{
"NDC": [
{
"NDCCode": "43602-178-25",
"PackageDescription": "250 mL in 1 BOTTLE (43602-178-25) ",
"NDC11Code": "43602-0178-25",
"ProductNDC": "43602-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207417",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "METHYLPHENIDATE",
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"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2021-02-20",
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"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
"Description": "Methylphenidate hydrochloride oral solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and 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. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP. In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: diluted hydrochloric acid, glycerin, polyethylene glycol, grape flavor and purified water."
},
{
"NDCCode": "43602-178-05",
"PackageDescription": "500 mL in 1 BOTTLE (43602-178-05) ",
"NDC11Code": "43602-0178-05",
"ProductNDC": "43602-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210129",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2021-02-20",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
"Description": "Methylphenidate hydrochloride oral solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and 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. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP. In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: diluted hydrochloric acid, glycerin, polyethylene glycol, grape flavor and purified water."
},
{
"NDCCode": "43602-177-25",
"PackageDescription": "250 mL in 1 BOTTLE (43602-177-25) ",
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"ProductNDC": "43602-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207417",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
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"Status": "Active",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210129",
"SamplePackage": "N",
"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
"Description": "Methylphenidate hydrochloride oral solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and 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. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP. In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: diluted hydrochloric acid, glycerin, polyethylene glycol, grape flavor and purified water."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "MORPHINE SULFATE",
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},
{
"NDCCode": "10019-178-68",
"PackageDescription": "25 AMPULE in 1 BOX (10019-178-68) > 1 mL in 1 AMPULE (10019-178-37)",
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"ProductNDC": "10019-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "MORPHINE SULFATE",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2015-11-23"
},
{
"NDCCode": "10738-178-25",
"PackageDescription": "63 mL in 1 TUBE (10738-178-25) ",
"NDC11Code": "10738-0178-25",
"ProductNDC": "10738-178",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triderma Essential Hand Sanitizer",
"NonProprietaryName": "Alcohol",
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"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Genuine Virgin Aloe Corporation",
"SubstanceName": "ALCOHOL",
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"Status": "Deprecated",
"LastUpdate": "2024-01-02",
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"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available. Recommended for repeated use."
},
{
"NDCCode": "15127-178-07",
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"ProductNDC": "15127-178",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
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"EndMarketingDate": "20210910",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "L&R Distributors, Inc.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
{
"NDCCode": "24196-178-00",
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"NDC11Code": "24196-0178-00",
"ProductNDC": "24196-178",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-JAN-15"
},
{
"NDCCode": "24909-170-25",
"PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (24909-170-25) * 14 g in 1 TUBE (24909-178-14) * 75 g in 1 CARTON (24909-176-75) ",
"NDC11Code": "24909-0170-25",
"ProductNDC": "24909-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Serious Tinea Treatment",
"NonProprietaryName": "Clotrimazole, Thuja Occidentalis",
"DosageFormName": "KIT",
"StartMarketingDate": "20170101",
"EndMarketingDate": "20250718",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"Status": "Deprecated",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170101",
"EndMarketingDatePackage": "20250718",
"SamplePackage": "N",
"IndicationAndUsage": "Ointment: Clears up tinea fungal infections including tinea corporis, tinea crursis, and tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections. Cleansing Bar: For most fungal infection."
},
{
"NDCCode": "35000-178-25",
"PackageDescription": "1 TUBE in 1 CARTON (35000-178-25) > 24.9 g in 1 TUBE",
"NDC11Code": "35000-0178-25",
"ProductNDC": "35000-178",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Total Sf Advanced Whitening",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20190514",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190514",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "52533-178-78",
"PackageDescription": "25 mL in 1 BAG (52533-178-78)",
"NDC11Code": "52533-0178-78",
"ProductNDC": "52533-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hcl",
"NonProprietaryName": "Promethazine Hcl",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140527",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cantrell Drug Company",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "53329-178-25",
"PackageDescription": "3790 mL in 1 BOTTLE, PLASTIC (53329-178-25)",
"NDC11Code": "53329-0178-25",
"ProductNDC": "53329-178",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cleanse",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150819",
"EndMarketingDate": "20181231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Medline Industries, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "62217-244-25",
"PackageDescription": "178 g in 1 CAN (62217-244-25) ",
"NDC11Code": "62217-0244-25",
"ProductNDC": "62217-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth Sun Town City Mineral Spf 30 Sunscreen",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Fruit Of The Earth, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "62217-249-25",
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"NDC11Code": "62217-0249-25",
"ProductNDC": "62217-249",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth Sun Town City Mineral Spf 50 Sunscreen",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20211007",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Fruit Of The Earth, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "35; 72.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20211007",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "62756-178-11",
"PackageDescription": "25 kg in 1 DRUM (62756-178-11) ",
"NDC11Code": "62756-0178-11",
"ProductNDC": "62756-178",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Unfinished",
"LastUpdate": "2026-01-20",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "14-JAN-21"
},
{
"NDCCode": "64220-178-08",
"PackageDescription": "25 kg in 1 DRUM (64220-178-08) ",
"NDC11Code": "64220-0178-08",
"ProductNDC": "64220-178",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dabigatran Etexilate Mesylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2021-02-03",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19-JUN-14"
},
{
"NDCCode": "64980-178-02",
"PackageDescription": "25 TABLET in 1 BOTTLE, PLASTIC (64980-178-02) ",
"NDC11Code": "64980-0178-02",
"ProductNDC": "64980-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chloroquine Phosphate",
"NonProprietaryName": "Chloroquine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090612",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CHLOROQUINE PHOSPHATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Chloroquine phosphate tablets are indicated for the: 1 Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax., 2 Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present., 3 Treatment of extraintestinal amebiasis.",
"Description": "Chloroquine phosphate tablets, USP, is a 4-aminoquinoline compound for oral administration. It is a white, odorless, bitter tasting, crystalline substance, freely soluble in water. Chloroquine phosphate tablets are an antimalarial and amebicidal drug. Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]quinoline phosphate (1:2) andhas the following structural formula. Each tablet contains 500 mg of chloroquine phosphate USP, equivalent to 300 mg chloroquine base. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate. The coating material contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "83602-178-25",
"PackageDescription": "25 BAG in 1 BOX (83602-178-25) / 1 PATCH in 1 BAG / 9 g in 1 PATCH",
"NDC11Code": "83602-0178-25",
"ProductNDC": "83602-178",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Knee Pain Relief Gel-patch",
"NonProprietaryName": "Lidocaine And Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260612",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.",
"SubstanceName": "LIDOCAINE; MENTHOL",
"StrengthNumber": ".04; .01",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260612",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows."
},
{
"NDCCode": "85248-178-01",
"PackageDescription": "25 VIAL in 1 CARTON (85248-178-01) / 5 mL in 1 VIAL",
"NDC11Code": "85248-0178-01",
"ProductNDC": "85248-178",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whisidom Saline Solution",
"NonProprietaryName": "Sodium Chloride 0.9% Saline Solution",
"DosageFormName": "LIQUID",
"RouteName": "NASAL",
"StartMarketingDate": "20260331",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Jiangxi Yudexi Pharmaceutical Co., LTD",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "Daily Personal Care."
},
{
"NDCCode": "43602-266-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-266-05) ",
"NDC11Code": "43602-0266-05",
"ProductNDC": "43602-266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212133",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
"Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
},
{
"NDCCode": "43602-266-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-266-30) ",
"NDC11Code": "43602-0266-30",
"ProductNDC": "43602-266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212133",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
"Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
},
{
"NDCCode": "43602-267-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-267-05) ",
"NDC11Code": "43602-0267-05",
"ProductNDC": "43602-267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212133",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
"Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
},
{
"NDCCode": "43602-267-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-267-30) ",
"NDC11Code": "43602-0267-30",
"ProductNDC": "43602-267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212133",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
"Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
},
{
"NDCCode": "43602-268-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-268-05) ",
"NDC11Code": "43602-0268-05",
"ProductNDC": "43602-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212133",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
"Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
},
{
"NDCCode": "43602-268-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-268-30) ",
"NDC11Code": "43602-0268-30",
"ProductNDC": "43602-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212133",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
"Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
},
{
"NDCCode": "43602-269-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-269-05) ",
"NDC11Code": "43602-0269-05",
"ProductNDC": "43602-269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212133",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "32",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
"Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
},
{
"NDCCode": "43602-269-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-269-30) ",
"NDC11Code": "43602-0269-30",
"ProductNDC": "43602-269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212133",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "32",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
"Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
},
{
"NDCCode": "43602-316-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-316-05) ",
"NDC11Code": "43602-0316-05",
"ProductNDC": "43602-316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
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<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15127-178-07</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (15127-178-07) > 25 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15127-0178-07</NDC11Code>
<ProductNDC>15127-178</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laxative</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020325</StartMarketingDate>
<EndMarketingDate>20210910</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>L&R Distributors, Inc.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20020325</StartMarketingDatePackage>
<EndMarketingDatePackage>20210910</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24196-178-00</NDCCode>
<PackageDescription>25 kg in 1 DRUM (24196-178-00) </PackageDescription>
<NDC11Code>24196-0178-00</NDC11Code>
<ProductNDC>24196-178</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Watson Pharma, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>24909-170-25</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (24909-170-25) * 14 g in 1 TUBE (24909-178-14) * 75 g in 1 CARTON (24909-176-75) </PackageDescription>
<NDC11Code>24909-0170-25</NDC11Code>
<ProductNDC>24909-170</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Serious Tinea Treatment</ProprietaryName>
<NonProprietaryName>Clotrimazole, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170101</StartMarketingDate>
<EndMarketingDate>20250718</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250718</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ointment: Clears up tinea fungal infections including tinea corporis, tinea crursis, and tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections. Cleansing Bar: For most fungal infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-178-25</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-178-25) > 24.9 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0178-25</NDC11Code>
<ProductNDC>35000-178</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Total Sf Advanced Whitening</ProprietaryName>
<NonProprietaryName>Stannous Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20190514</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>STANNOUS FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190514</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52533-178-78</NDCCode>
<PackageDescription>25 mL in 1 BAG (52533-178-78)</PackageDescription>
<NDC11Code>52533-0178-78</NDC11Code>
<ProductNDC>52533-178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hcl</ProprietaryName>
<NonProprietaryName>Promethazine Hcl</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140527</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cantrell Drug Company</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53329-178-25</NDCCode>
<PackageDescription>3790 mL in 1 BOTTLE, PLASTIC (53329-178-25)</PackageDescription>
<NDC11Code>53329-0178-25</NDC11Code>
<ProductNDC>53329-178</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cleanse</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride 0.13%</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<EndMarketingDate>20181231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Medline Industries, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>62217-244-25</NDCCode>
<PackageDescription>178 g in 1 CAN (62217-244-25) </PackageDescription>
<NDC11Code>62217-0244-25</NDC11Code>
<ProductNDC>62217-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth Sun Town City Mineral Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fruit Of The Earth, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-249-25</NDCCode>
<PackageDescription>178 g in 1 CAN (62217-249-25) </PackageDescription>
<NDC11Code>62217-0249-25</NDC11Code>
<ProductNDC>62217-249</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth Sun Town City Mineral Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211007</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fruit Of The Earth, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>35; 72.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62756-178-11</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62756-178-11) </PackageDescription>
<NDC11Code>62756-0178-11</NDC11Code>
<ProductNDC>62756-178</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-20</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-JAN-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64220-178-08</NDCCode>
<PackageDescription>25 kg in 1 DRUM (64220-178-08) </PackageDescription>
<NDC11Code>64220-0178-08</NDC11Code>
<ProductNDC>64220-178</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dabigatran Etexilate Mesylate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140619</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-02-03</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-JUN-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64980-178-02</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE, PLASTIC (64980-178-02) </PackageDescription>
<NDC11Code>64980-0178-02</NDC11Code>
<ProductNDC>64980-178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chloroquine Phosphate</ProprietaryName>
<NonProprietaryName>Chloroquine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090612</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CHLOROQUINE PHOSPHATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chloroquine phosphate tablets are indicated for the: 1 Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax., 2 Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present., 3 Treatment of extraintestinal amebiasis.</IndicationAndUsage>
<Description>Chloroquine phosphate tablets, USP, is a 4-aminoquinoline compound for oral administration. It is a white, odorless, bitter tasting, crystalline substance, freely soluble in water. Chloroquine phosphate tablets are an antimalarial and amebicidal drug. Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]quinoline phosphate (1:2) andhas the following structural formula. Each tablet contains 500 mg of chloroquine phosphate USP, equivalent to 300 mg chloroquine base. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate. The coating material contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>83602-178-25</NDCCode>
<PackageDescription>25 BAG in 1 BOX (83602-178-25) / 1 PATCH in 1 BAG / 9 g in 1 PATCH</PackageDescription>
<NDC11Code>83602-0178-25</NDC11Code>
<ProductNDC>83602-178</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Knee Pain Relief Gel-patch</ProprietaryName>
<NonProprietaryName>Lidocaine And Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260612</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>.04; .01</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85248-178-01</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (85248-178-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>85248-0178-01</NDC11Code>
<ProductNDC>85248-178</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whisidom Saline Solution</ProprietaryName>
<NonProprietaryName>Sodium Chloride 0.9% Saline Solution</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20260331</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Jiangxi Yudexi Pharmaceutical Co., LTD</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daily Personal Care.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43602-266-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-266-05) </PackageDescription>
<NDC11Code>43602-0266-05</NDC11Code>
<ProductNDC>43602-266</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212133</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>43602-266-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-266-30) </PackageDescription>
<NDC11Code>43602-0266-30</NDC11Code>
<ProductNDC>43602-266</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212133</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>43602-267-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-267-05) </PackageDescription>
<NDC11Code>43602-0267-05</NDC11Code>
<ProductNDC>43602-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
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<IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
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<IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
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<IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
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<IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
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<IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
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<IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
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<NDC11Code>43602-0316-05</NDC11Code>
<ProductNDC>43602-316</ProductNDC>
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<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
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<LastUpdate>2025-11-04</LastUpdate>
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<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1): 1 Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14), 2 Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14), 3 Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. (14).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: Sugar spheres, hydroxy propyl methyl cellulose, talc, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, hard gelatin capsules, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, iron oxide red. The 5 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin and sodium lauryl sulfate. The 10 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulfate and D&C Red 28. The 15 mg capsule shell contain Titanium dioxide, FD & C Blue 1, D & C Red 28, gelatin and sodium lauryl sulfate. The 20 mg capsule shell contain Titanium dioxide, FD & C Red 3, FD & C Yellow 6, FD & C Blue 1, gelatin, sodium lauryl sulfate and FD & C Red 40. The 25 mg capsule shell contain Titanium dioxide, FD & C Red 40, FD & C Yellow 6, gelatin, sodium lauryl sulfate. The 30 mg capsule shell contain Titanium dioxide, FD & C Yellow 6, D & C Yellow 10, sodium lauryl sulfate and gelatin. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide.</Description>
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<LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
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<Status>Deprecated</Status>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1): 1 Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14), 2 Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14), 3 Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. (14).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: Sugar spheres, hydroxy propyl methyl cellulose, talc, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, hard gelatin capsules, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, iron oxide red. The 5 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin and sodium lauryl sulfate. The 10 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulfate and D&C Red 28. The 15 mg capsule shell contain Titanium dioxide, FD & C Blue 1, D & C Red 28, gelatin and sodium lauryl sulfate. The 20 mg capsule shell contain Titanium dioxide, FD & C Red 3, FD & C Yellow 6, FD & C Blue 1, gelatin, sodium lauryl sulfate and FD & C Red 40. The 25 mg capsule shell contain Titanium dioxide, FD & C Red 40, FD & C Yellow 6, gelatin, sodium lauryl sulfate. The 30 mg capsule shell contain Titanium dioxide, FD & C Yellow 6, D & C Yellow 10, sodium lauryl sulfate and gelatin. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>43602-317-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-317-05) </PackageDescription>
<NDC11Code>43602-0317-05</NDC11Code>
<ProductNDC>43602-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214959</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1): 1 Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14), 2 Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14), 3 Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. (14).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: Sugar spheres, hydroxy propyl methyl cellulose, talc, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, hard gelatin capsules, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, iron oxide red. The 5 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin and sodium lauryl sulfate. The 10 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulfate and D&C Red 28. The 15 mg capsule shell contain Titanium dioxide, FD & C Blue 1, D & C Red 28, gelatin and sodium lauryl sulfate. The 20 mg capsule shell contain Titanium dioxide, FD & C Red 3, FD & C Yellow 6, FD & C Blue 1, gelatin, sodium lauryl sulfate and FD & C Red 40. The 25 mg capsule shell contain Titanium dioxide, FD & C Red 40, FD & C Yellow 6, gelatin, sodium lauryl sulfate. The 30 mg capsule shell contain Titanium dioxide, FD & C Yellow 6, D & C Yellow 10, sodium lauryl sulfate and gelatin. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide.</Description>
</NDC>
</NDCList>