<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81284-315-05
</NDCCode>
<PackageDescription>
5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00)
</PackageDescription>
<NDC11Code>
81284-0315-05
</NDC11Code>
<ProductNDC>
81284-315
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Bludigo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Indigotindisulfonate Sodium
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20220906
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA216264
</ApplicationNumber>
<LabelerName>
Provepharm Inc.
</LabelerName>
<SubstanceName>
INDIGOTINDISULFONATE SODIUM
</SubstanceName>
<StrengthNumber>
8
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Diagnostic Dye [EPC], Dyes [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-13
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220906
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>