FDA.reportPublic FDA data

NDC 13533-605 - THROMBATE III

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
13533-605
Package NDCs from labels
13533-605-21
Manufacturer
GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA
Effective date
2025-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alanine - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2025-08-21PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-605THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC]29Unmatched20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Antithrombin Iii HumanACTIVE INGREDIENTT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Antithrombin Iii HumanACTIVE MOIETYT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]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 5 of 52 · 1,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d2c34e-fa4d-9240-e063-6294a90a28da2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFTotal Operations Management LLC DBA:Bestmade Natural Products Micro53d48847-c0bf-1334-e063-6294a90acf7e2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53d52b7e-1e84-d4d3-e063-6294a90a9efc2026-06-09WarningsExact identifier
unii: 451W47IQ8X
ApizelenGERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUMBioActive Nutritional, Inc.471a7fab-1ef1-4d13-a28e-75f9762a711a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
BM Nat MurNATRIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53baa9ce-5ce6-7bba-e063-6294a90a517a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: OF5P57N2ZX
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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