{
"NDC": [
{
"NDCCode": "52536-510-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-510-01) ",
"NDC11Code": "52536-0510-01",
"ProductNDC": "52536-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090533",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120720",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) 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. .",
"Description": "Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49."
},
{
"NDCCode": "52536-510-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (52536-510-03) ",
"NDC11Code": "52536-0510-03",
"ProductNDC": "52536-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090533",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210414",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) 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. .",
"Description": "Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49."
},
{
"NDCCode": "52536-125-10",
"PackageDescription": "10 BOTTLE in 1 CARTON (52536-125-10) / 50 mL in 1 BOTTLE (52536-125-01) ",
"NDC11Code": "52536-0125-10",
"ProductNDC": "52536-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212791",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250130",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).",
"Description": "Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is: Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine), 1 mg of L-Methionine and 9 mg sodium chloride in water for injection. The solution is preservative-free."
},
{
"NDCCode": "52536-126-08",
"PackageDescription": "8 BOTTLE in 1 CARTON (52536-126-08) / 100 mL in 1 BOTTLE (52536-126-01) ",
"NDC11Code": "52536-0126-08",
"ProductNDC": "52536-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212791",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250130",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).",
"Description": "Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is: Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine), 1 mg of L-Methionine and 9 mg sodium chloride in water for injection. The solution is preservative-free."
},
{
"NDCCode": "52536-129-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-129-01) ",
"NDC11Code": "52536-0129-01",
"ProductNDC": "52536-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205136",
"LabelerName": "Wilshire Pharmaceuticals Inc",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190415",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate."
},
{
"NDCCode": "52536-133-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-133-01) ",
"NDC11Code": "52536-0133-01",
"ProductNDC": "52536-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205136",
"LabelerName": "Wilshire Pharmaceuticals Inc",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190415",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate."
},
{
"NDCCode": "52536-137-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-137-01) ",
"NDC11Code": "52536-0137-01",
"ProductNDC": "52536-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205136",
"LabelerName": "Wilshire Pharmaceuticals Inc",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190415",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate."
},
{
"NDCCode": "52536-162-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (52536-162-01) ",
"NDC11Code": "52536-0162-01",
"ProductNDC": "52536-162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205973",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180206",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21H 26CIN 3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80. Its structural formula is."
},
{
"NDCCode": "52536-164-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (52536-164-01) ",
"NDC11Code": "52536-0164-01",
"ProductNDC": "52536-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205973",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180206",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21H 26CIN 3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80. Its structural formula is."
},
{
"NDCCode": "52536-168-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (52536-168-01) ",
"NDC11Code": "52536-0168-01",
"ProductNDC": "52536-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205973",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180206",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21H 26CIN 3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80. Its structural formula is."
},
{
"NDCCode": "52536-170-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (52536-170-01) ",
"NDC11Code": "52536-0170-01",
"ProductNDC": "52536-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205973",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180206",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21H 26CIN 3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80. Its structural formula is."
},
{
"NDCCode": "52536-175-01",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (52536-175-01) / 177.4 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "52536-0175-01",
"ProductNDC": "52536-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate",
"NonProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20260415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022372",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM",
"StrengthNumber": "17.5; 3.13; 1.6",
"StrengthUnit": "g/mL; g/mL; g/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260415",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older.",
"Description": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) is an osmotic laxative and is provided as two bottles each containing 4.5 ounces of solution. Each bottle contains: 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Potassium Sulfate, FCC, purified. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is:. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is:. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution also contains a polypropylene mixing container."
},
{
"NDCCode": "52536-177-01",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (52536-177-01) / 133.1 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "52536-0177-01",
"ProductNDC": "52536-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate",
"NonProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20260415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022372",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM",
"StrengthNumber": "13.13; 2.35; 1.2",
"StrengthUnit": "g/133.1mL; g/133.1mL; g/133.1mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260415",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older.",
"Description": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) is an osmotic laxative and is provided as two bottles each containing 4.5 ounces of solution. Each bottle contains: 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Potassium Sulfate, FCC, purified. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is:. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is:. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution also contains a polypropylene mixing container."
},
{
"NDCCode": "52536-236-01",
"PackageDescription": "4 L in 1 JUG (52536-236-01) ",
"NDC11Code": "52536-0236-01",
"ProductNDC": "52536-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Peg",
"ProprietaryNameSuffix": "3350 And Electrolytes",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019011",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090701",
"SamplePackage": "N",
"IndicationAndUsage": "PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.",
"Description": "PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "52536-302-01",
"PackageDescription": "4 L in 1 BOTTLE (52536-302-01) ",
"NDC11Code": "52536-0302-01",
"ProductNDC": "52536-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Peg",
"ProprietaryNameSuffix": "3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260415",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019797",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "420; 11.2; 5.72; 1.48",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260415",
"SamplePackage": "N",
"IndicationAndUsage": "PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.",
"Description": "For oral solution: Each 4 liter (4L) PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Each 4 liter jug contains: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.4 g, flavoring ingredients 2 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, USP. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "52536-401-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLE",
"NDC11Code": "52536-0401-01",
"ProductNDC": "52536-401",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240408",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208686",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240408",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate is an angiotensin-converting enzyme inhibitor indicated for: 1 treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1). , 2 treatment of symptomatic heart failure ( 1.2). , 3 treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure ( 1.3). .",
"Description": "Enalapril maleate oral solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C 20H 28N 2O 5C 4H 4O 4, and its structural formula is:. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril maleate oral solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include citric acid, mixed berry flavor, purified water, sodium benzoate, sodium citrate, and sucralose. It may also contain hydrochloric acid or sodium hydroxide for pH adjustment. Enalapril maleate oral solution is clear and colorless."
},
{
"NDCCode": "52536-500-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (52536-500-01) ",
"NDC11Code": "52536-0500-01",
"ProductNDC": "52536-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090533",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120716",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) 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. .",
"Description": "Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49."
},
{
"NDCCode": "52536-625-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52536-0625-01",
"ProductNDC": "52536-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206368",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190531",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with \"age-related hypogonadism\" (also referred to as \"late-onset hypogonadism\") have not been established.",
"Description": "Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP, is available as 200 mg/mL testosterone cypionate. Each mL of the 200 mg/mL solution contains:."
},
{
"NDCCode": "52536-880-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52536-880-01) ",
"NDC11Code": "52536-0880-01",
"ProductNDC": "52536-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19900529",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019614",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C 27H 38N 2O 4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide."
},
{
"NDCCode": "52536-882-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52536-882-01) ",
"NDC11Code": "52536-0882-01",
"ProductNDC": "52536-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19900529",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019614",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C 27H 38N 2O 4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide."
},
{
"NDCCode": "52536-884-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52536-884-01) ",
"NDC11Code": "52536-0884-01",
"ProductNDC": "52536-884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19900529",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019614",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C 27H 38N 2O 4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide."
},
{
"NDCCode": "52536-886-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52536-886-01) ",
"NDC11Code": "52536-0886-01",
"ProductNDC": "52536-886",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19900529",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019614",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C 27H 38N 2O 4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide."
},
{
"NDCCode": "10019-510-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (10019-510-01) > 5 mL in 1 VIAL, SINGLE-DOSE (10019-510-79)",
"NDC11Code": "10019-0510-01",
"ProductNDC": "10019-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078538",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-08-14"
},
{
"NDCCode": "10122-510-01",
"PackageDescription": "1.5 mL in 1 VIAL, GLASS (10122-510-01) ",
"NDC11Code": "10122-0510-01",
"ProductNDC": "10122-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Curosurf",
"NonProprietaryName": "Poractant Alfa",
"DosageFormName": "SUSPENSION",
"RouteName": "ENDOTRACHEAL",
"StartMarketingDate": "19991118",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020744",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "PORACTANT ALFA",
"StrengthNumber": "80",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alveolar Surface Tension Reduction [PE], Surfactant Activity [MoA], Surfactant [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991118",
"SamplePackage": "N",
"IndicationAndUsage": "CUROSURF® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.",
"Description": "Poractant alfa is an extract of natural porcine lung (pulmonary) surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight surfactant associated proteins (SP). The molecular weight of SP-B is 8.7 KDa and the molecular weight of SP-C is 3.7 KDa. CUROSURF (poractant alfa) intratracheal suspension is a sterile, white to creamy white suspension provided in a single-dose vial for intratracheal use. Each milliliter of suspension contains 80 mg of poractant alfa (surfactant extract) that includes 76 mg of phospholipids and 1 mg of SP of which 0.45 mg is SP-B, a 79-amino acid protein and 0.59 mg is SP-C, a 35-amino acid peptide . The amount of phospholipids is calculated from the content of phosphorus and contains 55 mg of phosphatidylcholine of which 30 mg is dipalmitoylphosphatidylcholine. It is suspended in 0.9% sodium chloride solution. The pH is adjusted with sodium bicarbonate to a pH of 6.2 (5.5 to 6.5). Curosurf contains no preservatives."
},
{
"NDCCode": "13537-510-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-510-02) > 4 g in 1 TUBE (13537-510-01)",
"NDC11Code": "13537-0510-02",
"ProductNDC": "13537-510",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Ultra Balm Moisturizing Protective Balm For Lips Spf 20",
"ProprietaryNameSuffix": "Cerise Brise - Pink",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161026",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".075; .049",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-510-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16714-510-01) ",
"NDC11Code": "16714-0510-01",
"ProductNDC": "16714-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170501",
"EndMarketingDate": "20240229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205085",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170501",
"EndMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol tablets is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use. Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [ see Dosage and Administration (2) ].",
"Description": "Carisoprodol tablets USP are available as 350 mg, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C 12 H 24 N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the Carisoprodol tablets USP drug product include lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, povidone, talc, and magnesium stearate."
},
{
"NDCCode": "24765-102-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (24765-102-02) / 510 mL in 1 CONTAINER (24765-102-01) ",
"NDC11Code": "24765-0102-02",
"ProductNDC": "24765-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr. Cellmo",
"NonProprietaryName": "Niacinamide",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160804",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Pharmacal-International. Co., Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": ".51",
"StrengthUnit": "mg/510mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160804",
"SamplePackage": "N"
},
{
"NDCCode": "30142-510-01",
"PackageDescription": "1 TUBE in 1 CARTON (30142-510-01) / 15 g in 1 TUBE",
"NDC11Code": "30142-0510-01",
"ProductNDC": "30142-510",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger",
"ProprietaryNameSuffix": "Jock Itch",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Kroger Company",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930831",
"SamplePackage": "N",
"IndicationAndUsage": "cures most jock itch. relieves itching, burning, scaling, chafing and discomfort associated with jock itch."
},
{
"NDCCode": "31722-510-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (31722-510-01) ",
"NDC11Code": "31722-0510-01",
"ProductNDC": "31722-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200895",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141209",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1a,3a,7b,8b( 2S*,4S*),-8ab]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white crystalline powder that is practically insoluble in water, freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol and very slightly soluble in hexane. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Additionally the 10 mg, 20 mg, 40 mg and 80 mg strengths contain: iron oxide red. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "42291-510-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01) ",
"NDC11Code": "42291-0510-01",
"ProductNDC": "42291-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primaquine Phosphate",
"NonProprietaryName": "Primaquine Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206043",
"LabelerName": "AvKARE",
"SubstanceName": "PRIMAQUINE PHOSPHATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190221",
"SamplePackage": "N",
"IndicationAndUsage": "Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.",
"Description": "Primaquine phosphate is 8-[(4-Amino-1-methylbutyl)-amino]-6- methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. Each tablet contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base. Inactive Ingredients: Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Triacetin, Pregelatinized Starch, FD&C Yellow#6/Sunset Yellow FCF Aluminum Lake, Talc, Titanium Dioxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52536-510-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-510-01) </PackageDescription>
<NDC11Code>52536-0510-01</NDC11Code>
<ProductNDC>52536-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090533</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) 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. .</IndicationAndUsage>
<Description>Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49.</Description>
</NDC>
<NDC>
<NDCCode>52536-510-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52536-510-03) </PackageDescription>
<NDC11Code>52536-0510-03</NDC11Code>
<ProductNDC>52536-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090533</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) 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. .</IndicationAndUsage>
<Description>Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49.</Description>
</NDC>
<NDC>
<NDCCode>52536-125-10</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (52536-125-10) / 50 mL in 1 BOTTLE (52536-125-01) </PackageDescription>
<NDC11Code>52536-0125-10</NDC11Code>
<ProductNDC>52536-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212791</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).</IndicationAndUsage>
<Description>Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is: Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine), 1 mg of L-Methionine and 9 mg sodium chloride in water for injection. The solution is preservative-free.</Description>
</NDC>
<NDC>
<NDCCode>52536-126-08</NDCCode>
<PackageDescription>8 BOTTLE in 1 CARTON (52536-126-08) / 100 mL in 1 BOTTLE (52536-126-01) </PackageDescription>
<NDC11Code>52536-0126-08</NDC11Code>
<ProductNDC>52536-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212791</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).</IndicationAndUsage>
<Description>Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is: Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine), 1 mg of L-Methionine and 9 mg sodium chloride in water for injection. The solution is preservative-free.</Description>
</NDC>
<NDC>
<NDCCode>52536-129-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-129-01) </PackageDescription>
<NDC11Code>52536-0129-01</NDC11Code>
<ProductNDC>52536-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205136</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals Inc</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>52536-133-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-133-01) </PackageDescription>
<NDC11Code>52536-0133-01</NDC11Code>
<ProductNDC>52536-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205136</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals Inc</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>52536-137-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-137-01) </PackageDescription>
<NDC11Code>52536-0137-01</NDC11Code>
<ProductNDC>52536-137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205136</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals Inc</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride tablets, a histamine (H1) receptor antagonist, are a white or slightly yellowish, crystalline powder. They have the following structural formula. Chemically, meclizine hydrochloride tablets are 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>52536-162-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (52536-162-01) </PackageDescription>
<NDC11Code>52536-0162-01</NDC11Code>
<ProductNDC>52536-162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205973</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21H 26CIN 3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>52536-164-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (52536-164-01) </PackageDescription>
<NDC11Code>52536-0164-01</NDC11Code>
<ProductNDC>52536-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205973</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21H 26CIN 3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>52536-168-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (52536-168-01) </PackageDescription>
<NDC11Code>52536-0168-01</NDC11Code>
<ProductNDC>52536-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205973</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21H 26CIN 3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>52536-170-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (52536-170-01) </PackageDescription>
<NDC11Code>52536-0170-01</NDC11Code>
<ProductNDC>52536-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205973</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21H 26CIN 3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>52536-175-01</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (52536-175-01) / 177.4 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>52536-0175-01</NDC11Code>
<ProductNDC>52536-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate</ProprietaryName>
<NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022372</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>17.5; 3.13; 1.6</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) is an osmotic laxative and is provided as two bottles each containing 4.5 ounces of solution. Each bottle contains: 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Potassium Sulfate, FCC, purified. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is:. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is:. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution also contains a polypropylene mixing container.</Description>
</NDC>
<NDC>
<NDCCode>52536-177-01</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (52536-177-01) / 133.1 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>52536-0177-01</NDC11Code>
<ProductNDC>52536-177</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate</ProprietaryName>
<NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022372</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>13.13; 2.35; 1.2</StrengthNumber>
<StrengthUnit>g/133.1mL; g/133.1mL; g/133.1mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) is an osmotic laxative and is provided as two bottles each containing 4.5 ounces of solution. Each bottle contains: 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Potassium Sulfate, FCC, purified. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is:. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is:. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution also contains a polypropylene mixing container.</Description>
</NDC>
<NDC>
<NDCCode>52536-236-01</NDCCode>
<PackageDescription>4 L in 1 JUG (52536-236-01) </PackageDescription>
<NDC11Code>52536-0236-01</NDC11Code>
<ProductNDC>52536-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Peg</ProprietaryName>
<ProprietaryNameSuffix>3350 And Electrolytes</ProprietaryNameSuffix>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019011</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.</IndicationAndUsage>
<Description>PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>52536-302-01</NDCCode>
<PackageDescription>4 L in 1 BOTTLE (52536-302-01) </PackageDescription>
<NDC11Code>52536-0302-01</NDC11Code>
<ProductNDC>52536-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Peg</ProprietaryName>
<ProprietaryNameSuffix>3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</ProprietaryNameSuffix>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260415</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019797</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>420; 11.2; 5.72; 1.48</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.</IndicationAndUsage>
<Description>For oral solution: Each 4 liter (4L) PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Each 4 liter jug contains: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.4 g, flavoring ingredients 2 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, USP. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>52536-401-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>52536-0401-01</NDC11Code>
<ProductNDC>52536-401</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240408</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208686</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate is an angiotensin-converting enzyme inhibitor indicated for: 1 treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1). , 2 treatment of symptomatic heart failure ( 1.2). , 3 treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure ( 1.3). .</IndicationAndUsage>
<Description>Enalapril maleate oral solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C 20H 28N 2O 5C 4H 4O 4, and its structural formula is:. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril maleate oral solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include citric acid, mixed berry flavor, purified water, sodium benzoate, sodium citrate, and sucralose. It may also contain hydrochloric acid or sodium hydroxide for pH adjustment. Enalapril maleate oral solution is clear and colorless.</Description>
</NDC>
<NDC>
<NDCCode>52536-500-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52536-500-01) </PackageDescription>
<NDC11Code>52536-0500-01</NDC11Code>
<ProductNDC>52536-500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090533</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) 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. .</IndicationAndUsage>
<Description>Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49.</Description>
</NDC>
<NDC>
<NDCCode>52536-625-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>52536-0625-01</NDC11Code>
<ProductNDC>52536-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206368</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP, is available as 200 mg/mL testosterone cypionate. Each mL of the 200 mg/mL solution contains:.</Description>
</NDC>
<NDC>
<NDCCode>52536-880-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52536-880-01) </PackageDescription>
<NDC11Code>52536-0880-01</NDC11Code>
<ProductNDC>52536-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900529</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019614</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C 27H 38N 2O 4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>52536-882-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52536-882-01) </PackageDescription>
<NDC11Code>52536-0882-01</NDC11Code>
<ProductNDC>52536-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900529</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019614</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C 27H 38N 2O 4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>52536-884-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52536-884-01) </PackageDescription>
<NDC11Code>52536-0884-01</NDC11Code>
<ProductNDC>52536-884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900529</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019614</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C 27H 38N 2O 4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>52536-886-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52536-886-01) </PackageDescription>
<NDC11Code>52536-0886-01</NDC11Code>
<ProductNDC>52536-886</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900529</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019614</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below. C 27H 38N 2O 4HCl M.W. 491.07. Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>10019-510-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (10019-510-01) > 5 mL in 1 VIAL, SINGLE-DOSE (10019-510-79)</PackageDescription>
<NDC11Code>10019-0510-01</NDC11Code>
<ProductNDC>10019-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078538</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>10122-510-01</NDCCode>
<PackageDescription>1.5 mL in 1 VIAL, GLASS (10122-510-01) </PackageDescription>
<NDC11Code>10122-0510-01</NDC11Code>
<ProductNDC>10122-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Curosurf</ProprietaryName>
<NonProprietaryName>Poractant Alfa</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ENDOTRACHEAL</RouteName>
<StartMarketingDate>19991118</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020744</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>PORACTANT ALFA</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alveolar Surface Tension Reduction [PE], Surfactant Activity [MoA], Surfactant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CUROSURF® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.</IndicationAndUsage>
<Description>Poractant alfa is an extract of natural porcine lung (pulmonary) surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight surfactant associated proteins (SP). The molecular weight of SP-B is 8.7 KDa and the molecular weight of SP-C is 3.7 KDa. CUROSURF (poractant alfa) intratracheal suspension is a sterile, white to creamy white suspension provided in a single-dose vial for intratracheal use. Each milliliter of suspension contains 80 mg of poractant alfa (surfactant extract) that includes 76 mg of phospholipids and 1 mg of SP of which 0.45 mg is SP-B, a 79-amino acid protein and 0.59 mg is SP-C, a 35-amino acid peptide . The amount of phospholipids is calculated from the content of phosphorus and contains 55 mg of phosphatidylcholine of which 30 mg is dipalmitoylphosphatidylcholine. It is suspended in 0.9% sodium chloride solution. The pH is adjusted with sodium bicarbonate to a pH of 6.2 (5.5 to 6.5). Curosurf contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>13537-510-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-510-02) > 4 g in 1 TUBE (13537-510-01)</PackageDescription>
<NDC11Code>13537-0510-02</NDC11Code>
<ProductNDC>13537-510</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Ultra Balm Moisturizing Protective Balm For Lips Spf 20</ProprietaryName>
<ProprietaryNameSuffix>Cerise Brise - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.075; .049</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-510-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16714-510-01) </PackageDescription>
<NDC11Code>16714-0510-01</NDC11Code>
<ProductNDC>16714-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170501</StartMarketingDate>
<EndMarketingDate>20240229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205085</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170501</StartMarketingDatePackage>
<EndMarketingDatePackage>20240229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol tablets is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use. Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [ see Dosage and Administration (2) ].</IndicationAndUsage>
<Description>Carisoprodol tablets USP are available as 350 mg, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C 12 H 24 N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the Carisoprodol tablets USP drug product include lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, povidone, talc, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>24765-102-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (24765-102-02) / 510 mL in 1 CONTAINER (24765-102-01) </PackageDescription>
<NDC11Code>24765-0102-02</NDC11Code>
<ProductNDC>24765-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr. Cellmo</ProprietaryName>
<NonProprietaryName>Niacinamide</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160804</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Pharmacal-International. Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>.51</StrengthNumber>
<StrengthUnit>mg/510mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-510-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (30142-510-01) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>30142-0510-01</NDC11Code>
<ProductNDC>30142-510</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger</ProprietaryName>
<ProprietaryNameSuffix>Jock Itch</ProprietaryNameSuffix>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most jock itch. relieves itching, burning, scaling, chafing and discomfort associated with jock itch.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-510-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (31722-510-01) </PackageDescription>
<NDC11Code>31722-0510-01</NDC11Code>
<ProductNDC>31722-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200895</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1a,3a,7b,8b( 2S*,4S*),-8ab]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white crystalline powder that is practically insoluble in water, freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol and very slightly soluble in hexane. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Additionally the 10 mg, 20 mg, 40 mg and 80 mg strengths contain: iron oxide red. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>42291-510-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01) </PackageDescription>
<NDC11Code>42291-0510-01</NDC11Code>
<ProductNDC>42291-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primaquine Phosphate</ProprietaryName>
<NonProprietaryName>Primaquine Phosphate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206043</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PRIMAQUINE PHOSPHATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.</IndicationAndUsage>
<Description>Primaquine phosphate is 8-[(4-Amino-1-methylbutyl)-amino]-6- methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. Each tablet contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base. Inactive Ingredients: Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Triacetin, Pregelatinized Starch, FD&C Yellow#6/Sunset Yellow FCF Aluminum Lake, Talc, Titanium Dioxide.</Description>
</NDC>
</NDCList>