{
"NDC": [
{
"NDCCode": "68788-4020-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (68788-4020-6) ",
"NDC11Code": "68788-4020-06",
"ProductNDC": "68788-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250829",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 NNaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5mg and 10 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "57955-4020-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-4020-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-4020-01",
"ProductNDC": "57955-4020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Irritable Bowelcare",
"NonProprietaryName": "Aloe Socotrina, Carbo Vegetabilis, Chamomilla, Cinchona Officinalis, Collinsonia Canadensis, Colocynthis, Croton Tiglium, Gelsemium Sempervirens, Gratiola Officinalis, Nux Vomica,phosphoricum Acidum, Podophyllum Peltatum And Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110213",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALOE; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; GELSEMIUM SEMPERVIRENS ROOT; GRATIOLA OFFICINALIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; mL/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68071-4020-6",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-4020-6)",
"NDC11Code": "68071-4020-06",
"ProductNDC": "68071-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076159",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "68788-4020-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (68788-4020-1) ",
"NDC11Code": "68788-4020-01",
"ProductNDC": "68788-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250829",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 NNaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5mg and 10 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "68788-4020-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68788-4020-3) ",
"NDC11Code": "68788-4020-03",
"ProductNDC": "68788-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250829",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 NNaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5mg and 10 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "68788-4020-8",
"PackageDescription": "180 TABLET in 1 BOTTLE (68788-4020-8) ",
"NDC11Code": "68788-4020-08",
"ProductNDC": "68788-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250829",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 NNaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5mg and 10 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "68788-4020-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (68788-4020-9) ",
"NDC11Code": "68788-4020-09",
"ProductNDC": "68788-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250829",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 NNaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5mg and 10 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "0186-4020-01",
"PackageDescription": "30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4020-01) ",
"NDC11Code": "00186-4020-01",
"ProductNDC": "0186-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "GRANULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070319",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021957",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070319",
"SamplePackage": "N",
"IndicationAndUsage": "NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red #28, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate)."
},
{
"NDCCode": "42858-075-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-075-45) ",
"NDC11Code": "42858-0075-45",
"ProductNDC": "42858-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "42858-076-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-076-45) ",
"NDC11Code": "42858-0076-45",
"ProductNDC": "42858-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "42858-077-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-077-45) ",
"NDC11Code": "42858-0077-45",
"ProductNDC": "42858-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "42858-078-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-078-45) ",
"NDC11Code": "42858-0078-45",
"ProductNDC": "42858-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "42858-079-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-079-45) ",
"NDC11Code": "42858-0079-45",
"ProductNDC": "42858-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "42858-080-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-080-45) ",
"NDC11Code": "42858-0080-45",
"ProductNDC": "42858-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "42858-081-45",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-081-45) ",
"NDC11Code": "42858-0081-45",
"ProductNDC": "42858-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205831",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide."
},
{
"NDCCode": "48951-4020-3",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (48951-4020-3) ",
"NDC11Code": "48951-4020-03",
"ProductNDC": "48951-4020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Echinacea Quartz",
"NonProprietaryName": "Echinacea Quartz",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy, Inc.",
"SubstanceName": "ANTIMONY TRISULFIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; SILICON DIOXIDE; SILVER",
"StrengthNumber": "6; 20; 3; 20; 20",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "50090-4020-0",
"PackageDescription": "1 TUBE in 1 CARTON (50090-4020-0) / 100 g in 1 TUBE",
"NDC11Code": "50090-4020-00",
"ProductNDC": "50090-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209903",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190104",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (1): 1 Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder. (14.1).",
"Description": "Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. The chemical name is 2-[(2,6-dichlorophenyl) amino]benzene-acetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following chemical structure. It contains the active ingredient, diclofenac sodium, USP in an opaque, white gel base. Diclofenac sodium, USP is a white to off-white, amorphous, crystalline powder. Diclofenac sodium is a benzeneacetic acid derivative. The inactive ingredients in diclofenac sodium topical gel include: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution."
},
{
"NDCCode": "53002-4020-1",
"PackageDescription": "5 TABLET in 1 BOTTLE (53002-4020-1) ",
"NDC11Code": "53002-4020-01",
"ProductNDC": "53002-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "53002-4020-2",
"PackageDescription": "10 TABLET in 1 BOTTLE (53002-4020-2) ",
"NDC11Code": "53002-4020-02",
"ProductNDC": "53002-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "53002-4020-3",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-4020-3) ",
"NDC11Code": "53002-4020-03",
"ProductNDC": "53002-4020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "68788-0005-6",
"PackageDescription": "60 TABLET in 1 BOTTLE, DISPENSING (68788-0005-6) ",
"NDC11Code": "68788-0005-06",
"ProductNDC": "68788-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077032",
"LabelerName": "Preferred Pharmaceuticals, Inc",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110209",
"SamplePackage": "N"
},
{
"NDCCode": "68788-0007-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (68788-0007-6) ",
"NDC11Code": "68788-0007-06",
"ProductNDC": "68788-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077534",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20141017",
"SamplePackage": "N"
},
{
"NDCCode": "68788-0012-1",
"PackageDescription": "6 POUCH in 1 CARTON (68788-0012-1) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL",
"NDC11Code": "68788-0012-01",
"ProductNDC": "68788-0012",
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red #28, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
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<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-075-45) </PackageDescription>
<NDC11Code>42858-0075-45</NDC11Code>
<ProductNDC>42858-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA205831</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide.</Description>
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<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-076-45) </PackageDescription>
<NDC11Code>42858-0076-45</NDC11Code>
<ProductNDC>42858-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA205831</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</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>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide.</Description>
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<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-077-45) </PackageDescription>
<NDC11Code>42858-0077-45</NDC11Code>
<ProductNDC>42858-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA205831</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide.</Description>
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<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-078-45) </PackageDescription>
<NDC11Code>42858-0078-45</NDC11Code>
<ProductNDC>42858-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA205831</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
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<ApplicationNumber>NDA205831</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
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<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>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide.</Description>
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<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Blue No. 115 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 4020 mg: D&C Red No. 33, D&C Yellow No. 1030 mg: FD&C Blue No. 1, FD&C Red No. 340 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 4050 mg: D&C Yellow No. 10, FD&C Green No. 360 mg: Black Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>48951-4020-3</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (48951-4020-3) </PackageDescription>
<NDC11Code>48951-4020-03</NDC11Code>
<ProductNDC>48951-4020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Echinacea Quartz</ProprietaryName>
<NonProprietaryName>Echinacea Quartz</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy, Inc.</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; SILICON DIOXIDE; SILVER</SubstanceName>
<StrengthNumber>6; 20; 3; 20; 20</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-4020-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50090-4020-0) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>50090-4020-00</NDC11Code>
<ProductNDC>50090-4020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209903</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (1): 1 Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder. (14.1).</IndicationAndUsage>
<Description>Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. The chemical name is 2-[(2,6-dichlorophenyl) amino]benzene-acetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following chemical structure. It contains the active ingredient, diclofenac sodium, USP in an opaque, white gel base. Diclofenac sodium, USP is a white to off-white, amorphous, crystalline powder. Diclofenac sodium is a benzeneacetic acid derivative. The inactive ingredients in diclofenac sodium topical gel include: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>53002-4020-1</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (53002-4020-1) </PackageDescription>
<NDC11Code>53002-4020-01</NDC11Code>
<ProductNDC>53002-4020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>53002-4020-2</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (53002-4020-2) </PackageDescription>
<NDC11Code>53002-4020-02</NDC11Code>
<ProductNDC>53002-4020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>53002-4020-3</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-4020-3) </PackageDescription>
<NDC11Code>53002-4020-03</NDC11Code>
<ProductNDC>53002-4020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>68788-0005-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, DISPENSING (68788-0005-6) </PackageDescription>
<NDC11Code>68788-0005-06</NDC11Code>
<ProductNDC>68788-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077032</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-0007-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-0007-6) </PackageDescription>
<NDC11Code>68788-0007-06</NDC11Code>
<ProductNDC>68788-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077534</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-0012-1</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (68788-0012-1) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>68788-0012-01</NDC11Code>
<ProductNDC>68788-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Budesonide</ProprietaryName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20090204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077519</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-0013-1</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (68788-0013-1) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>68788-0013-01</NDC11Code>
<ProductNDC>68788-0013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Budesonide</ProprietaryName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20090204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077519</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-0046-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-0046-6)</PackageDescription>
<NDC11Code>68788-0046-06</NDC11Code>
<ProductNDC>68788-0046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073589</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>68788-0048-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-0048-6) </PackageDescription>
<NDC11Code>68788-0048-06</NDC11Code>
<ProductNDC>68788-0048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090467</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-0053-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68788-0053-6) </PackageDescription>
<NDC11Code>68788-0053-06</NDC11Code>
<ProductNDC>68788-0053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074253</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-0074-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-0074-6) </PackageDescription>
<NDC11Code>68788-0074-06</NDC11Code>
<ProductNDC>68788-0074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075828</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-0141-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-0141-6) </PackageDescription>
<NDC11Code>68788-0141-06</NDC11Code>
<ProductNDC>68788-0141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075795</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68788-0142-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-0142-6) </PackageDescription>
<NDC11Code>68788-0142-06</NDC11Code>
<ProductNDC>68788-0142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075795</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2.</Description>
</NDC>
</NDCList>