<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70121-2715-2
</NDCCode>
<PackageDescription>
10 AMPULE in 1 BOX (70121-2715-2) / 10 mL in 1 AMPULE (70121-2715-3)
</PackageDescription>
<NDC11Code>
70121-2715-02
</NDC11Code>
<ProductNDC>
70121-2715
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Methylene Blue
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Methylene Blue
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250303
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA216955
</ApplicationNumber>
<LabelerName>
Amneal Pharmaceuticals LLC
</LabelerName>
<SubstanceName>
METHYLENE BLUE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250303
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>