RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "72578-165-96",
      "PackageDescription": "5 TUBE in 1 CARTON (72578-165-96)  / 5 g in 1 TUBE (72578-165-05) ",
      "NDC11Code": "72578-0165-96",
      "ProductNDC": "72578-165",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine And Prilocaine",
      "NonProprietaryName": "Lidocaine And Prilocaine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219120",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "LIDOCAINE; PRILOCAINE",
      "StrengthNumber": "25; 25",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine and prilocaine cream USP, (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on. - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream are not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).",
      "Description": "Lidocaine and prilocaine cream USP, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol water partition ratio of 43 at pH 7.4 and has the following structure. Prilocaine, USP is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4 and has the following structure. Each gram of lidocaine and prilocaine cream, USP contains lidocaine 25 mg, prilocaine 25 mg, carbomer homopolymer Type B, polyoxyl 40 hydrogenated castor oil, purified water to 1 gram and sodium hydroxide to adjust to a pH approximating 9. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00."
    },
    {
      "NDCCode": "72578-165-06",
      "PackageDescription": "1 TUBE in 1 CARTON (72578-165-06)  / 30 g in 1 TUBE",
      "NDC11Code": "72578-0165-06",
      "ProductNDC": "72578-165",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine And Prilocaine",
      "NonProprietaryName": "Lidocaine And Prilocaine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219120",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "LIDOCAINE; PRILOCAINE",
      "StrengthNumber": "25; 25",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine and prilocaine cream USP, (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on. - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream are not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).",
      "Description": "Lidocaine and prilocaine cream USP, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol water partition ratio of 43 at pH 7.4 and has the following structure. Prilocaine, USP is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4 and has the following structure. Each gram of lidocaine and prilocaine cream, USP contains lidocaine 25 mg, prilocaine 25 mg, carbomer homopolymer Type B, polyoxyl 40 hydrogenated castor oil, purified water to 1 gram and sodium hydroxide to adjust to a pH approximating 9. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00."
    },
    {
      "NDCCode": "53329-165-96",
      "PackageDescription": "144 PACKET in 1 BOX (53329-165-96)  / 4 g in 1 PACKET",
      "NDC11Code": "53329-0165-96",
      "ProductNDC": "53329-165",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Remedy Calazime Skin Protectant",
      "NonProprietaryName": "Calamine, Menthol, White Petrolatum, Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120323",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Medline Industries, LP",
      "SubstanceName": "FERRIC OXIDE RED; MENTHOL; PETROLATUM; ZINC OXIDE",
      "StrengthNumber": ".5; .2; 69; 19.5",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180314",
      "EndMarketingDatePackage": "20231213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Provides temporary relief from skin irritations, itching and discomfort in the perianal area. For the temporary relief of pain. May provide a cooling sensation."
    },
    {
      "NDCCode": "72578-035-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-035-01) ",
      "NDC11Code": "72578-0035-01",
      "ProductNDC": "72578-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077060",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, USP as the active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients glyceryl behenate, hypromellose, microcrystalline cellulose and povidone. The methodology used for dissolution testing is USP Test 8 for metformin hydrochloride extended-release tablets, USP."
    },
    {
      "NDCCode": "72578-035-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-035-05) ",
      "NDC11Code": "72578-0035-05",
      "ProductNDC": "72578-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077060",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, USP as the active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients glyceryl behenate, hypromellose, microcrystalline cellulose and povidone. The methodology used for dissolution testing is USP Test 8 for metformin hydrochloride extended-release tablets, USP."
    },
    {
      "NDCCode": "72578-036-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-036-01) ",
      "NDC11Code": "72578-0036-01",
      "ProductNDC": "72578-036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077078",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, USP as the active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients glyceryl behenate, hypromellose, microcrystalline cellulose and povidone. The methodology used for dissolution testing is USP Test 8 for metformin hydrochloride extended-release tablets, USP."
    },
    {
      "NDCCode": "72578-036-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-036-05) ",
      "NDC11Code": "72578-0036-05",
      "ProductNDC": "72578-036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077078",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, USP as the active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients glyceryl behenate, hypromellose, microcrystalline cellulose and povidone. The methodology used for dissolution testing is USP Test 8 for metformin hydrochloride extended-release tablets, USP."
    },
    {
      "NDCCode": "72578-111-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (72578-111-01) ",
      "NDC11Code": "72578-0111-01",
      "ProductNDC": "72578-111",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate",
      "NonProprietaryName": "Bisoprolol Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215680",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220915",
      "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 (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 molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.96. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic and is very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 5 mg tablet contains D&C yellow #10 Aluminum Lake and FD&C red #40 Aluminum Lake. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "72578-111-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72578-111-06) ",
      "NDC11Code": "72578-0111-06",
      "ProductNDC": "72578-111",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate",
      "NonProprietaryName": "Bisoprolol Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215680",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220915",
      "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 (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 molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.96. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic and is very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 5 mg tablet contains D&C yellow #10 Aluminum Lake and FD&C red #40 Aluminum Lake. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "72578-112-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (72578-112-01) ",
      "NDC11Code": "72578-0112-01",
      "ProductNDC": "72578-112",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate",
      "NonProprietaryName": "Bisoprolol Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215680",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220915",
      "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 (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 molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.96. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic and is very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 5 mg tablet contains D&C yellow #10 Aluminum Lake and FD&C red #40 Aluminum Lake. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "72578-112-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72578-112-06) ",
      "NDC11Code": "72578-0112-06",
      "ProductNDC": "72578-112",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate",
      "NonProprietaryName": "Bisoprolol Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215680",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220915",
      "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 (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 molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.96. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic and is very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 5 mg tablet contains D&C yellow #10 Aluminum Lake and FD&C red #40 Aluminum Lake. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "72578-113-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (72578-113-01) ",
      "NDC11Code": "72578-0113-01",
      "ProductNDC": "72578-113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "2.5; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-113-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (72578-113-05) ",
      "NDC11Code": "72578-0113-05",
      "ProductNDC": "72578-113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "2.5; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-113-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72578-113-06) ",
      "NDC11Code": "72578-0113-06",
      "ProductNDC": "72578-113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "2.5; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-114-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (72578-114-01) ",
      "NDC11Code": "72578-0114-01",
      "ProductNDC": "72578-114",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "5; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-114-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (72578-114-05) ",
      "NDC11Code": "72578-0114-05",
      "ProductNDC": "72578-114",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "5; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-114-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72578-114-06) ",
      "NDC11Code": "72578-0114-06",
      "ProductNDC": "72578-114",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "5; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-115-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (72578-115-01) ",
      "NDC11Code": "72578-0115-01",
      "ProductNDC": "72578-115",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "10; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-115-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (72578-115-05) ",
      "NDC11Code": "72578-0115-05",
      "ProductNDC": "72578-115",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "10; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-115-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72578-115-06) ",
      "NDC11Code": "72578-0115-06",
      "ProductNDC": "72578-115",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215666",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "10; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 766.96. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, 1,1-dioxide. It is a white or practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.74. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 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 tablets, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..5 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP………………………….……………..10 mg. Hydrochlorothiazide, USP………………………………………..6.25 mg. Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "72578-221-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72578-221-06) ",
      "NDC11Code": "72578-0221-06",
      "ProductNDC": "72578-221",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prucalopride",
      "NonProprietaryName": "Prucalopride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218056",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "PRUCALOPRIDE SUCCINATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.",
      "Description": "Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9. Each 1 mg and 2 mg film-coated prucalopride tablet contains prucalopride equivalent to 1.32 mg and 2.64 mg of prucalopride succinate respectively for oral administration and contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide and triacetin. Additionally, 2 mg tablets contain iron oxide yellow and iron oxide red."
    },
    {
      "NDCCode": "72578-222-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72578-222-06) ",
      "NDC11Code": "72578-0222-06",
      "ProductNDC": "72578-222",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prucalopride",
      "NonProprietaryName": "Prucalopride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218056",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "PRUCALOPRIDE SUCCINATE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.",
      "Description": "Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9. Each 1 mg and 2 mg film-coated prucalopride tablet contains prucalopride equivalent to 1.32 mg and 2.64 mg of prucalopride succinate respectively for oral administration and contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide and triacetin. Additionally, 2 mg tablets contain iron oxide yellow and iron oxide red."
    },
    {
      "NDCCode": "12634-756-96",
      "PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE (12634-756-96)",
      "NDC11Code": "12634-0756-96",
      "ProductNDC": "12634-756",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091184",
      "LabelerName": "Apotheca Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "IndicationAndUsage": "Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-­dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol."
    },
    {
      "NDCCode": "12634-757-96",
      "PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE (12634-757-96)",
      "NDC11Code": "12634-0757-96",
      "ProductNDC": "12634-757",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091184",
      "LabelerName": "Apotheca Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "850",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "IndicationAndUsage": "Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-­dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol."
    },
    {
      "NDCCode": "12634-789-96",
      "PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE (12634-789-96)",
      "NDC11Code": "12634-0789-96",
      "ProductNDC": "12634-789",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091184",
      "LabelerName": "Apotheca Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "IndicationAndUsage": "Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-­dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol."
    },
    {
      "NDCCode": "43353-082-96",
      "PackageDescription": "450 TABLET in 1 BOTTLE (43353-082-96) ",
      "NDC11Code": "43353-0082-96",
      "ProductNDC": "43353-082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203769",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "850",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Tablets USP, are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white crystalline compound with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
    },
    {
      "NDCCode": "43353-340-96",
      "PackageDescription": "450 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-340-96)",
      "NDC11Code": "43353-0340-96",
      "ProductNDC": "43353-340",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075985",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N, N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each metformin hydrochloride tablet intended for oral administration contains 500 mg, 850 mg or 1000 mg metformin hydrochloride. In addition, each metformin hydrochloride tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "43353-842-96",
      "PackageDescription": "450 TABLET in 1 BOTTLE, PLASTIC (43353-842-96) ",
      "NDC11Code": "43353-0842-96",
      "ProductNDC": "43353-842",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120626",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077880",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Metformin HCL Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride (HCl) Tablets, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin HCl, USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin HCl, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5  HCl and a molecular weight of 165.62. Metformin HCl, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin HCl, USP is 6.68. Metformin HCL Tablets, USP, contains 500 mg, 850 mg, or 1000 mg of Metformin HCl, USP. Each tablet contains the inactive ingredients povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contain polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, gum acacia, maltodextrin, propylene glycol and natural flavors."
    },
    {
      "NDCCode": "43353-982-96",
      "PackageDescription": "450 TABLET in 1 BOTTLE (43353-982-96) ",
      "NDC11Code": "43353-0982-96",
      "ProductNDC": "43353-982",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203769",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150328",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Tablets USP, are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
    },
    {
      "NDCCode": "43353-987-96",
      "PackageDescription": "450 TABLET in 1 BOTTLE (43353-987-96) ",
      "NDC11Code": "43353-0987-96",
      "ProductNDC": "43353-987",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203769",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Tablets USP, are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
    }
  ]
}
                    

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