RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (10 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0597-0545-66",
      "PackageDescription": "6 KIT in 1 CARTON (0597-0545-66)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (0597-0540-10)  / .8 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET",
      "NDC11Code": "00597-0545-66",
      "ProductNDC": "0597-0545",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adalimumab-adbm",
      "NonProprietaryName": "Adalimumab-adbm",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231001",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761058",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20231001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Plaque Psoriasis (Ps) (1.7): 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., 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
      "Description": "Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody 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. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP."
    },
    {
      "NDCCode": "0597-0545-22",
      "PackageDescription": "2 KIT in 1 CARTON (0597-0545-22)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (0597-0540-10)  / .8 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET",
      "NDC11Code": "00597-0545-22",
      "ProductNDC": "0597-0545",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adalimumab-adbm",
      "NonProprietaryName": "Adalimumab-adbm",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231001",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761058",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adalimumab-adbm 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-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody 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. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP."
    },
    {
      "NDCCode": "0597-0545-44",
      "PackageDescription": "4 KIT in 1 CARTON (0597-0545-44)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (0597-0540-10)  / .8 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET",
      "NDC11Code": "00597-0545-44",
      "ProductNDC": "0597-0545",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adalimumab-adbm",
      "NonProprietaryName": "Adalimumab-adbm",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231001",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761058",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231001",
      "EndMarketingDatePackage": "20250930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Plaque Psoriasis (Ps) (1.7): 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., 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
      "Description": "Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody 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. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP."
    },
    {
      "NDCCode": "62756-545-66",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (62756-545-66)  > 5 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "62756-0545-66",
      "ProductNDC": "62756-545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fexofenadine Hydrochloride",
      "NonProprietaryName": "Fexofenadine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091567",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20120206",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "63824-545-66",
      "PackageDescription": "180 mL in 1 BOTTLE (63824-545-66)",
      "NDC11Code": "63824-0545-66",
      "ProductNDC": "63824-545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucinex Fast-max",
      "ProprietaryNameSuffix": "Congestion And Headache Clear And Cool",
      "NonProprietaryName": "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160701",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Reckitt Benckiser LLC",
      "SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "650; 400; 10",
      "StrengthUnit": "mg/20mL; mg/20mL; mg/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0597-0121-66",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0597-0121-66)  > 40 TABLET, COATED in 1 BOTTLE",
      "NDC11Code": "00597-0121-66",
      "ProductNDC": "0597-0121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Maximum Strength Zantac",
      "NonProprietaryName": "Ranitidine",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061221",
      "EndMarketingDate": "20211130",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021698",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals Inc.",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20061221",
      "EndMarketingDatePackage": "20211130",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0597-0146-66",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (0597-0146-66) ",
      "NDC11Code": "00597-0146-66",
      "ProductNDC": "0597-0146",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Jentadueto",
      "NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120213",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201281",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "2.5; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120213",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "JENTADUETO tablets for oral use contain: linagliptin and metformin HCl."
    },
    {
      "NDCCode": "0597-0147-66",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (0597-0147-66) ",
      "NDC11Code": "00597-0147-66",
      "ProductNDC": "0597-0147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Jentadueto",
      "NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120213",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201281",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "2.5; 850",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20120213",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0597-0148-66",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (0597-0148-66) ",
      "NDC11Code": "00597-0148-66",
      "ProductNDC": "0597-0148",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Jentadueto",
      "NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120213",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201281",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "2.5; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120213",
      "EndMarketingDatePackage": "20250228",
      "SamplePackage": "N",
      "IndicationAndUsage": "JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "JENTADUETO tablets for oral use contain: linagliptin and metformin HCl."
    },
    {
      "NDCCode": "0597-0159-66",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0597-0159-66)  / 14 TABLET in 1 BOTTLE",
      "NDC11Code": "00597-0159-66",
      "ProductNDC": "0597-0159",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Synjardy",
      "NonProprietaryName": "Empagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150826",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206111",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "5; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20150912",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0597-0168-66",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0597-0168-66)  / 14 TABLET in 1 BOTTLE",
      "NDC11Code": "00597-0168-66",
      "ProductNDC": "0597-0168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Synjardy",
      "NonProprietaryName": "Empagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150826",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206111",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "12.5; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150912",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "SYNJARDY. SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl) immediate-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR. SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl extended-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin. Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Cardiovascular (CV) death in adults with established CV disease. (1), 2 CV death and hospitalization for heart failure in adults with heart failure. (1), 3 Sustained decline in eGFR, end-stage kidney disease, CV death, and hospitalization in adults with chronic kidney disease at risk of progression. (1).",
      "Description": "SYNJARDY and SYNJARDY XR tablets for oral use contain: empagliflozin and metformin HCl."
    },
    {
      "NDCCode": "0597-0175-66",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0597-0175-66)  / 14 TABLET in 1 BOTTLE",
      "NDC11Code": "00597-0175-66",
      "ProductNDC": "0597-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Synjardy",
      "NonProprietaryName": "Empagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150826",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206111",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "5; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20150912",
      "EndMarketingDatePackage": "20240331",
      "SamplePackage": "N",
      "IndicationAndUsage": "SYNJARDY. SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR. SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin. Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Cardiovascular death in adults with established cardiovascular disease. (1), 2 Cardiovascular death and hospitalization for heart failure in adults with heart failure. (1).",
      "Description": "SYNJARDY and SYNJARDY XR tablets for oral use contain: empagliflozin and metformin HCl."
    },
    {
      "NDCCode": "0597-0180-66",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0597-0180-66)  / 14 TABLET in 1 BOTTLE",
      "NDC11Code": "00597-0180-66",
      "ProductNDC": "0597-0180",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Synjardy",
      "NonProprietaryName": "Empagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150826",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206111",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "12.5; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20150912",
      "EndMarketingDatePackage": "20231130",
      "SamplePackage": "N",
      "IndicationAndUsage": "SYNJARDY. SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR. SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin. Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Cardiovascular death in adults with established cardiovascular disease. (1), 2 Cardiovascular death and hospitalization for heart failure in adults with heart failure. (1).",
      "Description": "SYNJARDY and SYNJARDY XR tablets for oral use contain: empagliflozin and metformin HCl."
    },
    {
      "NDCCode": "50474-597-66",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-597-66) ",
      "NDC11Code": "50474-0597-66",
      "ProductNDC": "50474-597",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Keppra",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000424",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021035",
      "LabelerName": "UCB, Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20000424",
      "SamplePackage": "N",
      "IndicationAndUsage": "KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1). KEPPRA is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .",
      "Description": "KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). KEPPRA tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red. KEPPRA oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor."
    },
    {
      "NDCCode": "0054-0545-18",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (0054-0545-18)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00054-0545-18",
      "ProductNDC": "0054-0545",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140228",
      "EndMarketingDate": "20221231",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021162",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; TELMISARTAN",
      "StrengthNumber": "12.5; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140228",
      "EndMarketingDatePackage": "20221231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0545-05",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0078-0545-05) ",
      "NDC11Code": "00078-0545-05",
      "ProductNDC": "0078-0545",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stalevo",
      "NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080926",
      "EndMarketingDate": "20211231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021485",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
      "StrengthNumber": "31.25; 125; 200",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20080926",
      "EndMarketingDatePackage": "20211231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0220-0545-41",
      "PackageDescription": "30 [hp_C] in 1 TUBE (0220-0545-41) ",
      "NDC11Code": "00220-0545-41",
      "ProductNDC": "0220-0545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arsenicum Sulphuratum Flavum",
      "NonProprietaryName": "Arsenic Trisulfide",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19830303",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Boiron",
      "SubstanceName": "ARSENIC TRISULFIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/30[hp_C]",
      "Status": "Active",
      "LastUpdate": "2024-04-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19830303",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: See symptoms on front panel. Relieves dry cough aggravated by cold *."
    },
    {
      "NDCCode": "0363-0545-26",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0363-0545-26)  > 120 mL in 1 BOTTLE",
      "NDC11Code": "00363-0545-26",
      "ProductNDC": "0363-0545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wal Zyr",
      "ProprietaryNameSuffix": "Childrens",
      "NonProprietaryName": "Cetirizine Hcl",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150811",
      "EndMarketingDate": "20191231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204226",
      "LabelerName": "Walgreen Company",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150811",
      "EndMarketingDatePackage": "20191231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0363-0545-34",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0363-0545-34)  > 240 mL in 1 BOTTLE",
      "NDC11Code": "00363-0545-34",
      "ProductNDC": "0363-0545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wal Zyr",
      "ProprietaryNameSuffix": "Childrens",
      "NonProprietaryName": "Cetirizine Hcl",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150811",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204226",
      "LabelerName": "Walgreen Company",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-18",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0406-0545-05",
      "PackageDescription": "100000 g in 1 DRUM (0406-0545-05) ",
      "NDC11Code": "00406-0545-05",
      "ProductNDC": "0406-0545",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levorphanol Tartrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130401",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "LEVORPHANOL TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2025-09-18",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-APR-13",
      "EndMarketingDatePackage": "01-MAR-31"
    },
    {
      "NDCCode": "0406-0545-40",
      "PackageDescription": "500 g in 1 BOTTLE, GLASS (0406-0545-40) ",
      "NDC11Code": "00406-0545-40",
      "ProductNDC": "0406-0545",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levorphanol Tartrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130401",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "LEVORPHANOL TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2025-09-18",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-JAN-25"
    },
    {
      "NDCCode": "0406-0545-41",
      "PackageDescription": "6000 g in 1 PAIL (0406-0545-41) ",
      "NDC11Code": "00406-0545-41",
      "ProductNDC": "0406-0545",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levorphanol Tartrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130401",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "LEVORPHANOL TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2025-09-18",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-JAN-25"
    },
    {
      "NDCCode": "0406-0545-42",
      "PackageDescription": "15000 g in 1 DRUM (0406-0545-42) ",
      "NDC11Code": "00406-0545-42",
      "ProductNDC": "0406-0545",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levorphanol Tartrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130401",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "LEVORPHANOL TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2025-09-18",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-JAN-25"
    },
    {
      "NDCCode": "10544-545-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (10544-545-30)",
      "NDC11Code": "10544-0545-30",
      "ProductNDC": "10544-545",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Allopurinol",
      "NonProprietaryName": "Allopurinol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090637",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "ALLOPURINOL",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol tablets are indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). , 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. , 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks. .",
      "Description": "Allopurinol has the following structural formula:. C5H4N4O                M.W. = 136.11. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d] pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. Each scored white to off-white tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate, povidone and stearic acid. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate , FD & C yellow no. 6, povidone and stearic acid."
    },
    {
      "NDCCode": "10544-545-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (10544-545-90)",
      "NDC11Code": "10544-0545-90",
      "ProductNDC": "10544-545",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Allopurinol",
      "NonProprietaryName": "Allopurinol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090637",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "ALLOPURINOL",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol tablets are indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). , 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. , 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks. .",
      "Description": "Allopurinol has the following structural formula:. C5H4N4O                M.W. = 136.11. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d] pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. Each scored white to off-white tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate, povidone and stearic acid. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate , FD & C yellow no. 6, povidone and stearic acid."
    },
    {
      "NDCCode": "11673-545-16",
      "PackageDescription": ".06 L in 1 BOTTLE, PLASTIC (11673-545-16) ",
      "NDC11Code": "11673-0545-16",
      "ProductNDC": "11673-545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Instant Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090109",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Target Corp.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".62",
      "StrengthUnit": "kg/100L",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090109",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11673-545-24",
      "PackageDescription": ".24 L in 1 BOTTLE, PLASTIC (11673-545-24) ",
      "NDC11Code": "11673-0545-24",
      "ProductNDC": "11673-545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Instant Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090109",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Target Corp.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".62",
      "StrengthUnit": "kg/100L",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090109",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11673-545-45",
      "PackageDescription": ".94 L in 1 BOTTLE, PLASTIC (11673-545-45) ",
      "NDC11Code": "11673-0545-45",
      "ProductNDC": "11673-545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Instant Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090109",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Target Corp.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".62",
      "StrengthUnit": "kg/100L",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090109",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "12658-0545-1",
      "PackageDescription": "5 kg in 1 DRUM (12658-0545-1)",
      "NDC11Code": "12658-0545-01",
      "ProductNDC": "12658-0545",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Acetazolamide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19820101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "ZAKLADY FARMACEUTYCZNE POLPHARMA S A",
      "SubstanceName": "ACETAZOLAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "kg/5kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "13537-545-02",
      "PackageDescription": "1 TUBE in 1 BOX (13537-545-02)  > 4 g in 1 TUBE (13537-545-01)",
      "NDC11Code": "13537-0545-02",
      "ProductNDC": "13537-545",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Couleur Luxe Amplifier Xp",
      "ProprietaryNameSuffix": "Amplifying Spf 15 - Rose Femme",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130527",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD.",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
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      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    }
  ]
}
                    

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<NDCList>
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    <NDCCode>0597-0545-66</NDCCode>
    <PackageDescription>6 KIT in 1 CARTON (0597-0545-66)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (0597-0540-10)  / .8 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET</PackageDescription>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab-adbm</ProprietaryName>
    <NonProprietaryName>Adalimumab-adbm</NonProprietaryName>
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    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761058</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-22</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Plaque Psoriasis (Ps) (1.7): 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., 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
    <Description>Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody 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. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.</Description>
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    <NDCCode>0597-0545-22</NDCCode>
    <PackageDescription>2 KIT in 1 CARTON (0597-0545-22)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (0597-0540-10)  / .8 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET</PackageDescription>
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    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761058</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-adbm 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).</IndicationAndUsage>
    <Description>Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody 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. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.</Description>
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    <PackageDescription>4 KIT in 1 CARTON (0597-0545-44)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (0597-0540-10)  / .8 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET</PackageDescription>
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    <DosageFormName>KIT</DosageFormName>
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    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761058</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-01</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <StartMarketingDatePackage>20231001</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): 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 RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Plaque Psoriasis (Ps) (1.7): 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., 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
    <Description>Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody 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. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.</Description>
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    <NDCCode>62756-545-66</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (62756-545-66)  &gt; 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>62756-0545-66</NDC11Code>
    <ProductNDC>62756-545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091567</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
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    <NDC11Code>63824-0545-66</NDC11Code>
    <ProductNDC>63824-545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucinex Fast-max</ProprietaryName>
    <ProprietaryNameSuffix>Congestion And Headache Clear And Cool</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Reckitt Benckiser LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>650; 400; 10</StrengthNumber>
    <StrengthUnit>mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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    <NDCCode>0597-0121-66</NDCCode>
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    <ProprietaryName>Maximum Strength Zantac</ProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061221</StartMarketingDate>
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    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021698</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20061221</StartMarketingDatePackage>
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    <SamplePackage>N</SamplePackage>
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    <ProductNDC>0597-0146</ProductNDC>
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    <ProprietaryName>Jentadueto</ProprietaryName>
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    <StartMarketingDate>20120213</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201281</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LINAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
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    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
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    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120213</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JENTADUETO tablets for oral use contain: linagliptin and metformin HCl.</Description>
  </NDC>
  <NDC>
    <NDCCode>0597-0147-66</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (0597-0147-66) </PackageDescription>
    <NDC11Code>00597-0147-66</NDC11Code>
    <ProductNDC>0597-0147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Jentadueto</ProprietaryName>
    <NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120213</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201281</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LINAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5; 850</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0597-0148-66</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (0597-0148-66) </PackageDescription>
    <NDC11Code>00597-0148-66</NDC11Code>
    <ProductNDC>0597-0148</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Jentadueto</ProprietaryName>
    <NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120213</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201281</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LINAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5; 1000</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120213</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JENTADUETO tablets for oral use contain: linagliptin and metformin HCl.</Description>
  </NDC>
  <NDC>
    <NDCCode>0597-0159-66</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0597-0159-66)  / 14 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>00597-0159-66</NDC11Code>
    <ProductNDC>0597-0159</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Synjardy</ProprietaryName>
    <NonProprietaryName>Empagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150826</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206111</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0597-0168-66</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0597-0168-66)  / 14 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>00597-0168-66</NDC11Code>
    <ProductNDC>0597-0168</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Synjardy</ProprietaryName>
    <NonProprietaryName>Empagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150826</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206111</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5; 1000</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150912</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SYNJARDY. SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl) immediate-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR. SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl extended-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin. Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Cardiovascular (CV) death in adults with established CV disease. (1), 2 CV death and hospitalization for heart failure in adults with heart failure. (1), 3 Sustained decline in eGFR, end-stage kidney disease, CV death, and hospitalization in adults with chronic kidney disease at risk of progression. (1).</IndicationAndUsage>
    <Description>SYNJARDY and SYNJARDY XR tablets for oral use contain: empagliflozin and metformin HCl.</Description>
  </NDC>
  <NDC>
    <NDCCode>0597-0175-66</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0597-0175-66)  / 14 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>00597-0175-66</NDC11Code>
    <ProductNDC>0597-0175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Synjardy</ProprietaryName>
    <NonProprietaryName>Empagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150826</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206111</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 1000</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150912</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SYNJARDY. SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR. SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin. Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Cardiovascular death in adults with established cardiovascular disease. (1), 2 Cardiovascular death and hospitalization for heart failure in adults with heart failure. (1).</IndicationAndUsage>
    <Description>SYNJARDY and SYNJARDY XR tablets for oral use contain: empagliflozin and metformin HCl.</Description>
  </NDC>
  <NDC>
    <NDCCode>0597-0180-66</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0597-0180-66)  / 14 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>00597-0180-66</NDC11Code>
    <ProductNDC>0597-0180</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Synjardy</ProprietaryName>
    <NonProprietaryName>Empagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150826</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206111</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150912</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SYNJARDY. SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR. SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin. Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Cardiovascular death in adults with established cardiovascular disease. (1), 2 Cardiovascular death and hospitalization for heart failure in adults with heart failure. (1).</IndicationAndUsage>
    <Description>SYNJARDY and SYNJARDY XR tablets for oral use contain: empagliflozin and metformin HCl.</Description>
  </NDC>
  <NDC>
    <NDCCode>50474-597-66</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-597-66) </PackageDescription>
    <NDC11Code>50474-0597-66</NDC11Code>
    <ProductNDC>50474-597</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Keppra</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000424</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021035</ApplicationNumber>
    <LabelerName>UCB, Inc.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1). KEPPRA is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .</IndicationAndUsage>
    <Description>KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). KEPPRA tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&amp;C Blue #2/indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: FD&amp;C yellow #6/sunset yellow FCF aluminum lake, iron oxide red. KEPPRA oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0545-18</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0054-0545-18)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00054-0545-18</NDC11Code>
    <ProductNDC>0054-0545</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140228</StartMarketingDate>
    <EndMarketingDate>20221231</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021162</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE; TELMISARTAN</SubstanceName>
    <StrengthNumber>12.5; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140228</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0545-05</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0078-0545-05) </PackageDescription>
    <NDC11Code>00078-0545-05</NDC11Code>
    <ProductNDC>0078-0545</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stalevo</ProprietaryName>
    <NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080926</StartMarketingDate>
    <EndMarketingDate>20211231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021485</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
    <StrengthNumber>31.25; 125; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20080926</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0220-0545-41</NDCCode>
    <PackageDescription>30 [hp_C] in 1 TUBE (0220-0545-41) </PackageDescription>
    <NDC11Code>00220-0545-41</NDC11Code>
    <ProductNDC>0220-0545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arsenicum Sulphuratum Flavum</ProprietaryName>
    <NonProprietaryName>Arsenic Trisulfide</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19830303</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Boiron</LabelerName>
    <SubstanceName>ARSENIC TRISULFIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/30[hp_C]</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-04-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19830303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: See symptoms on front panel. Relieves dry cough aggravated by cold *.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0363-0545-26</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0363-0545-26)  &gt; 120 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00363-0545-26</NDC11Code>
    <ProductNDC>0363-0545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wal Zyr</ProprietaryName>
    <ProprietaryNameSuffix>Childrens</ProprietaryNameSuffix>
    <NonProprietaryName>Cetirizine Hcl</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150811</StartMarketingDate>
    <EndMarketingDate>20191231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204226</ApplicationNumber>
    <LabelerName>Walgreen Company</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150811</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0363-0545-34</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0363-0545-34)  &gt; 240 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00363-0545-34</NDC11Code>
    <ProductNDC>0363-0545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wal Zyr</ProprietaryName>
    <ProprietaryNameSuffix>Childrens</ProprietaryNameSuffix>
    <NonProprietaryName>Cetirizine Hcl</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150811</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204226</ApplicationNumber>
    <LabelerName>Walgreen Company</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-18</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0406-0545-05</NDCCode>
    <PackageDescription>100000 g in 1 DRUM (0406-0545-05) </PackageDescription>
    <NDC11Code>00406-0545-05</NDC11Code>
    <ProductNDC>0406-0545</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levorphanol Tartrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130401</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>LEVORPHANOL TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2025-09-18</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-APR-13</StartMarketingDatePackage>
    <EndMarketingDatePackage>01-MAR-31</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0406-0545-40</NDCCode>
    <PackageDescription>500 g in 1 BOTTLE, GLASS (0406-0545-40) </PackageDescription>
    <NDC11Code>00406-0545-40</NDC11Code>
    <ProductNDC>0406-0545</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levorphanol Tartrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130401</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>LEVORPHANOL TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2025-09-18</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0406-0545-41</NDCCode>
    <PackageDescription>6000 g in 1 PAIL (0406-0545-41) </PackageDescription>
    <NDC11Code>00406-0545-41</NDC11Code>
    <ProductNDC>0406-0545</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levorphanol Tartrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130401</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>LEVORPHANOL TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2025-09-18</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0406-0545-42</NDCCode>
    <PackageDescription>15000 g in 1 DRUM (0406-0545-42) </PackageDescription>
    <NDC11Code>00406-0545-42</NDC11Code>
    <ProductNDC>0406-0545</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levorphanol Tartrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130401</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>LEVORPHANOL TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2025-09-18</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10544-545-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (10544-545-30)</PackageDescription>
    <NDC11Code>10544-0545-30</NDC11Code>
    <ProductNDC>10544-545</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Allopurinol</ProprietaryName>
    <NonProprietaryName>Allopurinol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090637</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>ALLOPURINOL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol tablets are indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). , 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. , 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks. .</IndicationAndUsage>
    <Description>Allopurinol has the following structural formula:. C5H4N4O                M.W. = 136.11. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d] pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. Each scored white to off-white tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate, povidone and stearic acid. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate , FD &amp; C yellow no. 6, povidone and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-545-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (10544-545-90)</PackageDescription>
    <NDC11Code>10544-0545-90</NDC11Code>
    <ProductNDC>10544-545</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Allopurinol</ProprietaryName>
    <NonProprietaryName>Allopurinol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090637</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>ALLOPURINOL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol tablets are indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). , 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. , 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks. .</IndicationAndUsage>
    <Description>Allopurinol has the following structural formula:. C5H4N4O                M.W. = 136.11. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d] pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. Each scored white to off-white tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate, povidone and stearic acid. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate , FD &amp; C yellow no. 6, povidone and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>11673-545-16</NDCCode>
    <PackageDescription>.06 L in 1 BOTTLE, PLASTIC (11673-545-16) </PackageDescription>
    <NDC11Code>11673-0545-16</NDC11Code>
    <ProductNDC>11673-545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090109</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Target Corp.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.62</StrengthNumber>
    <StrengthUnit>kg/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11673-545-24</NDCCode>
    <PackageDescription>.24 L in 1 BOTTLE, PLASTIC (11673-545-24) </PackageDescription>
    <NDC11Code>11673-0545-24</NDC11Code>
    <ProductNDC>11673-545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090109</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Target Corp.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.62</StrengthNumber>
    <StrengthUnit>kg/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11673-545-45</NDCCode>
    <PackageDescription>.94 L in 1 BOTTLE, PLASTIC (11673-545-45) </PackageDescription>
    <NDC11Code>11673-0545-45</NDC11Code>
    <ProductNDC>11673-545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20090109</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Target Corp.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.62</StrengthNumber>
    <StrengthUnit>kg/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>12658-0545-1</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (12658-0545-1)</PackageDescription>
    <NDC11Code>12658-0545-01</NDC11Code>
    <ProductNDC>12658-0545</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Acetazolamide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19820101</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>ZAKLADY FARMACEUTYCZNE POLPHARMA S A</LabelerName>
    <SubstanceName>ACETAZOLAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>kg/5kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>13537-545-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-545-02)  &gt; 4 g in 1 TUBE (13537-545-01)</PackageDescription>
    <NDC11Code>13537-0545-02</NDC11Code>
    <ProductNDC>13537-545</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Couleur Luxe Amplifier Xp</ProprietaryName>
    <ProprietaryNameSuffix>Amplifying Spf 15 - Rose Femme</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130527</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD.</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.047; .009</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0597-0545-66</NDCCode><ProprietaryName>Adalimumab-adbm</ProprietaryName><NonProprietaryName>Adalimumab-adbm</NonProprietaryName></NDC><NDC><NDCCode>0597-0545-22</NDCCode><ProprietaryName>Adalimumab-adbm</ProprietaryName><NonProprietaryName>Adalimumab-adbm</NonProprietaryName></NDC><NDC><NDCCode>0597-0545-44</NDCCode><ProprietaryName>Adalimumab-adbm</ProprietaryName><NonProprietaryName>Adalimumab-adbm</NonProprietaryName></NDC><NDC><NDCCode>62756-545-66</NDCCode><ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName><NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63824-545-66</NDCCode><ProprietaryName>Mucinex Fast-max</ProprietaryName><NonProprietaryName>Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0597-0121-66</NDCCode><ProprietaryName>Maximum Strength Zantac</ProprietaryName><NonProprietaryName>Ranitidine</NonProprietaryName></NDC><NDC><NDCCode>0597-0146-66</NDCCode><ProprietaryName>Jentadueto</ProprietaryName><NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0597-0147-66</NDCCode><ProprietaryName>Jentadueto</ProprietaryName><NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0597-0148-66</NDCCode><ProprietaryName>Jentadueto</ProprietaryName><NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0597-0159-66</NDCCode><ProprietaryName>Synjardy</ProprietaryName><NonProprietaryName>Empagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0597-0168-66</NDCCode><ProprietaryName>Synjardy</ProprietaryName><NonProprietaryName>Empagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0597-0175-66</NDCCode><ProprietaryName>Synjardy</ProprietaryName><NonProprietaryName>Empagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0597-0180-66</NDCCode><ProprietaryName>Synjardy</ProprietaryName><NonProprietaryName>Empagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50474-597-66</NDCCode><ProprietaryName>Keppra</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>0054-0545-18</NDCCode><ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0078-0545-05</NDCCode><ProprietaryName>Stalevo</ProprietaryName><NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName></NDC><NDC><NDCCode>0220-0545-41</NDCCode><ProprietaryName>Arsenicum Sulphuratum Flavum</ProprietaryName><NonProprietaryName>Arsenic Trisulfide</NonProprietaryName></NDC><NDC><NDCCode>0363-0545-26</NDCCode><ProprietaryName>Wal Zyr</ProprietaryName><NonProprietaryName>Cetirizine Hcl</NonProprietaryName></NDC><NDC><NDCCode>0363-0545-34</NDCCode><ProprietaryName>Wal Zyr</ProprietaryName><NonProprietaryName>Cetirizine Hcl</NonProprietaryName></NDC><NDC><NDCCode>0406-0545-05</NDCCode><NonProprietaryName>Levorphanol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0406-0545-40</NDCCode><NonProprietaryName>Levorphanol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0406-0545-41</NDCCode><NonProprietaryName>Levorphanol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0406-0545-42</NDCCode><NonProprietaryName>Levorphanol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>10544-545-30</NDCCode><ProprietaryName>Allopurinol</ProprietaryName><NonProprietaryName>Allopurinol</NonProprietaryName></NDC><NDC><NDCCode>10544-545-90</NDCCode><ProprietaryName>Allopurinol</ProprietaryName><NonProprietaryName>Allopurinol</NonProprietaryName></NDC><NDC><NDCCode>11673-545-16</NDCCode><ProprietaryName>Instant Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>11673-545-24</NDCCode><ProprietaryName>Instant Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>11673-545-45</NDCCode><ProprietaryName>Instant Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>12658-0545-1</NDCCode><NonProprietaryName>Acetazolamide</NonProprietaryName></NDC><NDC><NDCCode>13537-545-02</NDCCode><ProprietaryName>Lbel Couleur Luxe Amplifier Xp</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
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    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
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}
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