FDA.reportPublic FDA data

NDC 61364-181-01 - Rapivab

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
61364-181
Requested NDC
61364-181-01
Package NDCs from labels
61364-181-01, 61364-181-03
Manufacturer
Seqirus USA Inc. | Alcami Missouri Corporation | Cilag Ag | Eurofins Lancaster Laboratories Inc. | Galbraith Labs Inc. | Jubilant HollisterStier LLC | Patheon Manufacturing Services LLC | Siegfried USA, LLC
Effective date
2020-06-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RapivabSeqirus USA Inc. | Alcami Missouri Corporation | Cilag Ag | Eurofins Lancaster Laboratories Inc. | Galbraith Labs Inc. | Jubilant HollisterStier LLC | Patheon Manufacturing Services LLC | Siegfried USA, LLC2020-06-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61364-181-032021-07-23C16284748780-1c7ccaba7-0ff0-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use RAPIVAB safely and effectively. See full prescribing information for RAPIVAB. RAPIVAB ® (peramivir injection), for intravenous use Initial U.S. Approval: [2014]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61364-181-01Rapivab20 mL in 1 VIAL, GLASSSOLUTION207
61364-181-03Rapivab3 in 1 CARTONSOLUTION37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61364-181RAPIVAB (PERAMIVIR) SOLUTION [SEQIRUS USA INC.]7Legacy NDC, 2 package rows20200626_7fdedaec-9e53-4a37-a4e4-a301c8a251b8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61364-181-01ML - Milliliter61364-18166173613-ff45-49b6-bb5f-bf3cd2a7049412015-01-05
61364-181-03ML - Milliliter61364-181929831d0-4474-4b87-9a3a-7b79a9b3310112015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PeramivirACTIVE INGREDIENTQW7Y7ZR15URAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.]2
Peramivir AnhydrousACTIVE MOIETY9ZS94HQO3BRAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBRAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XRAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IRAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RRAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.]2

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 44 of 53 · 1,046 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 451W47IQ8X
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86463b98-58f5-7f65-e053-2a91aa0ad3a22023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645f130-6a19-ae73-e053-2991aa0ab05b2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645eb60-65d1-9d6c-e053-2991aa0a94ef2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0e6-5c06-e053-2a91aa0ae83d2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466614-b8ee-2335-e053-2a91aa0aa67c2023-01-23Exact identifier
unii: 451W47IQ8X
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
PSORIASISARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMZorex Internationalb5b8bb82-4d36-4faa-b023-e48066f4521c2023-01-09WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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