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
LabelManufacturerEffective dateType
FESILTYGrifols USA LLC | Biotest AG | Grifols Therapeutics LLC | Laboratorios Grifols, S.A. | Instituto Grifols, S.A. | Prothya Biosolutions Belgium | TechPharm GmbH | GBA Pharma GmbH2026-08-20PLASMA DERIVATIVE
Alanine - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2025-08-21PLASMA DERIVATIVE
Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAKEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2023-12-13PLASMA DERIVATIVE
Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAKEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2023-12-12PLASMA DERIVATIVE
PROLASTIN-C - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2022-02-25PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-200THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC]29Unmatched20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip
13533-200PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC]25Unmatched20220308_91edab72-c889-470e-8315-1798b5548dca.zip
13533-200KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]23Unmatched20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip
13533-200KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]10Unmatched20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Alpha-1-proteinase Inhibitor HumanACTIVE INGREDIENTF43I396OISPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Alpha-1-proteinase Inhibitor HumanACTIVE MOIETYF43I396OISPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Sodium PhosphateINACTIVE INGREDIENTSE337SVY37PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Antihemophilic Factor HumanACTIVE INGREDIENT839MOZ74GKKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Antithrombin Iii HumanACTIVE INGREDIENTT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Antihemophilic Factor HumanACTIVE MOIETY839MOZ74GKKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Antithrombin Iii HumanACTIVE MOIETYT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Albumin (human)INACTIVE INGREDIENTZIF514RVZRKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
AluminumINACTIVE INGREDIENTCPD4NFA903KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
GlycineINACTIVE INGREDIENTTE7660XO1CKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
HistidineINACTIVE INGREDIENT4QD397987EKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Tri-n-butyl PhosphateINACTIVE INGREDIENT95UAS8YAF5KOATE -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 23 of 56 · 1,113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDENextgen Pharmaceuticals LLC28f79c75-82d2-4912-81fc-a723b5ccf4c12025-07-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEProPharma Distribution3868864f-4f46-d2a1-e063-6394a90a65d52025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HerpaOneGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions6b196d97-6446-4651-97ef-6615cf3e31732025-07-11WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE AND POTASSIUM CHLORIDEB. Braun Medical Inc.ecc38772-246a-46c4-b42a-b9b81124f27f2025-07-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Leader Sinus Wash Saline Refill PacketsSODIUM BICARBONATE, SODIUM CHLORIDECardinal Health, 110 dba LEADERfb192a6d-318e-4d2b-89b6-42ac023e4fbd2025-07-09WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.0d59a04a-32e6-485b-b638-a1e6c09e96422025-07-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Nat Mur Fluid Balance 9NATRUM MURIATICUMMartin & Pleasance Pty Ltd0b21c366-fff6-4754-a671-35481ec2c4bd2025-07-07WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDEAdvanced Rx LLC40f471b7-27cf-4ad4-aef6-cc9d0623ddd92025-07-02WarningsExact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
ParasodeARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEZorex0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec2025-07-01WarningsExact identifier
unii: 451W47IQ8X
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCd5b85158-b0d6-4855-9d07-8d1b3ad9ab712025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: B22547B95K
Nauzene Chewables Ginger HoneySODIUM CITRATEKobayashi Healthcare International, Inc.25c9825d-a4e8-4671-e063-6294a90ab46d2025-06-24WarningsExact identifier
unii: B22547B95K
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Calcium ChlorideCALCIUM CHLORIDE INJECTIONMedefil, Inc.90b8936e-61f2-5318-e053-2995a90aac442025-06-17Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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