RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "71897-523-40",
      "PackageDescription": "1200 mL in 1 PACKAGE (71897-523-40) ",
      "NDC11Code": "71897-0523-40",
      "ProductNDC": "71897-523",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Reliable Hand So Ap Antibacterial Plum",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180615",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Veritiv Operating Company",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".005",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180615",
      "SamplePackage": "N",
      "IndicationAndUsage": " Handwash to help decrease bacteria on the skin.  Recommended for repeated use."
    },
    {
      "NDCCode": "71897-080-40",
      "PackageDescription": "1200 mL in 1 PACKAGE (71897-080-40) ",
      "NDC11Code": "71897-0080-40",
      "ProductNDC": "71897-080",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Reliable Luxury Foam Antimicrobial Handwash Fresh Fruit Scent",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20030115",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Veritiv Operating Company",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".003",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20030115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Handwash to help decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "71897-082-40",
      "PackageDescription": "1200 mL in 1 PACKAGE (71897-082-40) ",
      "NDC11Code": "71897-0082-40",
      "ProductNDC": "71897-082",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Unisource Peach Antimicrobial Foam",
      "NonProprietaryName": "Chloroxylenol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20060630",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Veritiv Operating Company",
      "SubstanceName": "CHLOROXYLENOL",
      "StrengthNumber": ".003",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20060630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Handwash to help decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "71897-114-40",
      "PackageDescription": "1200 mL in 1 PACKAGE (71897-114-40) ",
      "NDC11Code": "71897-0114-40",
      "ProductNDC": "71897-114",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Reliable Brand Powered By Purell Antimicrobial Fragrance Free Foam Cb10 1.2l",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20231205",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Veritiv Operating Company",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".0013",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231205",
      "SamplePackage": "N",
      "IndicationAndUsage": " Handwash to help decrease bacteria on the skin.  Recommended for repeated use."
    },
    {
      "NDCCode": "71897-400-40",
      "PackageDescription": "1200 mL in 1 PACKAGE (71897-400-40) ",
      "NDC11Code": "71897-0400-40",
      "ProductNDC": "71897-400",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Unisource Antibacterial Foam Handwash Plum",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170430",
      "EndMarketingDate": "20231231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Veritiv Operating Company",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".005",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170430",
      "EndMarketingDatePackage": "20231231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71897-401-40",
      "PackageDescription": "1200 mL in 1 PACKAGE (71897-401-40) ",
      "NDC11Code": "71897-0401-40",
      "ProductNDC": "71897-401",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Reliable Luxury Foam Antimicrobial Handwash Citrus Floral Scent",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170430",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Veritiv Operating Company",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".005",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170430",
      "SamplePackage": "N",
      "IndicationAndUsage": " Handwash to help decrease bacteria on the skin.  Recommended for repeated use."
    },
    {
      "NDCCode": "71897-610-40",
      "PackageDescription": "1200 mL in 1 PACKAGE (71897-610-40) ",
      "NDC11Code": "71897-0610-40",
      "ProductNDC": "71897-610",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Reliable Brand Powered By Purell Antimicrobial Scented Foam Cb10 1.2l",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20231205",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Veritiv Operating Company",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/100mL",
      "Status": "Active",
      "LastUpdate": "2025-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231205",
      "SamplePackage": "N",
      "IndicationAndUsage": " Handwash to help decrease bacteria on the skin."
    },
    {
      "NDCCode": "54838-523-40",
      "PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (54838-523-40) ",
      "NDC11Code": "54838-0523-40",
      "ProductNDC": "54838-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine",
      "NonProprietaryName": "Fluoxetine Hydrochloride",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090827",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077849",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090827",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluoxetine oral solution is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]., 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]., 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]., 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].",
      "Description": "Fluoxetine Oral Solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg per 5 mL (64.7 µmol) of fluoxetine. It also contains the following inactive ingredients: alcohol 0.23%, benzoic acid, spearmint flavor, glycerin, purified water, and sucrose."
    },
    {
      "NDCCode": "55289-523-40",
      "PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (55289-523-40) ",
      "NDC11Code": "55289-0523-40",
      "ProductNDC": "55289-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alprazolam",
      "NonProprietaryName": "Alprazolam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980325",
      "EndMarketingDate": "20270319",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074909",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "ALPRAZOLAM",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160304",
      "EndMarketingDatePackage": "20270319",
      "SamplePackage": "N",
      "IndicationAndUsage": "Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
      "Description": "Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mgalso contains FD&C Yellow #6 Aluminum Lake, and the 1 mgalso contains FD&C Blue #2 Aluminum Lake."
    },
    {
      "NDCCode": "69423-523-40",
      "PackageDescription": "400 mL in 1 BOTTLE, PLASTIC (69423-523-40) ",
      "NDC11Code": "69423-0523-40",
      "ProductNDC": "69423-523",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders Clinical Strength Dandruff Defense Dry Scalp Rescue",
      "NonProprietaryName": "Selenium Sulfide",
      "DosageFormName": "LOTION/SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201117",
      "EndMarketingDate": "20261201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "SELENIUM SULFIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20201117",
      "EndMarketingDatePackage": "20261201",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis."
    },
    {
      "NDCCode": "69423-673-01",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (69423-673-01)  *  400 mL in 1 BOTTLE, PLASTIC (69423-523-40)  *  270 mL in 1 TUBE (69423-568-27) ",
      "NDC11Code": "69423-0673-01",
      "ProductNDC": "69423-673",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders Clinical Dry Scalp Rescue Kit",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230315",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230315",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72288-523-02",
      "PackageDescription": "1 KIT in 1 PACKAGE (72288-523-02)  *  355 mL in 1 BOTTLE (72288-599-40)  *  355 mL in 1 BOTTLE (72288-943-40) ",
      "NDC11Code": "72288-0523-02",
      "ProductNDC": "72288-523",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Basic Care Daytime Nighttime Severe Cold And Flu",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride,guaifenesin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20220812",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Amazon.com Services LLC",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220812",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73117-523-19",
      "PackageDescription": "40 mL in 1 BOX (73117-523-19) ",
      "NDC11Code": "73117-0523-19",
      "ProductNDC": "73117-523",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nebuclear Md",
      "NonProprietaryName": "Racepinephrine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20260501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Blue Echo Care LLC",
      "SubstanceName": "RACEPINEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "11.25",
      "StrengthUnit": "mg/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of mild symptoms of intermittent asthma. Wheezing Tightness of chest Shortness of breath."
    },
    {
      "NDCCode": "10812-523-01",
      "PackageDescription": "141 g in 1 CAN (10812-523-01)",
      "NDC11Code": "10812-0523-01",
      "ProductNDC": "10812-523",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Ultimate Sport",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf70 Plus",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120912",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Neutrogena Corporation",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "30; 150; 50; 40; 60",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "37808-523-04",
      "PackageDescription": "4 PATCH in 1 PACKAGE (37808-523-04) ",
      "NDC11Code": "37808-0523-04",
      "ProductNDC": "37808-523",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Salicylic Acid",
      "NonProprietaryName": "Medicated Callus Removers",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171222",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M030",
      "LabelerName": "HEB",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/41",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20171222",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the removal of calluses. relieves pain by removing calluses."
    },
    {
      "NDCCode": "51759-523-21",
      "PackageDescription": "1 KIT in 1 CARTON (51759-523-21)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (51759-634-31)  *  .4 mL in 1 POUCH (65517-0002-1) ",
      "NDC11Code": "51759-0523-21",
      "ProductNDC": "51759-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simlandi",
      "NonProprietaryName": "Adalimumab-ryvk",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20250129",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761299",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250129",
      "SamplePackage": "N",
      "IndicationAndUsage": "SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older (1.9).",
      "Description": "Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-ryvk is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. SIMLANDI® (adalimumab-ryvk) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SIMLANDI autoinjector or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of SIMLANDI is clear and colorless, with a pH of 5.0-5.6. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of SIMLANDI contains adalimumab-ryvk (80 mg), polysorbate 80 (0.80 mg), sodium chloride (0.47 mg), sucrose (69.83 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of SIMLANDI contains adalimumab-ryvk (40 mg), polysorbate 80 (0.40 mg), sodium chloride (0.23 mg), sucrose (34.9 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of SIMLANDI contains adalimumab-ryvk (20 mg), polysorbate 80 (0.20 mg), sodium chloride (0.12 mg), sucrose (17.46 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH."
    },
    {
      "NDCCode": "61919-523-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (61919-523-30) ",
      "NDC11Code": "61919-0523-30",
      "ProductNDC": "61919-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril/hctz",
      "NonProprietaryName": "Lisinopril/hctz",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190807",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076194",
      "LabelerName": "Direct_Rx",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
      "StrengthNumber": "12.5; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190807",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisinopril and Hydrochlorothiazide Tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 lisinopril and hydrochlorothiazide. 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 (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using Lisinopril and Hydrochlorothiazide Tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering use of Lisinopril and Hydrochlorothiazide Tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non- Blacks. (See WARNINGS, Head and Neck Angioedema.).",
      "Description": "Lisinopril and Hydrochlorothiazide Tablets, USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Structural Formula of Lisinopril]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. [Structural Formula of Hydrochlorothiazide]. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and Hydrochlorothiazide Tablets, USP is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and Hydrochlorothiazide Tablets, USP 10-12.5, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide USP and Lisinopril and Hydrochlorothiazide Tablets, USP 20-12.5, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide USP and Lisinopril and Hydrochlorothiazide Tablets 20-25, containing 20 mg lisinopril and 25 mg hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (20 mg/12.5 mg only), FD&C Red #40 Aluminum Lake (10 mg/12.5 mg, and 20 mg/25 mg), magnesium stearate, mannitol, and pregelatinized starch."
    },
    {
      "NDCCode": "68382-523-05",
      "PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-523-05) ",
      "NDC11Code": "68382-0523-05",
      "ProductNDC": "68382-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propafenone Hydrochloride",
      "NonProprietaryName": "Propafenone Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214184",
      "LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
      "SubstanceName": "PROPAFENONE HYDROCHLORIDE",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF., 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see Boxed Warning] .",
      "Description": "Propafenone hydrochloride, USP is an antiarrhythmic drug supplied in extended-release capsules of 225 mg, 325 mg, and 425 mg for oral administration. Chemically, propafenone hydrochloride, USP is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.9. The molecular formula is C21H27NO3HCl. Propafenone hydrochloride, USP has some structural similarities to beta-blocking agents. The structural formula of propafenone hydrochloride, USP is given below. Propafenone hydrochloride, USP occurs as white powder. It is soluble in hot water and methanol and slightly soluble in chloroform. Propafenone hydrochloride extended-release capsules, USP are filled with white to off-white minitablets containing propafenone hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate and silicon dioxide. In addition, each capsule contains gelatin, sodium lauryl sulphate and titanium dioxide. The 325 mg capsules also contain FD&C Blue 1 and FD & C Red 40. The 425 mg capsules also contain FD & C Red 3, FD & C Red 40 and FD & C Yellow 6. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution method and acceptance criterion differ from the USP dissolution specification."
    },
    {
      "NDCCode": "68382-523-14",
      "PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-523-14) ",
      "NDC11Code": "68382-0523-14",
      "ProductNDC": "68382-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propafenone Hydrochloride",
      "NonProprietaryName": "Propafenone Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214184",
      "LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
      "SubstanceName": "PROPAFENONE HYDROCHLORIDE",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF., 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see Boxed Warning] .",
      "Description": "Propafenone hydrochloride, USP is an antiarrhythmic drug supplied in extended-release capsules of 225 mg, 325 mg, and 425 mg for oral administration. Chemically, propafenone hydrochloride, USP is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.9. The molecular formula is C21H27NO3HCl. Propafenone hydrochloride, USP has some structural similarities to beta-blocking agents. The structural formula of propafenone hydrochloride, USP is given below. Propafenone hydrochloride, USP occurs as white powder. It is soluble in hot water and methanol and slightly soluble in chloroform. Propafenone hydrochloride extended-release capsules, USP are filled with white to off-white minitablets containing propafenone hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate and silicon dioxide. In addition, each capsule contains gelatin, sodium lauryl sulphate and titanium dioxide. The 325 mg capsules also contain FD&C Blue 1 and FD & C Red 40. The 425 mg capsules also contain FD & C Red 3, FD & C Red 40 and FD & C Yellow 6. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution method and acceptance criterion differ from the USP dissolution specification."
    },
    {
      "NDCCode": "72189-523-08",
      "PackageDescription": "8 TABLET in 1 BOTTLE (72189-523-08) ",
      "NDC11Code": "72189-0523-08",
      "ProductNDC": "72189-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone",
      "NonProprietaryName": "Dexamethasone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217696",
      "LabelerName": "Direct_Rx",
      "SubstanceName": "DEXAMETHASONE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
      "Description": "Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 0.5 mg, 0.75 mg, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (0.75 mg, 4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Yellow #6 Aluminum Lake (0.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), D&C Yellow #10 Aluminum Lake (0.5 mg, 0.75 mg, 1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is. [structure]. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "72189-523-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (72189-523-15) ",
      "NDC11Code": "72189-0523-15",
      "ProductNDC": "72189-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone",
      "NonProprietaryName": "Dexamethasone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217696",
      "LabelerName": "Direct_Rx",
      "SubstanceName": "DEXAMETHASONE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
      "Description": "Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 0.5 mg, 0.75 mg, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (0.75 mg, 4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Yellow #6 Aluminum Lake (0.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), D&C Yellow #10 Aluminum Lake (0.5 mg, 0.75 mg, 1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is. [structure]. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "72789-523-30",
      "PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-523-30) ",
      "NDC11Code": "72789-0523-30",
      "ProductNDC": "72789-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204453",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "45",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250910",
      "SamplePackage": "N",
      "IndicationAndUsage": "Minocycline hydrochloride extended-release tablets is indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies ( 14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions ( 5.12)]. .",
      "Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4 S-(4α,4aα,5aα, 12aα)]-4,7–Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. C 23H 27N 3O 7HCl    M. W. 493.95. Minocycline hydrochloride extended-release tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black. The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake. polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6. The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake. The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. The USP Dissolution Test is pending."
    },
    {
      "NDCCode": "76282-523-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (76282-523-30) ",
      "NDC11Code": "76282-0523-30",
      "ProductNDC": "76282-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lurasidone Hydrochloride",
      "NonProprietaryName": "Lurasidone Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208028",
      "LabelerName": "Exelan Pharmaceuticals Inc.",
      "SubstanceName": "LURASIDONE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lurasidone hydrochloride tablets are indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].",
      "Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, corn starch, hydroxy Propyl methyl cellulose, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypermellose, polyethelene glycol, polysorbate and additionally 80 mg tablets contains yellow iron oxide and FDC Blue #2/Indigotine Aluminum lake (12 to 14% dye)."
    },
    {
      "NDCCode": "76420-523-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (76420-523-01) ",
      "NDC11Code": "76420-0523-01",
      "ProductNDC": "76420-523",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prazosin Hydrochloride",
      "NonProprietaryName": "Prazosin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215697",
      "LabelerName": "ASCLEMED USA INC.",
      "SubstanceName": "PRAZOSIN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251015",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program'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 (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
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      "Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula:  C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
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      "Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula:  C 19H 21N 5O 4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
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}
                    

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