{
"NDC": [
{
"NDCCode": "70010-138-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (70010-138-01) ",
"NDC11Code": "70010-0138-01",
"ProductNDC": "70010-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074140",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210415",
"SamplePackage": "N"
},
{
"NDCCode": "70010-138-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (70010-138-05) ",
"NDC11Code": "70010-0138-05",
"ProductNDC": "70010-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074140",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210415",
"SamplePackage": "N"
},
{
"NDCCode": "70010-138-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70010-138-10) ",
"NDC11Code": "70010-0138-10",
"ProductNDC": "70010-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074140",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210415",
"SamplePackage": "N"
},
{
"NDCCode": "70010-001-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (70010-001-01) ",
"NDC11Code": "70010-0001-01",
"ProductNDC": "70010-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colchicine",
"NonProprietaryName": "Colchicine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210757",
"LabelerName": "Granules Pharmaceutical Inc.",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240429",
"SamplePackage": "N",
"IndicationAndUsage": "Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of use. The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.",
"Description": "Colchicine is an alkaloid obtained from the plant colchicum autumnale. The chemical name for colchicine is ( S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzol[a] heptalen-7-yl) acetamide. The structural formula is represented below:. C 22H 25NO 6 M.W. 399.4. Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether. Colchicine capsules are supplied for oral administration. Each capsule contains 0.6 mg Colchicine, USP and the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains ammonium hydroxide, FD&C Blue #1, ferrosoferric oxide, gelatin, propylene glycol, shellac, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "70010-002-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (70010-002-01) ",
"NDC11Code": "70010-0002-01",
"ProductNDC": "70010-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colchicine",
"NonProprietaryName": "Colchicine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210425",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200513",
"SamplePackage": "N"
},
{
"NDCCode": "70010-004-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-004-01) ",
"NDC11Code": "70010-0004-01",
"ProductNDC": "70010-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213813",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "70010-005-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-005-01) ",
"NDC11Code": "70010-0005-01",
"ProductNDC": "70010-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213813",
"LabelerName": "Granules Pharmaceuticals 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": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "70010-006-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-006-01) ",
"NDC11Code": "70010-0006-01",
"ProductNDC": "70010-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213813",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "70010-007-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-007-01) ",
"NDC11Code": "70010-0007-01",
"ProductNDC": "70010-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213813",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "70010-008-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-008-01) ",
"NDC11Code": "70010-0008-01",
"ProductNDC": "70010-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213813",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "70010-009-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-009-01) ",
"NDC11Code": "70010-0009-01",
"ProductNDC": "70010-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213813",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "70010-010-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-010-01) ",
"NDC11Code": "70010-0010-01",
"ProductNDC": "70010-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213813",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "70010-011-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-011-01) ",
"NDC11Code": "70010-0011-01",
"ProductNDC": "70010-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213813",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "70010-012-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-012-01) ",
"NDC11Code": "70010-0012-01",
"ProductNDC": "70010-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211796",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N"
},
{
"NDCCode": "70010-013-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-013-01) ",
"NDC11Code": "70010-0013-01",
"ProductNDC": "70010-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211796",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N"
},
{
"NDCCode": "70010-014-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-014-01) ",
"NDC11Code": "70010-0014-01",
"ProductNDC": "70010-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211796",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N"
},
{
"NDCCode": "70010-015-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-015-01) ",
"NDC11Code": "70010-0015-01",
"ProductNDC": "70010-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211796",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N"
},
{
"NDCCode": "70010-021-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-021-01) ",
"NDC11Code": "70010-0021-01",
"ProductNDC": "70010-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride Extended Release",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211797",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201022",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each extended-release tablet contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq, respectively of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, and titanium dioxide. In addition,10 mEq (750 mg) contains D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake and 8 mEq (600 mg) contains FD&C Blue No. 1 aluminum lake, FD&C Blue No.2 aluminum lake, and iron oxide yellow. FDA approved acceptance criteria for Sample preparation in the Assay differs from USP test. Meets USP Dissolution Test 6."
},
{
"NDCCode": "70010-022-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-022-01) ",
"NDC11Code": "70010-0022-01",
"ProductNDC": "70010-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride Extended Release",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211797",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201022",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each extended-release tablet contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq, respectively of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, and titanium dioxide. In addition,10 mEq (750 mg) contains D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake and 8 mEq (600 mg) contains FD&C Blue No. 1 aluminum lake, FD&C Blue No.2 aluminum lake, and iron oxide yellow. FDA approved acceptance criteria for Sample preparation in the Assay differs from USP test. Meets USP Dissolution Test 6."
},
{
"NDCCode": "70010-028-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (70010-028-01) ",
"NDC11Code": "70010-0028-01",
"ProductNDC": "70010-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramelteon",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213186",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"IndicationAndUsage": "Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].",
"Description": "Ramelteon is an orally active hypnotic chemically designated as ( S)- N-[2-(1,6,7,8-tetrahydro-2 H-indeno-[5,4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S)-enantiomer, with an empirical formula of C 16 H 21 NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "70010-029-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-029-01) ",
"NDC11Code": "70010-0029-01",
"ProductNDC": "70010-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217027",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "1.25; 1.25; 1.25; 1.25",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N",
"IndicationAndUsage": "N/A.",
"Description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze."
},
{
"NDCCode": "70010-030-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-030-01) ",
"NDC11Code": "70010-0030-01",
"ProductNDC": "70010-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217027",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "2.5; 2.5; 2.5; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N",
"IndicationAndUsage": "N/A.",
"Description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze."
},
{
"NDCCode": "70010-031-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-031-01) ",
"NDC11Code": "70010-0031-01",
"ProductNDC": "70010-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217027",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.75; 3.75; 3.75; 3.75",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N",
"IndicationAndUsage": "N/A.",
"Description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze."
},
{
"NDCCode": "70010-032-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-032-01) ",
"NDC11Code": "70010-0032-01",
"ProductNDC": "70010-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217027",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "5; 5; 5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N",
"IndicationAndUsage": "N/A.",
"Description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze."
},
{
"NDCCode": "70010-033-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-033-01) ",
"NDC11Code": "70010-0033-01",
"ProductNDC": "70010-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217027",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "6.25; 6.25; 6.25; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N",
"IndicationAndUsage": "N/A.",
"Description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze."
},
{
"NDCCode": "70010-034-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-034-01) ",
"NDC11Code": "70010-0034-01",
"ProductNDC": "70010-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217027",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N",
"IndicationAndUsage": "N/A.",
"Description": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze."
},
{
"NDCCode": "70010-040-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (70010-040-01) ",
"NDC11Code": "70010-0040-01",
"ProductNDC": "70010-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Sulfate",
"NonProprietaryName": "Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212619",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "AMPHETAMINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190815",
"SamplePackage": "N",
"IndicationAndUsage": "Amphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .",
"Description": "Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5 to 6. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1 aluminum lake. Structural Formula:."
},
{
"NDCCode": "70010-041-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (70010-041-01) ",
"NDC11Code": "70010-0041-01",
"ProductNDC": "70010-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Sulfate",
"NonProprietaryName": "Amphetamine Sulfate",
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"RouteName": "ORAL",
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"ApplicationNumber": "ANDA212619",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "AMPHETAMINE SULFATE",
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"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
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"IndicationAndUsage": "Amphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .",
"Description": "Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5 to 6. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1 aluminum lake. Structural Formula:."
},
{
"NDCCode": "70010-042-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-042-01) ",
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"ProductNDC": "70010-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181217",
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"ApplicationNumber": "ANDA210992",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
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"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
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"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets in adults and pediatric patients 6 years and older are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD), 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test."
},
{
"NDCCode": "70010-043-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-01) ",
"NDC11Code": "70010-0043-01",
"ProductNDC": "70010-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210992",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
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"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets in adults and pediatric patients 6 years and older are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD), 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test."
}
]
}
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<PackageDescription>100 TABLET in 1 BOTTLE (70010-138-01) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NDC>
<NDCCode>70010-001-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (70010-001-01) </PackageDescription>
<NDC11Code>70010-0001-01</NDC11Code>
<ProductNDC>70010-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Colchicine</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Granules Pharmaceutical Inc.</LabelerName>
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<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of use. The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.</IndicationAndUsage>
<Description>Colchicine is an alkaloid obtained from the plant colchicum autumnale. The chemical name for colchicine is ( S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzol[a] heptalen-7-yl) acetamide. The structural formula is represented below:. C 22H 25NO 6 M.W. 399.4. Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether. Colchicine capsules are supplied for oral administration. Each capsule contains 0.6 mg Colchicine, USP and the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains ammonium hydroxide, FD&C Blue #1, ferrosoferric oxide, gelatin, propylene glycol, shellac, titanium dioxide and yellow iron oxide.</Description>
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<NonProprietaryName>Colchicine</NonProprietaryName>
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<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
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<DEASchedule>CII</DEASchedule>
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<LastUpdate>2026-10-12</LastUpdate>
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<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<LastUpdate>2026-10-12</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDCCode>70010-007-01</NDCCode>
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<ProductNDC>70010-007</ProductNDC>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-008-01) </PackageDescription>
<NDC11Code>70010-0008-01</NDC11Code>
<ProductNDC>70010-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
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<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>70010-009-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-009-01) </PackageDescription>
<NDC11Code>70010-0009-01</NDC11Code>
<ProductNDC>70010-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>70010-010-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-010-01) </PackageDescription>
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<ProductNDC>70010-010</ProductNDC>
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<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213813</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70010-011-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-011-01) </PackageDescription>
<NDC11Code>70010-0011-01</NDC11Code>
<ProductNDC>70010-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213813</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70010-012-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-012-01) </PackageDescription>
<NDC11Code>70010-0012-01</NDC11Code>
<ProductNDC>70010-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211796</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70010-013-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-013-01) </PackageDescription>
<NDC11Code>70010-0013-01</NDC11Code>
<ProductNDC>70010-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211796</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70010-014-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-014-01) </PackageDescription>
<NDC11Code>70010-0014-01</NDC11Code>
<ProductNDC>70010-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211796</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70010-015-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-015-01) </PackageDescription>
<NDC11Code>70010-0015-01</NDC11Code>
<ProductNDC>70010-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211796</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70010-021-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-021-01) </PackageDescription>
<NDC11Code>70010-0021-01</NDC11Code>
<ProductNDC>70010-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride Extended Release</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211797</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each extended-release tablet contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq, respectively of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, and titanium dioxide. In addition,10 mEq (750 mg) contains D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake and 8 mEq (600 mg) contains FD&C Blue No. 1 aluminum lake, FD&C Blue No.2 aluminum lake, and iron oxide yellow. FDA approved acceptance criteria for Sample preparation in the Assay differs from USP test. Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>70010-022-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-022-01) </PackageDescription>
<NDC11Code>70010-0022-01</NDC11Code>
<ProductNDC>70010-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride Extended Release</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211797</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each extended-release tablet contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq, respectively of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, and titanium dioxide. In addition,10 mEq (750 mg) contains D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake and 8 mEq (600 mg) contains FD&C Blue No. 1 aluminum lake, FD&C Blue No.2 aluminum lake, and iron oxide yellow. FDA approved acceptance criteria for Sample preparation in the Assay differs from USP test. Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>70010-028-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70010-028-01) </PackageDescription>
<NDC11Code>70010-0028-01</NDC11Code>
<ProductNDC>70010-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramelteon</ProprietaryName>
<NonProprietaryName>Ramelteon</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213186</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RAMELTEON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Ramelteon is an orally active hypnotic chemically designated as ( S)- N-[2-(1,6,7,8-tetrahydro-2 H-indeno-[5,4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S)-enantiomer, with an empirical formula of C 16 H 21 NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70010-029-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-029-01) </PackageDescription>
<NDC11Code>70010-0029-01</NDC11Code>
<ProductNDC>70010-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217027</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.25; 1.25; 1.25; 1.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>N/A.</IndicationAndUsage>
<Description>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>70010-030-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-030-01) </PackageDescription>
<NDC11Code>70010-0030-01</NDC11Code>
<ProductNDC>70010-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217027</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>N/A.</IndicationAndUsage>
<Description>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>70010-031-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-031-01) </PackageDescription>
<NDC11Code>70010-0031-01</NDC11Code>
<ProductNDC>70010-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217027</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.75; 3.75; 3.75; 3.75</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>N/A.</IndicationAndUsage>
<Description>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze.</Description>
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<ProductNDC>70010-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
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<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
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<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
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<Description>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze.</Description>
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<NDC>
<NDCCode>70010-033-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-033-01) </PackageDescription>
<NDC11Code>70010-0033-01</NDC11Code>
<ProductNDC>70010-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
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<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217027</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>6.25; 6.25; 6.25; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>N/A.</IndicationAndUsage>
<Description>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>70010-034-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-034-01) </PackageDescription>
<NDC11Code>70010-0034-01</NDC11Code>
<ProductNDC>70010-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217027</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>N/A.</IndicationAndUsage>
<Description>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>70010-040-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70010-040-01) </PackageDescription>
<NDC11Code>70010-0040-01</NDC11Code>
<ProductNDC>70010-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212619</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .</IndicationAndUsage>
<Description>Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5 to 6. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1 aluminum lake. Structural Formula:.</Description>
</NDC>
<NDC>
<NDCCode>70010-041-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70010-041-01) </PackageDescription>
<NDC11Code>70010-0041-01</NDC11Code>
<ProductNDC>70010-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212619</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .</IndicationAndUsage>
<Description>Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5 to 6. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1 aluminum lake. Structural Formula:.</Description>
</NDC>
<NDC>
<NDCCode>70010-042-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-042-01) </PackageDescription>
<NDC11Code>70010-0042-01</NDC11Code>
<ProductNDC>70010-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210992</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets in adults and pediatric patients 6 years and older are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD), 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test.</Description>
</NDC>
<NDC>
<NDCCode>70010-043-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-01) </PackageDescription>
<NDC11Code>70010-0043-01</NDC11Code>
<ProductNDC>70010-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210992</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets in adults and pediatric patients 6 years and older are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD), 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test.</Description>
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