RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "49288-0286-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0286-4)",
      "NDC11Code": "49288-0286-04",
      "ProductNDC": "49288-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lettuce",
      "NonProprietaryName": "Lettuce",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "LETTUCE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Non-Standardized Food Allergenic Extract [EPC],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "13630-0286-4",
      "PackageDescription": "142 g in 1 CAN (13630-0286-4) ",
      "NDC11Code": "13630-0286-04",
      "ProductNDC": "13630-0286",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Defense Zone",
      "ProprietaryNameSuffix": "Sport C/s Broad Spectrum Spf 30",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Oxybenzone",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240502",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Prime Packaging Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": ".03; .1; .05; .04",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240502",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
    },
    {
      "NDCCode": "15631-0286-4",
      "PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0286-4) ",
      "NDC11Code": "15631-0286-04",
      "ProductNDC": "15631-0286",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Manganum Muriaticum",
      "NonProprietaryName": "Manganum Muriaticum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150909",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "MANGANESE CHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20160104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "37662-0286-4",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0286-4) ",
      "NDC11Code": "37662-0286-04",
      "ProductNDC": "37662-0286",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Chromium Sulphuricum",
      "NonProprietaryName": "Chromium Sulphuricum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220602",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CHROMIC SULFATE",
      "StrengthNumber": "100",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-06-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220602",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71335-0286-4",
      "PackageDescription": "120 TABLET in 1 BOTTLE (71335-0286-4) ",
      "NDC11Code": "71335-0286-04",
      "ProductNDC": "71335-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mirtazapine",
      "NonProprietaryName": "Mirtazapine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040422",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076541",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "MIRTAZAPINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2023-10-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
      "Description": "Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black)."
    },
    {
      "NDCCode": "49288-0286-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0286-1)",
      "NDC11Code": "49288-0286-01",
      "ProductNDC": "49288-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lettuce",
      "NonProprietaryName": "Lettuce",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "LETTUCE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Non-Standardized Food Allergenic Extract [EPC],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0286-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0286-2)",
      "NDC11Code": "49288-0286-02",
      "ProductNDC": "49288-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lettuce",
      "NonProprietaryName": "Lettuce",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "LETTUCE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Non-Standardized Food Allergenic Extract [EPC],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0286-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0286-3)",
      "NDC11Code": "49288-0286-03",
      "ProductNDC": "49288-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lettuce",
      "NonProprietaryName": "Lettuce",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "LETTUCE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Non-Standardized Food Allergenic Extract [EPC],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0286-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0286-5)",
      "NDC11Code": "49288-0286-05",
      "ProductNDC": "49288-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lettuce",
      "NonProprietaryName": "Lettuce",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "LETTUCE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Non-Standardized Food Allergenic Extract [EPC],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "0126-0286-66",
      "PackageDescription": "1 TUBE in 1 CARTON (0126-0286-66)  / 51 g in 1 TUBE",
      "NDC11Code": "00126-0286-66",
      "ProductNDC": "0126-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevident",
      "ProprietaryNameSuffix": "5000 Plus Fruitastic",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20120829",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Colgate Oral Pharmaceuticals Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "11",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120829",
      "SamplePackage": "N",
      "IndicationAndUsage": "A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Prevident® 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (see WARNINGS for exception).",
      "Description": "Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients."
    },
    {
      "NDCCode": "0597-0286-30",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0597-0286-30)  / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00597-0286-30",
      "ProductNDC": "0597-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mirapex",
      "ProprietaryNameSuffix": "Er",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110618",
      "EndMarketingDate": "20240831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022421",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": "2.25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110618",
      "EndMarketingDatePackage": "20240831",
      "SamplePackage": "N",
      "IndicationAndUsage": "MIRAPEX ER® tablets are indicated for the treatment of Parkinson's disease.",
      "Description": "MIRAPEX ER tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S ∙ 2HCl ∙ H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. MIRAPEX ER tablets 0.375 mg. Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride. MIRAPEX ER tablets 0.75 mg. Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. MIRAPEX ER tablets 1.5 mg. Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. MIRAPEX ER tablets 2.25 mg. Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride. MIRAPEX ER tablets 3 mg. Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride. MIRAPEX ER tablets 3.75 mg. Each extended-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 3.53 mg pramipexole dihydrochloride. MIRAPEX ER tablets 4.5 mg. Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of MIRAPEX ER tablets consist of carbomer homopolymer, colloidal silicon dioxide, corn starch, hypromellose, and magnesium stearate."
    },
    {
      "NDCCode": "0924-0286-01",
      "PackageDescription": "20 PACKET in 1 BOX, UNIT-DOSE (0924-0286-01)  > 2 TABLET, CHEWABLE in 1 PACKET",
      "NDC11Code": "00924-0286-01",
      "ProductNDC": "0924-0286",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "First Aid Only Antacid",
      "NonProprietaryName": "Calcium Carbonate",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081230",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "Acme United Corporation",
      "SubstanceName": "CALCIUM CARBONATE",
      "StrengthNumber": "420",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180328",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves: 1 acid indigestion, 2 sour stomach, 3 heartburn, 4 upset stomach associated with these symptoms."
    },
    {
      "NDCCode": "11673-286-01",
      "PackageDescription": "1 KIT in 1 CARTON (11673-286-01)  *  180 mL in 1 BOTTLE (11673-872-03)  *  180 mL in 1 BOTTLE (11673-295-03) ",
      "NDC11Code": "11673-0286-01",
      "ProductNDC": "11673-286",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Maximum Strength Daytime Cold And Flu And Nighttime Severe Cold And Flu",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride,triprolidine Hydrochloride",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "TARGET CORPORATION",
      "Status": "Active",
      "LastUpdate": "2024-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240501",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: 1 cough, 2 nasal congestion, 3 minor aches and pains, 4 sore throat, 5 headache, 6 stuffy nose, 7 sinus congestion and pressure."
    },
    {
      "NDCCode": "13537-286-20",
      "PackageDescription": "1 TUBE in 1 BOX (13537-286-20)  > 4 g in 1 TUBE (13537-286-19)",
      "NDC11Code": "13537-0286-20",
      "ProductNDC": "13537-286",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esika Extreme Moisturizing Spf 16",
      "ProprietaryNameSuffix": "(naranja Primavera) - Red",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131216",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".066; .015",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "16729-286-15",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16729-286-15) ",
      "NDC11Code": "16729-0286-15",
      "ProductNDC": "16729-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rosuvastatin",
      "NonProprietaryName": "Rosuvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206434",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "ROSUVASTATIN CALCIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of ,major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP)≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce LDL-C and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
      "Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of  0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients. For 5 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, and ferric oxide yellow. For 10, 20 and 40 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD & C yellow No. 6, FD & C red No. 40, and FD & C blue No.1. Rosuvastatin tablets, USP meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "16729-286-17",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-286-17) ",
      "NDC11Code": "16729-0286-17",
      "ProductNDC": "16729-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rosuvastatin",
      "NonProprietaryName": "Rosuvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206434",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "ROSUVASTATIN CALCIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of ,major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP)≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce LDL-C and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
      "Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of  0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients. For 5 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, and ferric oxide yellow. For 10, 20 and 40 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD & C yellow No. 6, FD & C red No. 40, and FD & C blue No.1. Rosuvastatin tablets, USP meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "17856-0286-1",
      "PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0286-1)  > 10 mL in 1 CUP, UNIT-DOSE",
      "NDC11Code": "17856-0286-01",
      "ProductNDC": "17856-0286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091678",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levofloxacin oral solution is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.",
      "Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4  ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Forms. Levofloxacin Oral Solution. Levofloxacin Oral Solution, 25 mg/mL, is a multi-use self-preserving aqueous solution of levofloxacin with pH ranging from 5.0 to 6.0. The appearance of Levofloxacin Oral Solution may range from clear yellow to clear greenish-yellow. This does not adversely affect product potency. Levofloxacin Oral Solution contains the following inactive ingredients: artificial bubble gum flavor, artificial grape flavor, ascorbic acid, benzyl alcohol, glycerin, hydrochloric acid, PFC Bitter Mask F-9885, propylene glycol, purified water, saccharin sodium, and sucrose. Sodium hydroxide may be used to adjust pH."
    },
    {
      "NDCCode": "27241-286-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (27241-286-01) ",
      "NDC11Code": "27241-0286-01",
      "ProductNDC": "27241-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prochlorperazine Maleate",
      "NonProprietaryName": "Prochlorperazine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240509",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218515",
      "LabelerName": "Ajanta Pharma USA Inc.",
      "SubstanceName": "PROCHLORPERAZINE MALEATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240509",
      "SamplePackage": "N",
      "IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).  Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.",
      "Description": "Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methylpiperazin-1 -yl)propyl] phenothiazine maleate (1:2) [molecular weight 606.09] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water, and in alcohol (96% ethanol). Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients:  lactose monohydrate, microcrystalline cellulose, pregelatinized starch, stearic acid, magnesium stearate. Film coating: Opadry 13F520021 yellow contains hydroxypropyl methylcellulose 2910/hypromellose, D&C yellow#10 aluminium lake, macrogol/polyethylene glycol, titanium dioxide, polysorbate 80, FD&C blue#2/ indigo carmine aluminium lake and FD&C yellow#6/ sunset yellow FCF aluminium lake. Prochlorperazine maleate tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "29300-286-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-286-01) ",
      "NDC11Code": "29300-0286-01",
      "ProductNDC": "29300-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190326",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209250",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190326",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil Tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1   erectile dysfunction (ED) (1.1), 2   the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3   ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
      "Description": "Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil Tablets USP are available as oval / almond shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients : Lactose monohydrate, Microcrystalline Cellulose, Sodium Lauryl Sulphate, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc and Yellow iron oxide. In addition, Tadalafil Tablets, 2.5 mg and 10 mg contains Red iron oxide."
    },
    {
      "NDCCode": "29300-286-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-286-05) ",
      "NDC11Code": "29300-0286-05",
      "ProductNDC": "29300-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190326",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209250",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190326",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil Tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1   erectile dysfunction (ED) (1.1), 2   the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3   ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
      "Description": "Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil Tablets USP are available as oval / almond shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients : Lactose monohydrate, Microcrystalline Cellulose, Sodium Lauryl Sulphate, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc and Yellow iron oxide. In addition, Tadalafil Tablets, 2.5 mg and 10 mg contains Red iron oxide."
    },
    {
      "NDCCode": "29300-286-13",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-286-13) ",
      "NDC11Code": "29300-0286-13",
      "ProductNDC": "29300-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190326",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209250",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190326",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil Tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1   erectile dysfunction (ED) (1.1), 2   the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3   ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
      "Description": "Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil Tablets USP are available as oval / almond shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients : Lactose monohydrate, Microcrystalline Cellulose, Sodium Lauryl Sulphate, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc and Yellow iron oxide. In addition, Tadalafil Tablets, 2.5 mg and 10 mg contains Red iron oxide."
    },
    {
      "NDCCode": "29300-286-82",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (29300-286-82)  / 15 TABLET, FILM COATED in 1 BLISTER PACK (29300-286-51) ",
      "NDC11Code": "29300-0286-82",
      "ProductNDC": "29300-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190326",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209250",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190326",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil Tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1   erectile dysfunction (ED) (1.1), 2   the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3   ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
      "Description": "Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil Tablets USP are available as oval / almond shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients : Lactose monohydrate, Microcrystalline Cellulose, Sodium Lauryl Sulphate, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc and Yellow iron oxide. In addition, Tadalafil Tablets, 2.5 mg and 10 mg contains Red iron oxide."
    },
    {
      "NDCCode": "31722-286-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (31722-286-01) ",
      "NDC11Code": "31722-0286-01",
      "ProductNDC": "31722-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215259",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": ".075",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test."
    },
    {
      "NDCCode": "31722-286-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (31722-286-10) ",
      "NDC11Code": "31722-0286-10",
      "ProductNDC": "31722-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215259",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": ".075",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test."
    },
    {
      "NDCCode": "31722-286-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (31722-286-30) ",
      "NDC11Code": "31722-0286-30",
      "ProductNDC": "31722-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215259",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": ".075",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test."
    },
    {
      "NDCCode": "31722-286-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (31722-286-90) ",
      "NDC11Code": "31722-0286-90",
      "ProductNDC": "31722-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215259",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": ".075",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test."
    },
    {
      "NDCCode": "33342-286-07",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-286-07) ",
      "NDC11Code": "33342-0286-07",
      "ProductNDC": "33342-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine,valsartan And Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine,valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207299",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "10; 160; 25",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250106",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitation of Use Amlodipine, valsartan and hydrochlorothiazide tablet is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].",
      "Description": "Amlodipine, valsartan and hydrochlorothiazide tablets, USP are a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Amlodipine, valsartan and hydrochlorothiazide tablets, USP contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is. Its molecular formula is C20H25ClN2O5.C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2´-(1H-tetrazol-5-yl) [1,1´-biphenyl]-4yl]methyl]-L-valine; its structural formula is. Its molecular formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Amlodipine, valsartan and hydrochlorothiazide film-coated tablets, USP are formulated in 5 strengths for oral administration with a combination of amlodipine besylate, valsartan, and hydrochlorothiazide, providing for the following available combinations. 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
    },
    {
      "NDCCode": "33342-286-10",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (33342-286-10) ",
      "NDC11Code": "33342-0286-10",
      "ProductNDC": "33342-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine,valsartan And Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine,valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207299",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "10; 160; 25",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250106",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitation of Use Amlodipine, valsartan and hydrochlorothiazide tablet is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].",
      "Description": "Amlodipine, valsartan and hydrochlorothiazide tablets, USP are a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Amlodipine, valsartan and hydrochlorothiazide tablets, USP contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is. Its molecular formula is C20H25ClN2O5.C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2´-(1H-tetrazol-5-yl) [1,1´-biphenyl]-4yl]methyl]-L-valine; its structural formula is. Its molecular formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Amlodipine, valsartan and hydrochlorothiazide film-coated tablets, USP are formulated in 5 strengths for oral administration with a combination of amlodipine besylate, valsartan, and hydrochlorothiazide, providing for the following available combinations. 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
    },
    {
      "NDCCode": "33342-286-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-286-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "33342-0286-12",
      "ProductNDC": "33342-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine,valsartan And Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine,valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250106",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207299",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "10; 160; 25",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250106",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitation of Use Amlodipine, valsartan and hydrochlorothiazide tablet is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].",
      "Description": "Amlodipine, valsartan and hydrochlorothiazide tablets, USP are a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Amlodipine, valsartan and hydrochlorothiazide tablets, USP contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is. Its molecular formula is C20H25ClN2O5.C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2´-(1H-tetrazol-5-yl) [1,1´-biphenyl]-4yl]methyl]-L-valine; its structural formula is. Its molecular formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Amlodipine, valsartan and hydrochlorothiazide film-coated tablets, USP are formulated in 5 strengths for oral administration with a combination of amlodipine besylate, valsartan, and hydrochlorothiazide, providing for the following available combinations. 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
    },
    {
      "NDCCode": "35561-286-00",
      "PackageDescription": "129032 TABLET, FILM COATED in 1 BOX (35561-286-00) ",
      "NDC11Code": "35561-0286-00",
      "ProductNDC": "35561-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Solifenacin Succinate",
      "NonProprietaryName": "Solifenacin Succinate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190520",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210281",
      "LabelerName": "Bostal LLC",
      "SubstanceName": "SOLIFENACIN SUCCINATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190520",
      "SamplePackage": "N",
      "IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
      "Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide."
    }
  ]
}
                    

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