{
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"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-236-31) ",
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"ProductNDC": "66758-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
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"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251216",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}