{
"NDC": [
{
"NDCCode": "0093-7227-77",
"PackageDescription": "70 CAPSULE in 1 BOTTLE (0093-7227-77)",
"NDC11Code": "00093-7227-77",
"ProductNDC": "0093-7227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041004",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076277",
"LabelerName": "Teva Pharmaceuticals USA Inc",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "0093-7227-58",
"PackageDescription": "84 CAPSULE in 1 BOTTLE (0093-7227-58)",
"NDC11Code": "00093-7227-58",
"ProductNDC": "0093-7227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041004",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076277",
"LabelerName": "Teva Pharmaceuticals USA Inc",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "0093-7227-63",
"PackageDescription": "56 CAPSULE in 1 BOTTLE (0093-7227-63)",
"NDC11Code": "00093-7227-63",
"ProductNDC": "0093-7227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041004",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076277",
"LabelerName": "Teva Pharmaceuticals USA Inc",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "0093-7227-72",
"PackageDescription": "42 CAPSULE in 1 BOTTLE (0093-7227-72)",
"NDC11Code": "00093-7227-72",
"ProductNDC": "0093-7227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041004",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076277",
"LabelerName": "Teva Pharmaceuticals USA Inc",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "0093-0314-77",
"PackageDescription": "42328 TABLET, FILM COATED in 1 CONTAINER (0093-0314-77) ",
"NDC11Code": "00093-0314-77",
"ProductNDC": "0093-0314",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20241007",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-10-09",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "07-OCT-24"
},
{
"NDCCode": "0093-2607-77",
"PackageDescription": "116508 TABLET, FILM COATED in 1 CONTAINER (0093-2607-77) ",
"NDC11Code": "00093-2607-77",
"ProductNDC": "0093-2607",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20260313",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-03-16",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-MAR-26"
},
{
"NDCCode": "0093-2608-77",
"PackageDescription": "58248 TABLET, FILM COATED in 1 CONTAINER (0093-2608-77) ",
"NDC11Code": "00093-2608-77",
"ProductNDC": "0093-2608",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20260313",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-03-16",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-MAR-26"
},
{
"NDCCode": "0093-2609-77",
"PackageDescription": "29124 TABLET, FILM COATED in 1 CONTAINER (0093-2609-77) ",
"NDC11Code": "00093-2609-77",
"ProductNDC": "0093-2609",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20260313",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-03-16",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-MAR-26"
},
{
"NDCCode": "0093-3527-77",
"PackageDescription": "93024 TABLET, FILM COATED in 1 CONTAINER (0093-3527-77) ",
"NDC11Code": "00093-3527-77",
"ProductNDC": "0093-3527",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20260513",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-05-14",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-MAY-26"
},
{
"NDCCode": "0093-3528-77",
"PackageDescription": "46512 TABLET, FILM COATED in 1 CONTAINER (0093-3528-77) ",
"NDC11Code": "00093-3528-77",
"ProductNDC": "0093-3528",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20260513",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-05-14",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-MAY-26"
},
{
"NDCCode": "0093-3127-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0093-3127-01) ",
"NDC11Code": "00093-3127-01",
"ProductNDC": "0093-3127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Disopyramide Phosphate",
"NonProprietaryName": "Disopyramide Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070101",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DISOPYRAMIDE PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
"Description": "Disopyramide phosphate, USP is an antiarrhythmic drug available for oral administration in capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of disopyramide phosphate, USP is. C21H29N3OH3PO4 M.W. 437.47. α-[2-(diisopropylamino) ethyl]-α-phenyl-2-pyridineacetamide phosphate. Disopyramide phosphate, USP is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/mL. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Disopyramide phosphate, USP is a racemic mixture of d- and l-isomers. This drug is not chemically related to other antiarrhythmic drugs. Inactive Ingredients: lactose monohydrate, magnesium stearate and sodium starch glycolate. Capsule shell and ink ingredients: black iron oxide, D&C Red #28, D&C Red #33, D&C Yellow #10, FD&C Blue #1, gelatin, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "0093-3129-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0093-3129-01) ",
"NDC11Code": "00093-3129-01",
"ProductNDC": "0093-3129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Disopyramide Phosphate",
"NonProprietaryName": "Disopyramide Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070102",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DISOPYRAMIDE PHOSPHATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
"Description": "Disopyramide phosphate, USP is an antiarrhythmic drug available for oral administration in capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of disopyramide phosphate, USP is. C21H29N3OH3PO4 M.W. 437.47. α-[2-(diisopropylamino) ethyl]-α-phenyl-2-pyridineacetamide phosphate. Disopyramide phosphate, USP is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/mL. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Disopyramide phosphate, USP is a racemic mixture of d- and l-isomers. This drug is not chemically related to other antiarrhythmic drugs. Inactive Ingredients: lactose monohydrate, magnesium stearate and sodium starch glycolate. Capsule shell and ink ingredients: black iron oxide, D&C Red #28, D&C Red #33, D&C Yellow #10, FD&C Blue #1, gelatin, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "0093-5045-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5045-01) ",
"NDC11Code": "00093-5045-01",
"ProductNDC": "0093-5045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202731",
"LabelerName": "Teva Pharmaceuticals USA, 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": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170705",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3."
},
{
"NDCCode": "0093-5046-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5046-01) ",
"NDC11Code": "00093-5046-01",
"ProductNDC": "0093-5046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202731",
"LabelerName": "Teva Pharmaceuticals USA, 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": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170705",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3."
},
{
"NDCCode": "0093-5292-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5292-01) ",
"NDC11Code": "00093-5292-01",
"ProductNDC": "0093-5292",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "(cd)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078873",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120927",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.",
"Description": "Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1."
},
{
"NDCCode": "0093-5293-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5293-01) ",
"NDC11Code": "00093-5293-01",
"ProductNDC": "0093-5293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "(cd)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078873",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120927",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.",
"Description": "Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1."
},
{
"NDCCode": "0093-5295-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5295-01) ",
"NDC11Code": "00093-5295-01",
"ProductNDC": "0093-5295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
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"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077707",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
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"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.",
"Description": "Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1."
},
{
"NDCCode": "0093-5296-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5296-01) ",
"NDC11Code": "00093-5296-01",
"ProductNDC": "0093-5296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
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"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077707",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120927",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.",
"Description": "Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1."
},
{
"NDCCode": "0093-5297-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5297-01) ",
"NDC11Code": "00093-5297-01",
"ProductNDC": "0093-5297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "(cd)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077707",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120927",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.",
"Description": "Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1."
},
{
"NDCCode": "0093-5298-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5298-01) ",
"NDC11Code": "00093-5298-01",
"ProductNDC": "0093-5298",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "(cd)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078873",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120927",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.",
"Description": "Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1."
},
{
"NDCCode": "0093-5346-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5346-01) ",
"NDC11Code": "00093-5346-01",
"ProductNDC": "0093-5346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "(la)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079031",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120716",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].",
"Description": "Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows. M.W. 269.77. 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. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10."
},
{
"NDCCode": "0093-5347-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5347-01) ",
"NDC11Code": "00093-5347-01",
"ProductNDC": "0093-5347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "(la)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079031",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120716",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].",
"Description": "Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows. M.W. 269.77. 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. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10."
},
{
"NDCCode": "0093-5348-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5348-01) ",
"NDC11Code": "00093-5348-01",
"ProductNDC": "0093-5348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "(la)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079031",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120716",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].",
"Description": "Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows. M.W. 269.77. 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. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10."
},
{
"NDCCode": "0093-5550-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5550-01) ",
"NDC11Code": "00093-5550-01",
"ProductNDC": "0093-5550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078908",
"LabelerName": "Teva Pharmaceuticals USA, 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": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141110",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3."
},
{
"NDCCode": "0093-5551-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5551-01) ",
"NDC11Code": "00093-5551-01",
"ProductNDC": "0093-5551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078908",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-MAR-26</StartMarketingDatePackage>
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<NDC11Code>00093-2609-77</NDC11Code>
<ProductNDC>0093-2609</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20260313</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-16</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-MAR-26</StartMarketingDatePackage>
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<NDCCode>0093-3527-77</NDCCode>
<PackageDescription>93024 TABLET, FILM COATED in 1 CONTAINER (0093-3527-77) </PackageDescription>
<NDC11Code>00093-3527-77</NDC11Code>
<ProductNDC>0093-3527</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20260513</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-14</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-MAY-26</StartMarketingDatePackage>
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<NDC>
<NDCCode>0093-3528-77</NDCCode>
<PackageDescription>46512 TABLET, FILM COATED in 1 CONTAINER (0093-3528-77) </PackageDescription>
<NDC11Code>00093-3528-77</NDC11Code>
<ProductNDC>0093-3528</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20260513</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-14</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-MAY-26</StartMarketingDatePackage>
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<ProductNDC>0093-3127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Disopyramide Phosphate</ProprietaryName>
<NonProprietaryName>Disopyramide Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070101</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DISOPYRAMIDE PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
<Description>Disopyramide phosphate, USP is an antiarrhythmic drug available for oral administration in capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of disopyramide phosphate, USP is. C21H29N3OH3PO4 M.W. 437.47. α-[2-(diisopropylamino) ethyl]-α-phenyl-2-pyridineacetamide phosphate. Disopyramide phosphate, USP is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/mL. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Disopyramide phosphate, USP is a racemic mixture of d- and l-isomers. This drug is not chemically related to other antiarrhythmic drugs. Inactive Ingredients: lactose monohydrate, magnesium stearate and sodium starch glycolate. Capsule shell and ink ingredients: black iron oxide, D&C Red #28, D&C Red #33, D&C Yellow #10, FD&C Blue #1, gelatin, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
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<PackageDescription>100 CAPSULE in 1 BOTTLE (0093-3129-01) </PackageDescription>
<NDC11Code>00093-3129-01</NDC11Code>
<ProductNDC>0093-3129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Disopyramide Phosphate</ProprietaryName>
<NonProprietaryName>Disopyramide Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070102</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DISOPYRAMIDE PHOSPHATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
<Description>Disopyramide phosphate, USP is an antiarrhythmic drug available for oral administration in capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of disopyramide phosphate, USP is. C21H29N3OH3PO4 M.W. 437.47. α-[2-(diisopropylamino) ethyl]-α-phenyl-2-pyridineacetamide phosphate. Disopyramide phosphate, USP is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/mL. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Disopyramide phosphate, USP is a racemic mixture of d- and l-isomers. This drug is not chemically related to other antiarrhythmic drugs. Inactive Ingredients: lactose monohydrate, magnesium stearate and sodium starch glycolate. Capsule shell and ink ingredients: black iron oxide, D&C Red #28, D&C Red #33, D&C Yellow #10, FD&C Blue #1, gelatin, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0093-5045-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5045-01) </PackageDescription>
<NDC11Code>00093-5045-01</NDC11Code>
<ProductNDC>0093-5045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202731</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</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>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.</Description>
</NDC>
<NDC>
<NDCCode>0093-5046-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5046-01) </PackageDescription>
<NDC11Code>00093-5046-01</NDC11Code>
<ProductNDC>0093-5046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202731</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, 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>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.</Description>
</NDC>
<NDC>
<NDCCode>0093-5292-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5292-01) </PackageDescription>
<NDC11Code>00093-5292-01</NDC11Code>
<ProductNDC>0093-5292</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(cd)</ProprietaryNameSuffix>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078873</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120927</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>0093-5293-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5293-01) </PackageDescription>
<NDC11Code>00093-5293-01</NDC11Code>
<ProductNDC>0093-5293</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(cd)</ProprietaryNameSuffix>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078873</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120927</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>0093-5295-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5295-01) </PackageDescription>
<NDC11Code>00093-5295-01</NDC11Code>
<ProductNDC>0093-5295</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(cd)</ProprietaryNameSuffix>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077707</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, 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>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120927</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.</Description>
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<Description>Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.</Description>
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<Description>Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white 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. Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows. M.W. 269.77. 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. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows. M.W. 269.77. 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. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows. M.W. 269.77. 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. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10.</Description>
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<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
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<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
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<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.</Description>
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<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.</Description>
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<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.</Description>
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<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.</Description>
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<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is. C14H19NO2HCl M.W. 269.77. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.</Description>
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<IndicationAndUsage>Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride tablets contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Dexmethylphenidate hydrochloride tablet is a central nervous system (CNS) stimulant, available in 3 tablet strengths. Dexmethylphenidate hydrochloride tablet is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration. Chemically, dexmethylphenidate hydrochloride tablet is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note: * = asymmetric carbon centers. Dexmethylphenidate hydrochloride tablet is a white to off-white 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. Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and FD&C Blue No.1 aluminum lake (2.5 mg tablets), D&C Yellow Lake No. 10 (5 mg tablets); the 10 mg tablets contain no dye.</Description>
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