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 32 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Licefreee Everyday	SODIUM CHLORIDE	Tec Laboratories,Inc.	407b5fd6-2331-2ba7-e054-00144ff88e88	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Licefreee	HEAD LICE TREATMENT	Tec Laboratories, Inc.	08c9d3dd-7177-0148-e054-00144ff8d46c	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Bladder Relief	CAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS	Magni Company	5d0db70c-6360-493b-bcf2-8dbc95314140	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Vaccines	ARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENS	Liddell Laboratories, Inc.	6e6e67d4-089e-4775-b4a4-5511953f6e3f	2024-11-04	Warnings	Exact identifier unii: 451W47IQ8X
Gluten Detox	BARLEY (GRAIN), CARBO VEGETABILIS, CINCHONA OFFICINALIS, GLUTEN, GLYPHOSATE, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PANCREAS SUIS, PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN)	Liddell Laboratories, Inc.	706f2e33-8674-4911-ba0a-4efc935e7739	2024-11-04	Warnings	Exact identifier unii: 451W47IQ8X
Derma Pain	CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)	Liddell Laboratories, Inc.	e02a5e99-aa27-4276-a785-7b5328d89fdc	2024-11-04	Warnings	Exact identifier unii: 451W47IQ8X
Vaccistat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUM	Energique, Inc.	8c8d63b6-763a-44f8-87ef-e83a89ec3776	2024-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Vaccistat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUM	Energique, Inc.	5205cc3e-c9bc-48e9-9c9b-959a9be78b85	2024-10-31	Warnings	Exact identifier unii: 451W47IQ8X
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.	0ec09d62-07ca-4bbe-9019-1025f5713211	2024-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Thyroid Tonic	ACACIA ARABICA, OLEUM OLEA EUROPAEA, SESAME OIL, FUCUS VESICULOSUS 3X, IODIUM, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAGE OIL, CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), HYDROFLUORICUM ACIDUM	Energique, Inc.	aeca8e0e-12e6-44d0-a709-401d137f7cf3	2024-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Spleenpar	SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS	Energique, Inc.	f89581c5-faab-42b2-b984-e369f6ff8b49	2024-10-30	Warnings	Exact identifier unii: 451W47IQ8X
Muscle/Tendon Pain and Stress Relief	CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)	Energique, Inc.	4a8f73ab-77af-4556-8bf2-96b5f5d3fb8f	2024-10-29	Warnings	Exact identifier unii: 451W47IQ8X
Nat Mur	NATRUM MURIATICUM	Energique, Inc.	39c4cb25-e70f-4d5a-b7b6-1b62527aa4f3	2024-10-29	Warnings	Exact identifier unii: 451W47IQ8X
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Fresenius Kabi USA, LLC	68cc9c41-ed24-4f76-8efb-2936ae3ddd8d	2024-10-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Psora Miasm	EGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, FAGOPYRUM ESCULENTUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUM	Energique, Inc.	d008a091-b7c6-41f1-a1cf-f8224ebe55e5	2024-10-29	Warnings	Exact identifier unii: 451W47IQ8X
Multi-Cell Salt	KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEA	Energique, Inc.	dad00225-b3ac-4e36-a856-19b0faf42c42	2024-10-29	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.	38fd4f98-a42a-435b-9643-16df66453951	2024-10-29	Warnings	Exact identifier unii: 451W47IQ8X
DERMATOME HP	LYCOPODICUM CLAVATUM, MEZEREUM, NATRUM MURIATICUM,	Energique, Inc.	54a096ac-7ebe-4565-b1b0-0473de16e70c	2024-10-24	Warnings	Exact identifier unii: 451W47IQ8X
Complexion HP	CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM	Energique, Inc.	ad12d51e-04cb-4833-b802-0038796966ff	2024-10-24	Warnings	Exact identifier unii: 451W47IQ8X
CV HP	ADONIS VERNALIS, LACHESIS MUTUS, LYCOPUS VIRGINICUS, VALERIANA OFFICINALIS, AURUM METALLICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS),	ENERGIQUE, INC.	c06763c5-8bde-4251-bd41-67becf8ce8c4	2024-10-24	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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