{
"NDC": {
"NDCCode": "43598-627-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (43598-627-30) ",
"NDC11Code": "43598-0627-30",
"ProductNDC": "43598-627",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine And Topiramate Extended-release",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Phentermine And Topiramate Extended-release",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250601",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208175",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE; TOPIRAMATE",
"StrengthNumber": "15; 92",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}