-a187-4fd8-8daf-9ee351bdf346	2025-01-28	Warnings	Exact identifier unii: 451W47IQ8X
WHP Headache	ATROPA BELLADONNA - BRYONIA ALBA ROOT - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEED	Washington Homeopathic Products	06d25564-4c7e-0b3a-e063-6294a90a38bf	2025-01-28	Warnings	Exact identifier unii: 451W47IQ8X
Fever-Infection	CHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUM	Newton Laboratories, Inc.	9d762268-8c30-8a86-e053-2a95a90a419c	2025-01-27	Warnings	Exact identifier unii: 451W47IQ8X
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.	5a94659f-b62a-41d8-81c0-87a68c02606d	2025-01-27	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products BM59	CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCC	Bestmade Natural Products	2c763956-a1de-c8df-e063-6294a90a5c81	2025-01-24	Warnings	Exact identifier unii: 451W47IQ8X
Equate Sterile Saline Mist	SODIUM CHLORIDE	WALMART INC.	275ada29-8904-fe1e-e063-6394a90abe59	2025-01-24	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Citrate w/v Anticoagulant	TRISODIUM CITRATE DIHYDRATE	Terumo BCT, Ltd	c9d0e9c8-379f-4895-b272-329efab575c4	2025-01-24	Warnings, Adverse reactions	Exact identifier unii: B22547B95K
Glucose and Sodium Chloride	DEXTROSE ANHYDROUS AND SODIUM CHLORIDE	Baxter Healthcare Corporation	1ba918d0-13d0-48bc-8742-658fc0eb47b6	2025-01-24		Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	93aeac13-41de-4452-9f38-d6b4f38ada30	2025-01-24		Exact identifier unii: 451W47IQ8X
Bestmade Natural Products BM33	ACID FOLICD10, ACID PHOSD4, ARSENIC ALBD4, AVENA SATD3, BETA VULGD5, CHINA OFFD12, FERR METD5, NATRUM MURD5	Bestmade Natural Products	ef2beaff-5c94-de60-e053-2995a90ad796	2025-01-23	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Citrate 4% w/v Anticoagulant	TRISODIUM CITRATE DIHYDRATE	Terumo BCT, Ltd	0775912f-f14a-4967-ac00-c8c1b36040bf	2025-01-23	Warnings, Adverse reactions	Exact identifier unii: B22547B95K
Bestmade Natural Products Nat Mur (Lactose-Free)	NATRUM MURIATICUM	Bestmade Natural Products	2c4b8827-e724-858a-e063-6394a90a3b4e	2025-01-22	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Bio1	CALC PHOS, FERR PHOS, KALI PHOS, NAT MUR	Bestmade Natural Products	e9fb280b-2f79-f268-e053-2995a90a732c	2025-01-22	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Bio2	KALI PHOS, MAG PHOS, NAT MUR, NAT SULF	Bestmade Natural Products	e9fc4f2f-a699-163f-e053-2995a90ab1fe	2025-01-22	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Bio4	CALC FLUOR, KALI MUR, NAT MUR, SILICEA	Bestmade Natural Products	ea224687-106e-3821-e053-2995a90aa69c	2025-01-22	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Bio5	FERR PHOS, KALI MUR, NAT MUR, KALI SULPH	Bestmade Natural Products	ea22e5e7-491a-91ac-e053-2a95a90a4414	2025-01-22	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Bio6	FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPH	Bestmade Natural Products	ea233792-038f-39e7-e053-2995a90a20ad	2025-01-22	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Bio11	FERR PHOS, KALI MUR, KALI SULF, NAT MUR, NAT SULF	Bestmade Natural Products	eaa202d7-4297-57ba-e053-2995a90a0295	2025-01-22	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Bio12	FERR PHOS, NAT MUR, KALI PHOS, MAG PHOS	Bestmade Natural Products	eab251db-c69a-572d-e053-2a95a90ab3a0	2025-01-22	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.