NDC 13533-702 - PROLASTIN-C

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: 13533-702
Package NDCs from labels: 13533-702-11
Manufacturer: GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA
Effective date: 2022-02-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13533-702-11	PROLASTIN-C	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20 mL	1000 mg in 20mL	25
13533-702-11	PROLASTIN-C	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20 mL	1000 mg in 20mL	25
13533-702-11	PROLASTIN-C	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20 mL	1000 mg in 20mL	25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13533-702	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

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

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 36 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Weed Grass Antigens	ALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,	Energique, Inc.	8a28f56a-6010-42e3-b360-e6e22b86222a	2024-05-02	Warnings	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	c2467d57-cd2d-4409-bcc0-50128bd01bba	2024-04-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Mineffect eye drops	ALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM	Kadesh Incoporation Co,Ltd	e2259f58-3043-4af3-918d-d4403757aa1f	2024-04-26	Warnings	Exact identifier unii: 451W47IQ8X
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Fresenius Kabi USA, LLC	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	2024-04-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	c1e52670-c85e-4f19-a2e9-bf9abd7c3727	2024-04-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
PEMF Optimizer	AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM	Deseret Biologicals, Inc.	97d57469-4c5b-4d3f-9398-3a1a6617a649	2024-04-23	Warnings	Exact identifier unii: 059QF0KO0R
Dermapar	EPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUM	Energique, Inc.	f79fe29b-341e-4bee-9665-1805a7157d1a	2024-04-22	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	78ef7ad3-451d-43d0-a9b6-5cf0aadca003	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Hikma Pharmaceuticals USA Inc.	e5ee8caa-b6ca-45ba-98fb-8305e6282141	2024-04-10	Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	B. Braun Medical Inc.	8fc8d87a-3951-4ac5-97df-c161ffc90475	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Hers Plus	CALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALIS	Deseret Biologicals,Inc.	e4636b80-f6c8-459c-8d0e-ff7801358b10	2024-04-09	Warnings	Exact identifier unii: 451W47IQ8X
Dextrose And Sodium Chloride	DEXTROSE AND SODIUM CHLORIDE	B. Braun Medical Inc.	8e6569ce-9714-497f-a94b-c6975c1d76f6	2024-04-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
SINU HC	PLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUM	Deseret Biologicals, Inc.	8b63e066-dd1b-4aee-a17b-4edc6b71a1cc	2024-04-02	Warnings	Exact identifier unii: 451W47IQ8X
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier unii: 059QF0KO0R
CVS Health Sterile Saline Mist	SODIUM CHLORIDE	CVS Pharmacy	14931004-1efb-e331-e063-6294a90ad66e	2024-03-26	Warnings	Exact identifier unii: 451W47IQ8X
Aqua marina	SODIUM CHLORIDE	Boiron	14945760-30b5-27d3-e063-6394a90a8a32	2024-03-26		Exact identifier unii: 451W47IQ8X
Headache HP	BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM	Energique, Inc.	5dca8670-c931-47e3-af89-b5f09f5f4e02	2024-03-26	Warnings	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	59ccc717-c374-41c0-be58-9647df881160	2024-03-26	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
V-Fem Care	AGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELIS	Newton Laboratories, Inc.	14800c19-e5c6-924b-e063-6394a90a15e5	2024-03-25	Warnings	Exact identifier unii: 451W47IQ8X
Control	ANACARDIUM ORIENTALE, AQUA MARINA, ARGENTUM NITRICUM, ASARUM CANADENSE, BLATTA ORIENTALIS, BUFO RANA, CEREBRUM SUIS, CLEMATIS ERECTA, CUPRUM ACETICUM, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PLACENTA TOTALIS SUIS, RHUS TOX, THUJA OCCIDENTALIS, THYMOLUM, VALERIANA OFFICINALIS	Deseret Biologicals, Inc.	9daec04d-44fb-4d0f-8e21-1109f515eb5d	2024-03-25	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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