NDC 13533-000 - 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: 13533-000
Package NDCs from labels: 13533-000-05, 13533-000-04, 13533-000-06
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
Label	Manufacturer	Effective date	Type
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
13533-000	THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC]	29	Unmatched	20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip
13533-000	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
13533-000	KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]	23	Unmatched	20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip
13533-000	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 8 of 54 · 1,064 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	e13fd053-9420-490c-a43e-e14b0930cb4e	2026-03-18	Warnings	Exact identifier unii: 451W47IQ8X
Universaltox	ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUM	BioActive Nutritional, Inc.	ad454e8a-4f78-4aac-90d9-a3f26a6fbe42	2026-03-17	Warnings	Exact identifier unii: 451W47IQ8X
TINTED SUNSCREEN FOUNDATION	TINTED SUNSCREEN FOUNDATION	Guanghzou AiXin Biotech Co Ltd	396393c4-b50c-3877-e063-6294a90a0e9b	2026-03-17	Warnings	Exact identifier unii: 059QF0KO0R
BM BIO27	CALC PHOS, KALI PHOS, NAT MUR	BM Private Limited	4d229815-05f4-27c5-e063-6394a90ac865	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
BM BIO1	CALC PHOS, FERR PHOS, KALI PHOS, NAT MUR	BM Private Limited	4d265d99-fdbb-5efb-e063-6394a90a89ac	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
BM BIO16	CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.	BM Private Limited	4d26b4a9-ee27-6915-e063-6294a90a5d4d	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
BM BIO12	FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.	BM Private Limited	4d2747ad-958e-63a1-e063-6294a90aea66	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
RESP EASE	SODIUM CHLORIDE	Venture Healthcare Ltd	31b812c9-fb0a-5ee0-e063-6294a90a03e1	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
RESP EASE	SODIUM CHLORIDE	Venture Healthcare Ltd	31b88e7c-eca0-5540-e063-6294a90a1b18	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
RESP EASE	SODIUM CHLORIDE	Venture Healthcare Ltd	31b8c3f4-e528-c69d-e063-6294a90a5a34	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
RESP EASE	SODIUM CHLORIDE	Laboratoire Unither	31b7eb13-39c3-6f0e-e063-6394a90a4011	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
RESP EASE	SODIUM CHLORIDE	Laboratoire Unither	31b8bb9c-d30f-152f-e063-6394a90a5208	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
RESP EASE	SODIUM CHLORIDE	Laboratoire Unither	31b8dcbd-9e6b-1edc-e063-6394a90aac73	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
BM BIO20	CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULF	BM Private Limited	4d285396-9df8-86bc-e063-6294a90ad4de	2026-03-16	Warnings	Exact identifier unii: 451W47IQ8X
HZ HP	LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, RHUS TOX, SEPIA, THUJA OCCIDENTALIS	BioActive Nutritional, Inc.	b662dea8-4eb5-4c80-a5ab-7d3688732773	2026-03-13	Warnings	Exact identifier unii: 451W47IQ8X
Drop20	FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)	Pick Enterprises Corp	baa96813-dc95-472e-a834-880a0cd484a7	2026-03-13	Warnings	Exact identifier unii: 451W47IQ8X
Appetrol 20	FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)	Carbalor LLC	d66234a3-2477-42be-8f7b-283e3a5f87ed	2026-03-12	Warnings	Exact identifier unii: 451W47IQ8X
Constitutional Enhancer	ACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.	King Bio Inc.	448becd7-58aa-40ae-9b4b-39f48a8f13dd	2026-03-10	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	018a8807-1331-41c3-4889-c7ec502a9043	2026-03-09	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c7f645-cfb3-6db1-e063-6394a90a42ff	2026-03-06	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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