{
"NDC": {
"NDCCode": "81607-020-02",
"PackageDescription": "10 CARTON in 1 CARTON (81607-020-02) / 1 BLISTER PACK in 1 CARTON (81607-020-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE",
"NDC11Code": "81607-0020-02",
"ProductNDC": "81607-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Phytonadione",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20260324",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216298",
"LabelerName": "Orbicular Pharmaceutical Technologies Private Limited",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260324",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}