{
"NDC": [
{
"NDCCode": "73096-766-40",
"PackageDescription": "40 g in 1 CYLINDER (73096-766-40) ",
"NDC11Code": "73096-0766-40",
"ProductNDC": "73096-766",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbd Clinic Pain Relief - Level 5",
"NonProprietaryName": "Menthol, Camphor",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "MENTHOL; CAMPHOR (NATURAL)",
"StrengthNumber": "16; 11",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains."
},
{
"NDCCode": "24909-766-40",
"PackageDescription": "40 g in 1 CYLINDER (24909-766-40) ",
"NDC11Code": "24909-0766-40",
"ProductNDC": "24909-766",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbd Clinic Pain Relief - Level 5",
"NonProprietaryName": "Menthol, Camphor",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "CAMPHOR (NATURAL); MENTHOL",
"StrengthNumber": "11; 16",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains."
},
{
"NDCCode": "49349-766-50",
"PackageDescription": "40 TABLET in 1 BOTTLE (49349-766-50)",
"NDC11Code": "49349-0766-50",
"ProductNDC": "49349-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parafon Forte Dsc",
"NonProprietaryName": "Chlorzoxazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011529",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CHLORZOXAZONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "59726-766-40",
"PackageDescription": "400 TABLET in 1 BOTTLE, PLASTIC (59726-766-40) ",
"NDC11Code": "59726-0766-40",
"ProductNDC": "59726-766",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"EndMarketingDate": "20241129",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part336",
"LabelerName": "P & L Development, LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191129",
"EndMarketingDatePackage": "20241129",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nose sneezing ."
},
{
"NDCCode": "63285-766-02",
"PackageDescription": "40 BOTTLE, PLASTIC in 1 CASE (63285-766-02) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63285-766-01)",
"NDC11Code": "63285-0766-02",
"ProductNDC": "63285-766",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ponatinib Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20121214",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Inc.",
"SubstanceName": "PONATINIB HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "73096-742-40",
"PackageDescription": "1 TUBE in 1 CARTON (73096-742-40) > 40 g in 1 TUBE",
"NDC11Code": "73096-0742-40",
"ProductNDC": "73096-742",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbdmedic Active Sport Pain Relief",
"NonProprietaryName": "Camphor And Menthol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "CAMPHOR (NATURAL); MENTHOL",
"StrengthNumber": "100; 150",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of minor aches and pains of muscles and joints associated with strains, bruises and sprains."
},
{
"NDCCode": "73096-743-40",
"PackageDescription": "1 TUBE in 1 CARTON (73096-743-40) / 40 g in 1 TUBE",
"NDC11Code": "73096-0743-40",
"ProductNDC": "73096-743",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbdmedic Arthritis Aches And Pain Relief",
"NonProprietaryName": "Camphor And Menthol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "CAMPHOR (NATURAL); MENTHOL",
"StrengthNumber": "100; 100",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of minor aches and pains of muscles and joints associated with arthritis."
},
{
"NDCCode": "73096-745-40",
"PackageDescription": "1 TUBE in 1 CARTON (73096-745-40) / 40 g in 1 TUBE",
"NDC11Code": "73096-0745-40",
"ProductNDC": "73096-745",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbdmedic Back And Neck Pain Relief",
"NonProprietaryName": "Camphor And Menthol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "CAMPHOR (NATURAL); MENTHOL",
"StrengthNumber": "100; 150",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of minor aches and pains of muscles and joints associated with simple backache, neck and shoulder strains."
},
{
"NDCCode": "73096-746-40",
"PackageDescription": "1 TUBE in 1 CARTON (73096-746-40) > 40 g in 1 TUBE",
"NDC11Code": "73096-0746-40",
"ProductNDC": "73096-746",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbdmedic Foot And Ankle Pain Relief",
"NonProprietaryName": "Camphor And Menthol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "CAMPHOR (NATURAL); MENTHOL",
"StrengthNumber": "100; 150",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of minor aches and pains of muscles and joints associated with feet, toes and ankles."
},
{
"NDCCode": "73096-751-40",
"PackageDescription": "1 TUBE in 1 CARTON (73096-751-40) > 40 g in 1 TUBE",
"NDC11Code": "73096-0751-40",
"ProductNDC": "73096-751",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbdmedic Eczema Therapy",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "OATMEAL",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritations and itching due to eczema rashes."
},
{
"NDCCode": "73096-767-40",
"PackageDescription": "1 TUBE in 1 CARTON (73096-767-40) > 40 g in 1 TUBE",
"NDC11Code": "73096-0767-40",
"ProductNDC": "73096-767",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbdmedic Acne Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": " For the management of acne Clears up most acne blemishes, acne pimples, blackheads, and whiteheads and allows the skin to heal."
},
{
"NDCCode": "73096-744-48",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (73096-744-48) > 48 g in 1 BOTTLE, PUMP",
"NDC11Code": "73096-0744-48",
"ProductNDC": "73096-744",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbdmedic Arthritis Aches And Pain Relief",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of minor aches and pains of muscles and joints associated with arthritis."
},
{
"NDCCode": "73096-750-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (73096-750-04) > 103 mL in 1 BOTTLE",
"NDC11Code": "73096-0750-04",
"ProductNDC": "73096-750",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbdmedic Massage Therapy Pain Relief",
"NonProprietaryName": "Camphor And Menthol",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "ABACUS HEALTH PRODUCTS, INC.",
"SubstanceName": "CAMPHOR (NATURAL); MENTHOL",
"StrengthNumber": "31; 40",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "10135-766-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-766-01) ",
"NDC11Code": "10135-0766-01",
"ProductNDC": "10135-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metolazone",
"NonProprietaryName": "Metolazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216216",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "METOLAZONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure;, 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.",
"Description": "Metolazone tablets, USP, for oral administration contain 2.5, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4- tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and dye: 2.5 mg - FD&C Red No. 40 and FD&C Blue No. 2; 5 mg - FD&C Blue No. 2; 10 mg - D&C Yellow No. 10."
},
{
"NDCCode": "10135-766-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10135-766-10) ",
"NDC11Code": "10135-0766-10",
"ProductNDC": "10135-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metolazone",
"NonProprietaryName": "Metolazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216216",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "METOLAZONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure;, 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.",
"Description": "Metolazone tablets, USP, for oral administration contain 2.5, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4- tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and dye: 2.5 mg - FD&C Red No. 40 and FD&C Blue No. 2; 5 mg - FD&C Blue No. 2; 10 mg - D&C Yellow No. 10."
},
{
"NDCCode": "21695-808-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (21695-808-30)",
"NDC11Code": "21695-0808-30",
"ProductNDC": "21695-808",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075579",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate USP is chemically described as (±)-1-[4-[[2-(1-methylethoxy) ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide USP (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its molecular formula is C7H8CIN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP....................................................................................................2.5 mg. Hydrochlorothiazide USP ................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP........................................................................................................5 mg. Hydrochlorothiazide USP..................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP.....................................................................................................10 mg. Hydrochlorothiazide USP.................................................................................................6.25 mg. Inactive ingredients include: colloidal silicon dioxide, corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Both the 2.5 mg/6.25 mg and the 5 mg/6.25 mg tablets contain FD&C yellow #6 aluminum lake. In addition, the 5 mg/6.25 mg tablets contain FD&C red #40 aluminium lake."
},
{
"NDCCode": "21695-809-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (21695-809-30)",
"NDC11Code": "21695-0809-30",
"ProductNDC": "21695-809",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075579",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate USP is chemically described as (±)-1-[4-[[2-(1-methylethoxy) ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide USP (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its molecular formula is C7H8CIN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP....................................................................................................2.5 mg. Hydrochlorothiazide USP ................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP........................................................................................................5 mg. Hydrochlorothiazide USP..................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP.....................................................................................................10 mg. Hydrochlorothiazide USP.................................................................................................6.25 mg. Inactive ingredients include: colloidal silicon dioxide, corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Both the 2.5 mg/6.25 mg and the 5 mg/6.25 mg tablets contain FD&C yellow #6 aluminum lake. In addition, the 5 mg/6.25 mg tablets contain FD&C red #40 aluminium lake."
},
{
"NDCCode": "23155-766-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (23155-766-01) ",
"NDC11Code": "23155-0766-01",
"ProductNDC": "23155-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062752",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible., 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis caused by Chlamydophila psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Klebsiella granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino) -1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. Inactive Ingredients: Lactose, and magnesium stearate. The 250 mg and 500 mg capsule shells contain D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink for the 250 mg and 500 mg capsules contains D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol, n-butyl alcohol, and ferrosoferric oxide. This product complies with USP dissolution Test 2."
},
{
"NDCCode": "50268-766-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-766-15) / 1 CAPSULE in 1 BLISTER PACK (50268-766-11) ",
"NDC11Code": "50268-0766-15",
"ProductNDC": "50268-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075317",
"LabelerName": "AvPAK",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200213",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name,molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride.C 19H 26ClN 5O 4. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Each capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochlolde. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains black iron oxide; the 2 mg capsule shell also contains D&C Yellow #10; the 5 mg capsule shell also contains D&C Yellow #10, FD&C Red #40 and D&C Red #28; the 10 mg capsule shell also contains FD&C Green #3 and D&C Yellow#10."
},
{
"NDCCode": "51079-766-08",
"PackageDescription": "80 BLISTER PACK in 1 CARTON (51079-766-08) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-766-01) ",
"NDC11Code": "51079-0766-08",
"ProductNDC": "51079-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077567",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090203",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium extended-release tablets are indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium, USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release 250 and 500 mg tablets are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 or 500 mg of valproic acid. Inactive Ingredients: ammonium hydroxide, colloidal anhydrous silica, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hydroxyethyl cellulose, hypromellose, oleic acid, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide and triacetin. Meets USP Dissolution Test 3. Each 250 mg divalproex sodium extended-release tablet contains 20 mg of sodium. Each 500 mg divalproex sodium extended-release tablet contains 40 mg of sodium."
},
{
"NDCCode": "51655-766-52",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-766-52) ",
"NDC11Code": "51655-0766-52",
"ProductNDC": "51655-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202389",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210727",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for the: 1 treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1) , 2 treatment of generalized anxiety disorder (GAD) in adults ( 1) .",
"Description": "Escitalopram oxalate contains escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol."
},
{
"NDCCode": "52817-268-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-268-30) ",
"NDC11Code": "52817-0268-30",
"ProductNDC": "52817-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075643",
"LabelerName": "TruPharma LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250307",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 2.5 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg tablets also contain FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow # 6/Sunset Yellow FCF aluminum lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "52817-270-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10) ",
"NDC11Code": "52817-0270-10",
"ProductNDC": "52817-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075474",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190620",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "52817-270-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30) ",
"NDC11Code": "52817-0270-30",
"ProductNDC": "52817-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075474",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190620",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "52817-271-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (52817-271-10) ",
"NDC11Code": "52817-0271-10",
"ProductNDC": "52817-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075474",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190620",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "52817-271-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-271-30) ",
"NDC11Code": "52817-0271-30",
"ProductNDC": "52817-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075474",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190620",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "52959-766-05",
"PackageDescription": "100 mL in 1 BOTTLE (52959-766-05)",
"NDC11Code": "52959-0766-05",
"ProductNDC": "52959-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19971229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074650",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is. Inactive ingredients: alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor."
},
{
"NDCCode": "52959-766-07",
"PackageDescription": "118 mL in 1 BOTTLE (52959-766-07)",
"NDC11Code": "52959-0766-07",
"ProductNDC": "52959-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19971229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074650",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is. Inactive ingredients: alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor."
},
{
"NDCCode": "54868-4576-0",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (54868-4576-0)",
"NDC11Code": "54868-4576-00",
"ProductNDC": "54868-4576",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075579",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate USP is chemically described as (±)-1-[4-[[2-(1-methylethoxy) ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide USP (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8CIN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP....................................................................................................2.5 mg. Hydrochlorothiazide USP ................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP........................................................................................................5 mg. Hydrochlorothiazide USP..................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP.....................................................................................................10 mg. Hydrochlorothiazide USP.................................................................................................6.25 mg. Inactive ingredients include: colloidal silicon dioxide, corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Both the 2.5 mg/6.25 mg and the 5 mg/6.25 mg tablets contain FD&C yellow No. 6 aluminum lake. In addition, the 5 mg/6.25 mg tablets contain FD&C red No. 40 aluminium lake."
},
{
"NDCCode": "54868-4576-1",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (54868-4576-1)",
"NDC11Code": "54868-4576-01",
"ProductNDC": "54868-4576",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075579",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate USP is chemically described as (±)-1-[4-[[2-(1-methylethoxy) ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide USP (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8CIN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP....................................................................................................2.5 mg. Hydrochlorothiazide USP ................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP........................................................................................................5 mg. Hydrochlorothiazide USP..................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP.....................................................................................................10 mg. Hydrochlorothiazide USP.................................................................................................6.25 mg. Inactive ingredients include: colloidal silicon dioxide, corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Both the 2.5 mg/6.25 mg and the 5 mg/6.25 mg tablets contain FD&C yellow No. 6 aluminum lake. In addition, the 5 mg/6.25 mg tablets contain FD&C red No. 40 aluminium lake."
}
]
}
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<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
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<LabelerName>Patheon Inc.</LabelerName>
<SubstanceName>PONATINIB HYDROCHLORIDE</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDCCode>73096-751-40</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (73096-751-40) > 40 g in 1 TUBE</PackageDescription>
<NDC11Code>73096-0751-40</NDC11Code>
<ProductNDC>73096-751</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cbdmedic Eczema Therapy</ProprietaryName>
<NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>ABACUS HEALTH PRODUCTS, INC.</LabelerName>
<SubstanceName>OATMEAL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve minor skin irritations and itching due to eczema rashes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73096-767-40</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (73096-767-40) > 40 g in 1 TUBE</PackageDescription>
<NDC11Code>73096-0767-40</NDC11Code>
<ProductNDC>73096-767</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cbdmedic Acne Treatment</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>ABACUS HEALTH PRODUCTS, INC.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For the management of acne Clears up most acne blemishes, acne pimples, blackheads, and whiteheads and allows the skin to heal.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73096-744-48</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (73096-744-48) > 48 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>73096-0744-48</NDC11Code>
<ProductNDC>73096-744</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cbdmedic Arthritis Aches And Pain Relief</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>ABACUS HEALTH PRODUCTS, INC.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of minor aches and pains of muscles and joints associated with arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73096-750-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (73096-750-04) > 103 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>73096-0750-04</NDC11Code>
<ProductNDC>73096-750</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cbdmedic Massage Therapy Pain Relief</ProprietaryName>
<NonProprietaryName>Camphor And Menthol</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>ABACUS HEALTH PRODUCTS, INC.</LabelerName>
<SubstanceName>CAMPHOR (NATURAL); MENTHOL</SubstanceName>
<StrengthNumber>31; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10135-766-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-766-01) </PackageDescription>
<NDC11Code>10135-0766-01</NDC11Code>
<ProductNDC>10135-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metolazone</ProprietaryName>
<NonProprietaryName>Metolazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216216</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOLAZONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure;, 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.</IndicationAndUsage>
<Description>Metolazone tablets, USP, for oral administration contain 2.5, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4- tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and dye: 2.5 mg - FD&C Red No. 40 and FD&C Blue No. 2; 5 mg - FD&C Blue No. 2; 10 mg - D&C Yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>10135-766-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10135-766-10) </PackageDescription>
<NDC11Code>10135-0766-10</NDC11Code>
<ProductNDC>10135-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metolazone</ProprietaryName>
<NonProprietaryName>Metolazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216216</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOLAZONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure;, 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.</IndicationAndUsage>
<Description>Metolazone tablets, USP, for oral administration contain 2.5, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4- tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and dye: 2.5 mg - FD&C Red No. 40 and FD&C Blue No. 2; 5 mg - FD&C Blue No. 2; 10 mg - D&C Yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>21695-808-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (21695-808-30)</PackageDescription>
<NDC11Code>21695-0808-30</NDC11Code>
<ProductNDC>21695-808</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075579</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate USP is chemically described as (±)-1-[4-[[2-(1-methylethoxy) ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide USP (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its molecular formula is C7H8CIN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP....................................................................................................2.5 mg. Hydrochlorothiazide USP ................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP........................................................................................................5 mg. Hydrochlorothiazide USP..................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP.....................................................................................................10 mg. Hydrochlorothiazide USP.................................................................................................6.25 mg. Inactive ingredients include: colloidal silicon dioxide, corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Both the 2.5 mg/6.25 mg and the 5 mg/6.25 mg tablets contain FD&C yellow #6 aluminum lake. In addition, the 5 mg/6.25 mg tablets contain FD&C red #40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>21695-809-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (21695-809-30)</PackageDescription>
<NDC11Code>21695-0809-30</NDC11Code>
<ProductNDC>21695-809</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075579</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate USP is chemically described as (±)-1-[4-[[2-(1-methylethoxy) ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide USP (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its molecular formula is C7H8CIN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP....................................................................................................2.5 mg. Hydrochlorothiazide USP ................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP........................................................................................................5 mg. Hydrochlorothiazide USP..................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP.....................................................................................................10 mg. Hydrochlorothiazide USP.................................................................................................6.25 mg. Inactive ingredients include: colloidal silicon dioxide, corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Both the 2.5 mg/6.25 mg and the 5 mg/6.25 mg tablets contain FD&C yellow #6 aluminum lake. In addition, the 5 mg/6.25 mg tablets contain FD&C red #40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>23155-766-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (23155-766-01) </PackageDescription>
<NDC11Code>23155-0766-01</NDC11Code>
<ProductNDC>23155-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062752</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible., 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis caused by Chlamydophila psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Klebsiella granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino) -1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. Inactive Ingredients: Lactose, and magnesium stearate. The 250 mg and 500 mg capsule shells contain D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink for the 250 mg and 500 mg capsules contains D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol, n-butyl alcohol, and ferrosoferric oxide. This product complies with USP dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50268-766-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-766-15) / 1 CAPSULE in 1 BLISTER PACK (50268-766-11) </PackageDescription>
<NDC11Code>50268-0766-15</NDC11Code>
<ProductNDC>50268-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terazosin</ProprietaryName>
<NonProprietaryName>Terazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075317</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name,molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride.C 19H 26ClN 5O 4. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Each capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochlolde. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains black iron oxide; the 2 mg capsule shell also contains D&C Yellow #10; the 5 mg capsule shell also contains D&C Yellow #10, FD&C Red #40 and D&C Red #28; the 10 mg capsule shell also contains FD&C Green #3 and D&C Yellow#10.</Description>
</NDC>
<NDC>
<NDCCode>51079-766-08</NDCCode>
<PackageDescription>80 BLISTER PACK in 1 CARTON (51079-766-08) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-766-01) </PackageDescription>
<NDC11Code>51079-0766-08</NDC11Code>
<ProductNDC>51079-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077567</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium extended-release tablets are indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium, USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release 250 and 500 mg tablets are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 or 500 mg of valproic acid. Inactive Ingredients: ammonium hydroxide, colloidal anhydrous silica, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hydroxyethyl cellulose, hypromellose, oleic acid, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide and triacetin. Meets USP Dissolution Test 3. Each 250 mg divalproex sodium extended-release tablet contains 20 mg of sodium. Each 500 mg divalproex sodium extended-release tablet contains 40 mg of sodium.</Description>
</NDC>
<NDC>
<NDCCode>51655-766-52</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-766-52) </PackageDescription>
<NDC11Code>51655-0766-52</NDC11Code>
<ProductNDC>51655-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202389</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for the: 1 treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1) , 2 treatment of generalized anxiety disorder (GAD) in adults ( 1) .</IndicationAndUsage>
<Description>Escitalopram oxalate contains escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>52817-268-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-268-30) </PackageDescription>
<NDC11Code>52817-0268-30</NDC11Code>
<ProductNDC>52817-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075643</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 2.5 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg tablets also contain FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow # 6/Sunset Yellow FCF aluminum lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>52817-270-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10) </PackageDescription>
<NDC11Code>52817-0270-10</NDC11Code>
<ProductNDC>52817-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075474</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52817-270-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30) </PackageDescription>
<NDC11Code>52817-0270-30</NDC11Code>
<ProductNDC>52817-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075474</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52817-271-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (52817-271-10) </PackageDescription>
<NDC11Code>52817-0271-10</NDC11Code>
<ProductNDC>52817-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075474</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52817-271-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-271-30) </PackageDescription>
<NDC11Code>52817-0271-30</NDC11Code>
<ProductNDC>52817-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075474</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52959-766-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (52959-766-05)</PackageDescription>
<NDC11Code>52959-0766-05</NDC11Code>
<ProductNDC>52959-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074650</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>200; 40</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is. Inactive ingredients: alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor.</Description>
</NDC>
<NDC>
<NDCCode>52959-766-07</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (52959-766-07)</PackageDescription>
<NDC11Code>52959-0766-07</NDC11Code>
<ProductNDC>52959-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074650</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>200; 40</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is. Inactive ingredients: alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor.</Description>
</NDC>
<NDC>
<NDCCode>54868-4576-0</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (54868-4576-0)</PackageDescription>
<NDC11Code>54868-4576-00</NDC11Code>
<ProductNDC>54868-4576</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075579</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate USP is chemically described as (±)-1-[4-[[2-(1-methylethoxy) ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide USP (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8CIN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP....................................................................................................2.5 mg. Hydrochlorothiazide USP ................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP........................................................................................................5 mg. Hydrochlorothiazide USP..................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP.....................................................................................................10 mg. Hydrochlorothiazide USP.................................................................................................6.25 mg. Inactive ingredients include: colloidal silicon dioxide, corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Both the 2.5 mg/6.25 mg and the 5 mg/6.25 mg tablets contain FD&C yellow No. 6 aluminum lake. In addition, the 5 mg/6.25 mg tablets contain FD&C red No. 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>54868-4576-1</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (54868-4576-1)</PackageDescription>
<NDC11Code>54868-4576-01</NDC11Code>
<ProductNDC>54868-4576</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075579</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate USP is chemically described as (±)-1-[4-[[2-(1-methylethoxy) ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide USP (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8CIN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP....................................................................................................2.5 mg. Hydrochlorothiazide USP ................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP........................................................................................................5 mg. Hydrochlorothiazide USP..................................................................................................6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP.....................................................................................................10 mg. Hydrochlorothiazide USP.................................................................................................6.25 mg. Inactive ingredients include: colloidal silicon dioxide, corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Both the 2.5 mg/6.25 mg and the 5 mg/6.25 mg tablets contain FD&C yellow No. 6 aluminum lake. In addition, the 5 mg/6.25 mg tablets contain FD&C red No. 40 aluminium lake.</Description>
</NDC>
</NDCList>