<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42677-326-01
</NDCCode>
<PackageDescription>
1 BOTTLE, GLASS in 1 CARTON (42677-326-01) / 100 mL in 1 BOTTLE, GLASS
</PackageDescription>
<NDC11Code>
42677-0326-01
</NDC11Code>
<ProductNDC>
42677-326
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Isoflurane
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Isoflurane
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
RESPIRATORY (INHALATION)
</RouteName>
<StartMarketingDate>
20251104
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA216527
</ApplicationNumber>
<LabelerName>
Shandong New Time Pharmaceutical Co., Ltd.
</LabelerName>
<SubstanceName>
ISOFLURANE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mL/100mL
</StrengthUnit>
<Pharm_Classes>
General Anesthesia [PE], General Anesthetic [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251104
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>