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 47 of 53 · 1,046 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.24a08a93-df23-474b-873e-c59ec8855f9f2022-03-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Wild Horse 777 Moisturizing NasalSODIUM CHLORIDEWild Horse 777, Inc.b0b4dadd-11fa-3dbb-e053-2995a90a20972022-03-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.cc14fafd-3dcd-4fc8-bdbd-6f355c3757682022-02-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC8b44bfd3-70a4-4b47-bc7b-590f63b8cc752022-02-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCf62481fd-fcdb-4be6-ac13-29c590e925c32022-02-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.e44c41ae-c9c8-4dd8-ba6c-cebb585378aa2022-01-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist WalgreensSODIUM CHLORIDEWALGREEN COMPANYd6b9d4fc-b758-be32-e053-2995a90a25232022-01-29WarningsExact identifier
unii: 451W47IQ8X
Extra Strenght Saline Mist Rite AidSODIUM CHLORIDERITE AID CORPORATIONd5b30fb2-4052-4a0c-e053-2a95a90aacd52022-01-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist Rite AidSODIUM CHLORIDERITE AIDd583067e-1133-7d7d-e053-2a95a90a1e362022-01-13WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline MistSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC648da2bc-bc91-4295-9e46-d3055cdc24182022-01-08WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Nasal DripSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5129a91-50e7-6b94-e053-2a95a90a2b302022-01-08WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline Mist Daily CareSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5131ab2-8213-3659-e053-2a95a90ab2ab2022-01-08WarningsExact identifier
unii: 451W47IQ8X
BHI HemorrhoidHORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFURMediNatura Incd7df7d3e-48ad-4f58-aef5-a7bd48d2f1912022-01-05WarningsExact identifier
unii: QTT17582CB
Headek NasalBELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics976b9c85-68c9-46a5-9012-53cb24683b032021-12-29WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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