{
"NDC": [
{
"NDCCode": "53808-0245-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0245-1)",
"NDC11Code": "53808-0245-01",
"ProductNDC": "53808-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epivir",
"NonProprietaryName": "Lamivudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020564",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "LAMIVUDINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.",
"Description": "EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C. EPIVIR Tablets are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. EPIVIR Oral Solution is for oral administration. One milliliter (1 mL) of EPIVIR Oral Solution contains 10 mg of lamivudine (10 mg/mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg)."
},
{
"NDCCode": "0004-0245-15",
"PackageDescription": "270 CAPSULE in 1 BOTTLE, PLASTIC (0004-0245-15) ",
"NDC11Code": "00004-0245-15",
"ProductNDC": "0004-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invirase",
"NonProprietaryName": "Saquinavir Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19951206",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020628",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "SAQUINAVIR MESYLATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19951206",
"SamplePackage": "N"
},
{
"NDCCode": "0037-0245-06",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (0037-0245-06) > 28 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "00037-0245-06",
"ProductNDC": "0037-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dymista",
"NonProprietaryName": "Azelastine Hydrochloride And Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202236",
"LabelerName": "Meda Pharmaceuticals",
"SubstanceName": "AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE",
"StrengthNumber": "137; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N"
},
{
"NDCCode": "0037-0245-23",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "00037-0245-23",
"ProductNDC": "0037-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dymista",
"NonProprietaryName": "Azelastine Hydrochloride And Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20161001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202236",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE",
"StrengthNumber": "137; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161001",
"SamplePackage": "N",
"IndicationAndUsage": "DYMISTA is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.",
"Description": "DYMISTA (azelastine hydrochloride and fluticasone propionate) nasal spray is formulated as a white, uniform metered-spray suspension for nasal administration. It is a fixed dose combination product containing an antihistamine (H1 receptor antagonist) and a corticosteroid as active ingredients. Azelastine hydrochloride active ingredient occurs as a white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerin. It has a melting point of 225°C and the pH of 5.2. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3OHCl with the following chemical structure. Fluticasone propionate active ingredient is a white powder with a melting point of 273°C, a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Fluticasone propionate is a synthetic corticosteroid having the chemical name S-(fluoromethyl)-6α,9α-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate, and the following chemical structure. DYMISTA (azelastine hydrochloride and fluticasone propionate) nasal spray, 137 mcg/50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension containing benzalkonium chloride (0.1 mg/g), carboxymethylcellulose sodium, edetate disodium, glycerin, microcrystalline cellulose, phenylethyl alcohol (2.5 mg/g), polysorbate 80, and purified water. It has a pH of approximately 6.0. After priming [see Dosage and Administration (2.2)], each metered spray delivers a 0.137 mL mean volume of suspension containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base) and 50 mcg of fluticasone propionate. The 23 g bottle provides 120 metered sprays, after priming."
},
{
"NDCCode": "0054-0245-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0245-25) ",
"NDC11Code": "00054-0245-25",
"ProductNDC": "0054-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Codeine Sulfate",
"NonProprietaryName": "Codeine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090716",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022402",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "CODEINE SULFATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090716",
"SamplePackage": "N",
"IndicationAndUsage": "Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Codeine Sulfate Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .",
"Description": "Codeine Sulfate Tablets, USP contain codeine, an opioid agonist, available for oral administration containing either 15 mg, 30 mg, or 60 mg of codeine sulfate, USP. The chemical name is morphinan-6-ol,7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-(5α,6α)-, sulfate (2:1) (salt), trihydrate. Its molecular formula is (C18H21NO3)2 H2SO4 3H2O and its molecular weight is 750.85 g/mol. Its structure is as follows. Codeine sulfate trihydrate is a fine, white, crystalline powder which is soluble in water and insoluble in chloroform and ether. The inactive ingredients in Codeine Sulfate Tablets, USP include: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid."
},
{
"NDCCode": "0135-0245-02",
"PackageDescription": "60 TABLET, CHEWABLE in 1 BOTTLE (0135-0245-02) ",
"NDC11Code": "00135-0245-02",
"ProductNDC": "0135-0245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tums",
"ProprietaryNameSuffix": "Smoothies",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20100324",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100324",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "0135-0245-03",
"PackageDescription": "72 TABLET, CHEWABLE in 1 BOTTLE (0135-0245-03)",
"NDC11Code": "00135-0245-03",
"ProductNDC": "0135-0245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tums",
"ProprietaryNameSuffix": "Smoothies",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20100324",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "GlaxoSmithKline Consumer Heathcare LP",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-08-15"
},
{
"NDCCode": "0179-0245-70",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOX, UNIT-DOSE (0179-0245-70) ",
"NDC11Code": "00179-0245-70",
"ProductNDC": "0179-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20180726",
"EndMarketingDate": "20190331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075765",
"LabelerName": "KAISER FOUNDATION HOSPITALS",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS],Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180726",
"EndMarketingDatePackage": "20190331",
"SamplePackage": "N"
},
{
"NDCCode": "0187-0245-01",
"PackageDescription": "1 VIAL in 1 KIT (0187-0245-01) / 1 mL in 1 VIAL",
"NDC11Code": "00187-0245-01",
"ProductNDC": "0187-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Migranal",
"NonProprietaryName": "Dihydroergotamine Mesylate",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19971208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020148",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971208",
"SamplePackage": "Y",
"IndicationAndUsage": "MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
"Description": "MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33H 37N 5O 5CH 4O 3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous .……..10 mg, 3 dextrose, anhydrous ……...50 mg, 4 carbon dioxide ………….qs, 5 purified water .. ……..qs 1 mL."
},
{
"NDCCode": "0187-0245-03",
"PackageDescription": "8 VIAL in 1 KIT (0187-0245-03) > 1 mL in 1 VIAL",
"NDC11Code": "00187-0245-03",
"ProductNDC": "0187-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Migranal",
"NonProprietaryName": "Dihydroergotamine Mesylate",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19971208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020148",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19971208",
"SamplePackage": "N",
"IndicationAndUsage": "MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
"Description": "MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5CH4O3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous ……..10 mg, 3 dextrose, anhydrous ……..50 mg, 4 carbon dioxide ………….qs, 5 purified water.. ……..qs 1 mL."
},
{
"NDCCode": "0187-0245-04",
"PackageDescription": "1 VIAL in 1 KIT (0187-0245-04) / 1 mL in 1 VIAL",
"NDC11Code": "00187-0245-04",
"ProductNDC": "0187-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Migranal",
"NonProprietaryName": "Dihydroergotamine Mesylate",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19971208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020148",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971208",
"SamplePackage": "N",
"IndicationAndUsage": "MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
"Description": "MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33H 37N 5O 5CH 4O 3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous .……..10 mg, 3 dextrose, anhydrous ……...50 mg, 4 carbon dioxide ………….qs, 5 purified water .. ……..qs 1 mL."
},
{
"NDCCode": "0245-0003-08",
"PackageDescription": "237 mL in 1 BOTTLE (0245-0003-08)",
"NDC11Code": "00245-0003-08",
"ProductNDC": "0245-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sski",
"NonProprietaryName": "Potassium Iodide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19730430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "POTASSIUM IODIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0245-0003-31",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (0245-0003-31) > 30 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "00245-0003-31",
"ProductNDC": "0245-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sski",
"NonProprietaryName": "Potassium Iodide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19730430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "POTASSIUM IODIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-12",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0245-0008-35",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (0245-0008-35) > 3.7 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "00245-0008-35",
"ProductNDC": "0245-0008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fortical",
"NonProprietaryName": "Calcitonin Salmon",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021406",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "CALCITONIN SALMON",
"StrengthNumber": "2200",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Calcitonin [CS],Calcitonin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0245-0012-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0245-0012-01) / 1 TABLET in 1 BLISTER PACK (0245-0012-89) ",
"NDC11Code": "00245-0012-01",
"ProductNDC": "0245-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110215",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0012-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (0245-0012-11) ",
"NDC11Code": "00245-0012-11",
"ProductNDC": "0245-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0013-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0245-0013-01) / 1 TABLET in 1 BLISTER PACK (0245-0013-89) ",
"NDC11Code": "00245-0013-01",
"ProductNDC": "0245-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
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"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0013-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (0245-0013-11) ",
"NDC11Code": "00245-0013-11",
"ProductNDC": "0245-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20110215",
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"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0014-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0245-0014-01) / 1 TABLET in 1 BLISTER PACK (0245-0014-89) ",
"NDC11Code": "00245-0014-01",
"ProductNDC": "0245-0014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0014-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (0245-0014-11) ",
"NDC11Code": "00245-0014-11",
"ProductNDC": "0245-0014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110215",
"SamplePackage": "N",
"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0015-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0245-0015-01) > 1 TABLET in 1 BLISTER PACK (0245-0015-89) ",
"NDC11Code": "00245-0015-01",
"ProductNDC": "0245-0015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110215",
"SamplePackage": "N",
"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0015-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (0245-0015-11) ",
"NDC11Code": "00245-0015-11",
"ProductNDC": "0245-0015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110215",
"SamplePackage": "N",
"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0035-01",
"PackageDescription": "100 PACKET in 1 CARTON (0245-0035-01) > 1 POWDER, FOR SOLUTION in 1 PACKET (0245-0035-89)",
"NDC11Code": "00245-0035-01",
"ProductNDC": "0245-0035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klor-con",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "0245-0035-30",
"PackageDescription": "30 PACKET in 1 CARTON (0245-0035-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (0245-0035-89)",
"NDC11Code": "00245-0035-30",
"ProductNDC": "0245-0035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klor-con",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "0245-0036-23",
"PackageDescription": "231 g in 1 CAN (0245-0036-23) ",
"NDC11Code": "00245-0036-23",
"ProductNDC": "0245-0036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevalite",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19960201",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073263",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/5.5g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960201",
"EndMarketingDatePackage": "20271031",
"SamplePackage": "N",
"IndicationAndUsage": "1) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ®(cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total Cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.",
"Description": "Prevalite ®(cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ®(cholestyramine for oral suspension, USP) is not absorbed from the digestive tract. 5.5 grams of Prevalite ®(cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula:. Prevalite ®(cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor."
},
{
"NDCCode": "0245-0036-42",
"PackageDescription": "42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89) ",
"NDC11Code": "00245-0036-42",
"ProductNDC": "0245-0036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevalite",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19960201",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073263",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/5.5g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960201",
"EndMarketingDatePackage": "20271031",
"SamplePackage": "N",
"IndicationAndUsage": "1) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ®(cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total Cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.",
"Description": "Prevalite ®(cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ®(cholestyramine for oral suspension, USP) is not absorbed from the digestive tract. 5.5 grams of Prevalite ®(cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula:. Prevalite ®(cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor."
},
{
"NDCCode": "0245-0036-60",
"PackageDescription": "60 PACKET in 1 CARTON (0245-0036-60) / 5.5 g in 1 PACKET (0245-0036-89) ",
"NDC11Code": "00245-0036-60",
"ProductNDC": "0245-0036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevalite",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19960201",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073263",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/5.5g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960201",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "1) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ®(cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total Cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.",
"Description": "Prevalite ®(cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ®(cholestyramine for oral suspension, USP) is not absorbed from the digestive tract. 5.5 grams of Prevalite ®(cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula:. Prevalite ®(cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor."
},
{
"NDCCode": "0245-0037-01",
"PackageDescription": "100 PACKET in 1 CARTON (0245-0037-01) > 1 POWDER, FOR SOLUTION in 1 PACKET (0245-0037-89)",
"NDC11Code": "00245-0037-01",
"ProductNDC": "0245-0037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klor-con",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.875",
"StrengthUnit": "g/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "0245-0037-30",
"PackageDescription": "30 PACKET in 1 CARTON (0245-0037-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (0245-0037-89)",
"NDC11Code": "00245-0037-30",
"ProductNDC": "0245-0037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klor-con",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.875",
"StrengthUnit": "g/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "0245-0039-01",
"PackageDescription": "100 TABLET, EFFERVESCENT in 1 CARTON (0245-0039-01) ",
"NDC11Code": "00245-0039-01",
"ProductNDC": "0245-0039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Bicarbonate",
"NonProprietaryName": "Potassium Bicarbonate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20140901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "POTASSIUM BICARBONATE",
"StrengthNumber": "978",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140901",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>53808-0245-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0245-1)</PackageDescription>
<NDC11Code>53808-0245-01</NDC11Code>
<ProductNDC>53808-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epivir</ProprietaryName>
<NonProprietaryName>Lamivudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020564</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>LAMIVUDINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.</IndicationAndUsage>
<Description>EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C. EPIVIR Tablets are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. EPIVIR Oral Solution is for oral administration. One milliliter (1 mL) of EPIVIR Oral Solution contains 10 mg of lamivudine (10 mg/mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).</Description>
</NDC>
<NDC>
<NDCCode>0004-0245-15</NDCCode>
<PackageDescription>270 CAPSULE in 1 BOTTLE, PLASTIC (0004-0245-15) </PackageDescription>
<NDC11Code>00004-0245-15</NDC11Code>
<ProductNDC>0004-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invirase</ProprietaryName>
<NonProprietaryName>Saquinavir Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951206</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020628</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>SAQUINAVIR MESYLATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0037-0245-06</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (0037-0245-06) > 28 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>00037-0245-06</NDC11Code>
<ProductNDC>0037-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dymista</ProprietaryName>
<NonProprietaryName>Azelastine Hydrochloride And Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202236</ApplicationNumber>
<LabelerName>Meda Pharmaceuticals</LabelerName>
<SubstanceName>AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>137; 50</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0037-0245-23</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>00037-0245-23</NDC11Code>
<ProductNDC>0037-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dymista</ProprietaryName>
<NonProprietaryName>Azelastine Hydrochloride And Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20161001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202236</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>137; 50</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DYMISTA is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.</IndicationAndUsage>
<Description>DYMISTA (azelastine hydrochloride and fluticasone propionate) nasal spray is formulated as a white, uniform metered-spray suspension for nasal administration. It is a fixed dose combination product containing an antihistamine (H1 receptor antagonist) and a corticosteroid as active ingredients. Azelastine hydrochloride active ingredient occurs as a white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerin. It has a melting point of 225°C and the pH of 5.2. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3OHCl with the following chemical structure. Fluticasone propionate active ingredient is a white powder with a melting point of 273°C, a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Fluticasone propionate is a synthetic corticosteroid having the chemical name S-(fluoromethyl)-6α,9α-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate, and the following chemical structure. DYMISTA (azelastine hydrochloride and fluticasone propionate) nasal spray, 137 mcg/50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension containing benzalkonium chloride (0.1 mg/g), carboxymethylcellulose sodium, edetate disodium, glycerin, microcrystalline cellulose, phenylethyl alcohol (2.5 mg/g), polysorbate 80, and purified water. It has a pH of approximately 6.0. After priming [see Dosage and Administration (2.2)], each metered spray delivers a 0.137 mL mean volume of suspension containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base) and 50 mcg of fluticasone propionate. The 23 g bottle provides 120 metered sprays, after priming.</Description>
</NDC>
<NDC>
<NDCCode>0054-0245-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0245-25) </PackageDescription>
<NDC11Code>00054-0245-25</NDC11Code>
<ProductNDC>0054-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Codeine Sulfate</ProprietaryName>
<NonProprietaryName>Codeine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090716</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022402</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CODEINE SULFATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Codeine Sulfate Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .</IndicationAndUsage>
<Description>Codeine Sulfate Tablets, USP contain codeine, an opioid agonist, available for oral administration containing either 15 mg, 30 mg, or 60 mg of codeine sulfate, USP. The chemical name is morphinan-6-ol,7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-(5α,6α)-, sulfate (2:1) (salt), trihydrate. Its molecular formula is (C18H21NO3)2 H2SO4 3H2O and its molecular weight is 750.85 g/mol. Its structure is as follows. Codeine sulfate trihydrate is a fine, white, crystalline powder which is soluble in water and insoluble in chloroform and ether. The inactive ingredients in Codeine Sulfate Tablets, USP include: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0135-0245-02</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOTTLE (0135-0245-02) </PackageDescription>
<NDC11Code>00135-0245-02</NDC11Code>
<ProductNDC>0135-0245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tums</ProprietaryName>
<ProprietaryNameSuffix>Smoothies</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0245-03</NDCCode>
<PackageDescription>72 TABLET, CHEWABLE in 1 BOTTLE (0135-0245-03)</PackageDescription>
<NDC11Code>00135-0245-03</NDC11Code>
<ProductNDC>0135-0245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tums</ProprietaryName>
<ProprietaryNameSuffix>Smoothies</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Heathcare LP</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0179-0245-70</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOX, UNIT-DOSE (0179-0245-70) </PackageDescription>
<NDC11Code>00179-0245-70</NDC11Code>
<ProductNDC>0179-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180726</StartMarketingDate>
<EndMarketingDate>20190331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075765</ApplicationNumber>
<LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS],Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180726</StartMarketingDatePackage>
<EndMarketingDatePackage>20190331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0187-0245-01</NDCCode>
<PackageDescription>1 VIAL in 1 KIT (0187-0245-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00187-0245-01</NDC11Code>
<ProductNDC>0187-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Migranal</ProprietaryName>
<NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19971208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020148</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>DIHYDROERGOTAMINE MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971208</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.</IndicationAndUsage>
<Description>MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33H 37N 5O 5CH 4O 3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous .……..10 mg, 3 dextrose, anhydrous ……...50 mg, 4 carbon dioxide ………….qs, 5 purified water .. ……..qs 1 mL.</Description>
</NDC>
<NDC>
<NDCCode>0187-0245-03</NDCCode>
<PackageDescription>8 VIAL in 1 KIT (0187-0245-03) > 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00187-0245-03</NDC11Code>
<ProductNDC>0187-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Migranal</ProprietaryName>
<NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19971208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020148</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>DIHYDROERGOTAMINE MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.</IndicationAndUsage>
<Description>MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5CH4O3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous ……..10 mg, 3 dextrose, anhydrous ……..50 mg, 4 carbon dioxide ………….qs, 5 purified water.. ……..qs 1 mL.</Description>
</NDC>
<NDC>
<NDCCode>0187-0245-04</NDCCode>
<PackageDescription>1 VIAL in 1 KIT (0187-0245-04) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00187-0245-04</NDC11Code>
<ProductNDC>0187-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Migranal</ProprietaryName>
<NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19971208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020148</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>DIHYDROERGOTAMINE MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.</IndicationAndUsage>
<Description>MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33H 37N 5O 5CH 4O 3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous .……..10 mg, 3 dextrose, anhydrous ……...50 mg, 4 carbon dioxide ………….qs, 5 purified water .. ……..qs 1 mL.</Description>
</NDC>
<NDC>
<NDCCode>0245-0003-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (0245-0003-08)</PackageDescription>
<NDC11Code>00245-0003-08</NDC11Code>
<ProductNDC>0245-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sski</ProprietaryName>
<NonProprietaryName>Potassium Iodide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19730430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0245-0003-31</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (0245-0003-31) > 30 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>00245-0003-31</NDC11Code>
<ProductNDC>0245-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sski</ProprietaryName>
<NonProprietaryName>Potassium Iodide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19730430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-12</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0245-0008-35</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (0245-0008-35) > 3.7 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>00245-0008-35</NDC11Code>
<ProductNDC>0245-0008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fortical</ProprietaryName>
<NonProprietaryName>Calcitonin Salmon</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021406</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>CALCITONIN SALMON</SubstanceName>
<StrengthNumber>2200</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Calcitonin [CS],Calcitonin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0245-0012-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0245-0012-01) / 1 TABLET in 1 BLISTER PACK (0245-0012-89) </PackageDescription>
<NDC11Code>00245-0012-01</NDC11Code>
<ProductNDC>0245-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0012-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0245-0012-11) </PackageDescription>
<NDC11Code>00245-0012-11</NDC11Code>
<ProductNDC>0245-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0013-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0245-0013-01) / 1 TABLET in 1 BLISTER PACK (0245-0013-89) </PackageDescription>
<NDC11Code>00245-0013-01</NDC11Code>
<ProductNDC>0245-0013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0013-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0245-0013-11) </PackageDescription>
<NDC11Code>00245-0013-11</NDC11Code>
<ProductNDC>0245-0013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0014-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0245-0014-01) / 1 TABLET in 1 BLISTER PACK (0245-0014-89) </PackageDescription>
<NDC11Code>00245-0014-01</NDC11Code>
<ProductNDC>0245-0014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0014-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0245-0014-11) </PackageDescription>
<NDC11Code>00245-0014-11</NDC11Code>
<ProductNDC>0245-0014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0015-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0245-0015-01) > 1 TABLET in 1 BLISTER PACK (0245-0015-89) </PackageDescription>
<NDC11Code>00245-0015-01</NDC11Code>
<ProductNDC>0245-0015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0015-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0245-0015-11) </PackageDescription>
<NDC11Code>00245-0015-11</NDC11Code>
<ProductNDC>0245-0015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0035-01</NDCCode>
<PackageDescription>100 PACKET in 1 CARTON (0245-0035-01) > 1 POWDER, FOR SOLUTION in 1 PACKET (0245-0035-89)</PackageDescription>
<NDC11Code>00245-0035-01</NDC11Code>
<ProductNDC>0245-0035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klor-con</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0245-0035-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (0245-0035-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (0245-0035-89)</PackageDescription>
<NDC11Code>00245-0035-30</NDC11Code>
<ProductNDC>0245-0035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klor-con</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0245-0036-23</NDCCode>
<PackageDescription>231 g in 1 CAN (0245-0036-23) </PackageDescription>
<NDC11Code>00245-0036-23</NDC11Code>
<ProductNDC>0245-0036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevalite</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960201</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073263</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/5.5g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960201</StartMarketingDatePackage>
<EndMarketingDatePackage>20271031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ®(cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total Cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.</IndicationAndUsage>
<Description>Prevalite ®(cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ®(cholestyramine for oral suspension, USP) is not absorbed from the digestive tract. 5.5 grams of Prevalite ®(cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula:. Prevalite ®(cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor.</Description>
</NDC>
<NDC>
<NDCCode>0245-0036-42</NDCCode>
<PackageDescription>42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89) </PackageDescription>
<NDC11Code>00245-0036-42</NDC11Code>
<ProductNDC>0245-0036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevalite</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960201</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073263</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/5.5g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960201</StartMarketingDatePackage>
<EndMarketingDatePackage>20271031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ®(cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total Cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.</IndicationAndUsage>
<Description>Prevalite ®(cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ®(cholestyramine for oral suspension, USP) is not absorbed from the digestive tract. 5.5 grams of Prevalite ®(cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula:. Prevalite ®(cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor.</Description>
</NDC>
<NDC>
<NDCCode>0245-0036-60</NDCCode>
<PackageDescription>60 PACKET in 1 CARTON (0245-0036-60) / 5.5 g in 1 PACKET (0245-0036-89) </PackageDescription>
<NDC11Code>00245-0036-60</NDC11Code>
<ProductNDC>0245-0036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevalite</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960201</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073263</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/5.5g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960201</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ®(cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total Cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.</IndicationAndUsage>
<Description>Prevalite ®(cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ®(cholestyramine for oral suspension, USP) is not absorbed from the digestive tract. 5.5 grams of Prevalite ®(cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula:. Prevalite ®(cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor.</Description>
</NDC>
<NDC>
<NDCCode>0245-0037-01</NDCCode>
<PackageDescription>100 PACKET in 1 CARTON (0245-0037-01) > 1 POWDER, FOR SOLUTION in 1 PACKET (0245-0037-89)</PackageDescription>
<NDC11Code>00245-0037-01</NDC11Code>
<ProductNDC>0245-0037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klor-con</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.875</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0245-0037-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (0245-0037-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (0245-0037-89)</PackageDescription>
<NDC11Code>00245-0037-30</NDC11Code>
<ProductNDC>0245-0037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klor-con</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.875</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0245-0039-01</NDCCode>
<PackageDescription>100 TABLET, EFFERVESCENT in 1 CARTON (0245-0039-01) </PackageDescription>
<NDC11Code>00245-0039-01</NDC11Code>
<ProductNDC>0245-0039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Bicarbonate</ProprietaryName>
<NonProprietaryName>Potassium Bicarbonate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>POTASSIUM BICARBONATE</SubstanceName>
<StrengthNumber>978</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>