{
"NDC": {
"NDCCode": "64380-786-01",
"PackageDescription": "30 TABLET in 1 BOTTLE (64380-786-01) ",
"NDC11Code": "64380-0786-01",
"ProductNDC": "64380-786",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roflumilast",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221013",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208247",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "500",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221013",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}