RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (29 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "64764-140-05",
      "PackageDescription": "1 KIT in 1 CARTON (64764-140-05)  *  500 [iU] in 1 VIAL, SINGLE-DOSE (64764-130-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) ",
      "NDC11Code": "64764-0140-05",
      "ProductNDC": "64764-140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adzynma",
      "NonProprietaryName": "Apadamtase Alfa",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231109",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125795",
      "LabelerName": "TAKEDA PHARMACEUTICALS AMERICA, INC.",
      "Status": "Active",
      "LastUpdate": "2026-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231109",
      "SamplePackage": "N",
      "IndicationAndUsage": "ADZYNMA is indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) [see Use in Specific Populations (8.4), Clinical Studies (14)].",
      "Description": "ADZYNMA is a purified bivariant human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) expressed in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology (a mixture of Native rADAMTS13 Q23 and Variant rADAMTS13 R23 with a controlled range of the two variants ratio). ADZYNMA is produced and formulated without the addition of any exogenous raw materials of human or animal origin in the cell culture, purification, or formulation of the final product. The purification process for rADAMTS13 does not include use of a monoclonal antibody reagent. To enhance viral safety, the production process also incorporates two dedicated viral clearance steps – a solvent/detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. Recombinant ADAMTS13 has a molecular weight of approximately 172 kDa. Proteins that may be present in the final product, other than rADAMTS13, are trace quantities of host cell (CHO) proteins. ADZYNMA (rADAMTS13) is a sterile, nonpyrogenic, preservative free, white powder supplied in single-dose vials for IV use after reconstitution. Each single-dose vial contains nominally 500 IU or 1500 IU of rADAMTS13, sodium chloride (9.4 mg), calcium chloride dihydrate (1.6 mg), L-histidine (16.7 mg), mannitol (161.4 mg), sucrose (53.8 mg), and polysorbate 80 (2.7 mg). Each vial of ADZYNMA is labeled with the specific number of units of ADAMTS13 potency expressed in IU as measured with a fluorescence resonance energy transfer (FRET) assay using a synthetic 73-amino-acid peptide (FRETS-VWF73). The potency assignment employs an ADAMTS13 concentrate standard that is referenced to a WHO (World Health Organization) international standard for ADAMTS13 concentrates and is evaluated by appropriate methodology to ensure accuracy of the results. After reconstitution with 5 mL of Sterile Water for Injection, USP, the 500 IU and the 1500 IU vials result in a nominal potency of 100 IU/mL and 300 IU/mL, respectively. All dosage strengths yield a clear, colorless solution, free from particles with a pH of approximately 7.0."
    },
    {
      "NDCCode": "0944-4177-05",
      "PackageDescription": "1 KIT in 1 CARTON (0944-4177-05)  *  5 mL in 1 VIAL, GLASS (0944-4176-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) ",
      "NDC11Code": "00944-4177-05",
      "ProductNDC": "0944-4177",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Ceprotin",
      "NonProprietaryName": "Protein C Concentrate Human",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20100809",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125234",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100809",
      "SamplePackage": "N",
      "IndicationAndUsage": "CEPROTIN®, Protein C Concentrate (Human), is an anticoagulant indicated for neonates, pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.",
      "Description": "CEPROTIN [Protein C Concentrate (Human)] is manufactured from human plasma purified by a combination of filtration and chromatographic procedures, including a column of immobilized mouse monoclonal antibodies on gel beads [See WARNINGS AND PRECAUTIONS: Transmissible Infectious Agents (5.2)]. The manufacturing process for CEPROTIN includes processing steps designed to reduce the risk of viral transmission. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: Human Immunodeficiency Virus Type 1 (HIV-1), Bovine Viral Diarrhea Virus (BVDV ), Tick-Borne Encephalitis Virus (TBEV), Pseudorabies Virus (PRV), Hepatitis A Virus (HAV) and Mice Minute Virus (MMV). Virus reduction steps consist of detergent treatment (Polysorbate 80, P80), heat inactivation (Vapor Heating) and immunoaffinity chromatography (IAX). Virus clearance studies for CEPROTIN have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log10 virus reduction factors per virus and manufacturing step is presented in Table 2."
    },
    {
      "NDCCode": "64764-119-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-05) ",
      "NDC11Code": "64764-0119-05",
      "ProductNDC": "64764-119",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Colcrys",
      "NonProprietaryName": "Colchicine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022352",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "COLCHICINE",
      "StrengthNumber": ".6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64764-121-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64764-121-05) ",
      "NDC11Code": "64764-0121-05",
      "ProductNDC": "64764-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseni",
      "NonProprietaryName": "Alogliptin And Pioglitazone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022426",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "12.5; 15",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20130125",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64764-123-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64764-123-05) ",
      "NDC11Code": "64764-0123-05",
      "ProductNDC": "64764-123",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseni",
      "NonProprietaryName": "Alogliptin And Pioglitazone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022426",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "12.5; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130125",
      "SamplePackage": "N",
      "IndicationAndUsage": "OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone."
    },
    {
      "NDCCode": "64764-124-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64764-124-05) ",
      "NDC11Code": "64764-0124-05",
      "ProductNDC": "64764-124",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseni",
      "NonProprietaryName": "Alogliptin And Pioglitazone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022426",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "12.5; 45",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20130125",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64764-145-05",
      "PackageDescription": "1 KIT in 1 CARTON (64764-145-05)  *  1500 [iU] in 1 VIAL, SINGLE-DOSE (64764-135-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) ",
      "NDC11Code": "64764-0145-05",
      "ProductNDC": "64764-145",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adzynma",
      "NonProprietaryName": "Apadamtase Alfa",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231109",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125795",
      "LabelerName": "TAKEDA PHARMACEUTICALS AMERICA, INC.",
      "Status": "Active",
      "LastUpdate": "2026-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231109",
      "SamplePackage": "N",
      "IndicationAndUsage": "ADZYNMA is indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) [see Use in Specific Populations (8.4), Clinical Studies (14)].",
      "Description": "ADZYNMA is a purified bivariant human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) expressed in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology (a mixture of Native rADAMTS13 Q23 and Variant rADAMTS13 R23 with a controlled range of the two variants ratio). ADZYNMA is produced and formulated without the addition of any exogenous raw materials of human or animal origin in the cell culture, purification, or formulation of the final product. The purification process for rADAMTS13 does not include use of a monoclonal antibody reagent. To enhance viral safety, the production process also incorporates two dedicated viral clearance steps – a solvent/detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. Recombinant ADAMTS13 has a molecular weight of approximately 172 kDa. Proteins that may be present in the final product, other than rADAMTS13, are trace quantities of host cell (CHO) proteins. ADZYNMA (rADAMTS13) is a sterile, nonpyrogenic, preservative free, white powder supplied in single-dose vials for IV use after reconstitution. Each single-dose vial contains nominally 500 IU or 1500 IU of rADAMTS13, sodium chloride (9.4 mg), calcium chloride dihydrate (1.6 mg), L-histidine (16.7 mg), mannitol (161.4 mg), sucrose (53.8 mg), and polysorbate 80 (2.7 mg). Each vial of ADZYNMA is labeled with the specific number of units of ADAMTS13 potency expressed in IU as measured with a fluorescence resonance energy transfer (FRET) assay using a synthetic 73-amino-acid peptide (FRETS-VWF73). The potency assignment employs an ADAMTS13 concentrate standard that is referenced to a WHO (World Health Organization) international standard for ADAMTS13 concentrates and is evaluated by appropriate methodology to ensure accuracy of the results. After reconstitution with 5 mL of Sterile Water for Injection, USP, the 500 IU and the 1500 IU vials result in a nominal potency of 100 IU/mL and 300 IU/mL, respectively. All dosage strengths yield a clear, colorless solution, free from particles with a pH of approximately 7.0."
    },
    {
      "NDCCode": "64764-151-05",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64764-151-05) ",
      "NDC11Code": "64764-0151-05",
      "ProductNDC": "64764-151",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Actos",
      "NonProprietaryName": "Pioglitazone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19990715",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021073",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19990715",
      "SamplePackage": "N",
      "IndicationAndUsage": "Monotherapy and Combination Therapy. ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
      "Description": "ACTOS tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF."
    },
    {
      "NDCCode": "64764-251-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64764-251-05) ",
      "NDC11Code": "64764-0251-05",
      "ProductNDC": "64764-251",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseni",
      "NonProprietaryName": "Alogliptin And Pioglitazone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022426",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "25; 15",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130125",
      "SamplePackage": "N",
      "IndicationAndUsage": "OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone."
    },
    {
      "NDCCode": "64764-253-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64764-253-05) ",
      "NDC11Code": "64764-0253-05",
      "ProductNDC": "64764-253",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseni",
      "NonProprietaryName": "Alogliptin And Pioglitazone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022426",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "25; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130125",
      "SamplePackage": "N",
      "IndicationAndUsage": "OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone."
    },
    {
      "NDCCode": "64764-254-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64764-254-05) ",
      "NDC11Code": "64764-0254-05",
      "ProductNDC": "64764-254",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseni",
      "NonProprietaryName": "Alogliptin And Pioglitazone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022426",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "25; 45",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130125",
      "SamplePackage": "N",
      "IndicationAndUsage": "OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone."
    },
    {
      "NDCCode": "64764-541-05",
      "PackageDescription": "5 BLISTER PACK in 1 TRAY (64764-541-05)  > 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "64764-0541-05",
      "ProductNDC": "64764-541",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevacid",
      "NonProprietaryName": "Lansoprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950510",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020406",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "LANSOPRAZOLE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19950510",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64764-543-05",
      "PackageDescription": "5 BLISTER PACK in 1 TRAY (64764-543-05)  / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "64764-0543-05",
      "ProductNDC": "64764-543",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevacid Solutab",
      "NonProprietaryName": "Lansoprazole",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020830",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021428",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "LANSOPRAZOLE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020830",
      "SamplePackage": "N",
      "IndicationAndUsage": "PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
      "Description": "The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartamePhenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet., glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide."
    },
    {
      "NDCCode": "64764-544-05",
      "PackageDescription": "5 BLISTER PACK in 1 TRAY (64764-544-05)  / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "64764-0544-05",
      "ProductNDC": "64764-544",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevacid Solutab",
      "NonProprietaryName": "Lansoprazole",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020830",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021428",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "SubstanceName": "LANSOPRAZOLE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020830",
      "SamplePackage": "N",
      "IndicationAndUsage": "PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
      "Description": "The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartamePhenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet., glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide."
    },
    {
      "NDCCode": "0135-0246-05",
      "PackageDescription": "140 TABLET, CHEWABLE in 1 BOTTLE (0135-0246-05) ",
      "NDC11Code": "00135-0246-05",
      "ProductNDC": "0135-0246",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tums",
      "ProprietaryNameSuffix": "Smoothies",
      "NonProprietaryName": "Calcium Carbonate",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100324",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "Haleon US Holdings LLC",
      "SubstanceName": "CALCIUM CARBONATE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140810",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
    },
    {
      "NDCCode": "0135-0456-05",
      "PackageDescription": "140 TABLET, CHEWABLE in 1 BOTTLE (0135-0456-05) ",
      "NDC11Code": "00135-0456-05",
      "ProductNDC": "0135-0456",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tums",
      "ProprietaryNameSuffix": "Smoothies",
      "NonProprietaryName": "Calcium Carbonate",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100324",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "Haleon US Holdings LLC",
      "SubstanceName": "CALCIUM CARBONATE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20100324",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
    },
    {
      "NDCCode": "0135-0542-01",
      "PackageDescription": "1 KIT in 1 CARTON (0135-0542-01)  *  140 TABLET, CHEWABLE in 1 BOTTLE (0135-0456-05)  *  1 BOTTLE in 1 CARTON (0135-0522-02)  > 25 TABLET, CHEWABLE in 1 BOTTLE",
      "NDC11Code": "00135-0542-01",
      "ProductNDC": "0135-0542",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tums",
      "NonProprietaryName": "Calcium Carbonate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20120914",
      "EndMarketingDate": "20140228",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "GlaxoSmithKline Consumer Heathcare LP",
      "Status": "Deprecated",
      "LastUpdate": "2014-03-05"
    },
    {
      "NDCCode": "10631-278-05",
      "PackageDescription": "140 g in 1 BOTTLE, PLASTIC (10631-278-05)",
      "NDC11Code": "10631-0278-05",
      "ProductNDC": "10631-278",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Desquam-x Wash",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110426",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Ranbaxy Laboratories Inc.",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10631-279-05",
      "PackageDescription": "140 g in 1 BOTTLE, PLASTIC (10631-279-05)",
      "NDC11Code": "10631-0279-05",
      "ProductNDC": "10631-279",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Desquam-x Wash",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110426",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Ranbaxy Laboratories Inc.",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "12745-140-05",
      "PackageDescription": "208198 mL in 1 BOTTLE, PLASTIC (12745-140-05)",
      "NDC11Code": "12745-0140-05",
      "ProductNDC": "12745-140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tincture Green Soap",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19540615",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Medical Chemical Corporation",
      "SubstanceName": "ROSIN; POTASSIUM HYDROXIDE; ALCOHOL",
      "StrengthNumber": "2.47; 5.961; 24.93",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-14",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "13668-140-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (13668-140-05) ",
      "NDC11Code": "13668-0140-05",
      "ProductNDC": "13668-140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pioglitazonehydrochloride",
      "NonProprietaryName": "Pioglitazonehydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091298",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20130213",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "23155-140-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (23155-140-05)",
      "NDC11Code": "23155-0140-05",
      "ProductNDC": "23155-140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090620",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079237",
      "LabelerName": "Heritage Pharmaceuticals Inc",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "29300-140-05",
      "PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-140-05) ",
      "NDC11Code": "29300-0140-05",
      "ProductNDC": "29300-140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Divalproex Sodium",
      "NonProprietaryName": "Divalproex Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079163",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "DIVALPROEX SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20111001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
      "Description": "Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration.  Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
    },
    {
      "NDCCode": "42043-140-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (42043-140-05) ",
      "NDC11Code": "42043-0140-05",
      "ProductNDC": "42043-140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071212",
      "EndMarketingDate": "20200831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065248",
      "LabelerName": "OrchidPharma Inc",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20071212",
      "EndMarketingDatePackage": "20200531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "46144-140-05",
      "PackageDescription": "5 g in 1 BOTTLE, PLASTIC (46144-140-05)",
      "NDC11Code": "46144-0140-05",
      "ProductNDC": "46144-140",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Liothyronine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140408",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "API Solutions, Inc.",
      "SubstanceName": "LIOTHYRONINE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "49632-140-05",
      "PackageDescription": "1 BAG in 1 DRUM (49632-140-05)  / 1 kg in 1 BAG",
      "NDC11Code": "49632-0140-05",
      "ProductNDC": "49632-140",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Domiphen Bromide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230412",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "PMC Isochem",
      "SubstanceName": "DOMIPHEN BROMIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-05-10",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "12-APR-23"
    },
    {
      "NDCCode": "51660-140-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (51660-140-05) ",
      "NDC11Code": "51660-0140-05",
      "ProductNDC": "51660-140",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Valsartan",
      "NonProprietaryName": "Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140707",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077492",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "VALSARTAN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140707",
      "SamplePackage": "N",
      "IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3) .",
      "Description": "Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is:. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, soluble in methanol, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, ferric oxide black (in 160 mg and 320 mg strength), ferric oxide red (in 80 mg, 160 mg, and 320 mg strength), ferric oxide yellow (in 40 mg, 80 mg, and 320 mg strength), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, talc, and titanium dioxide. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "51769-140-05",
      "PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (51769-140-05)",
      "NDC11Code": "51769-0140-05",
      "ProductNDC": "51769-140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders",
      "ProprietaryNameSuffix": "Hair Loss Prevention",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "ALL NATURAL DYNAMICS",
      "SubstanceName": "PYRITHIONE ZINC",
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      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
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      "IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff. helps prevent hair loss."
    },
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      "NDCCode": "51879-140-51",
      "PackageDescription": "50 PACKET in 1 CARTON (51879-140-51)  > 14.17 g in 1 PACKET (51879-140-05)",
      "NDC11Code": "51879-0140-51",
      "ProductNDC": "51879-140",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tecnu Extreme",
      "NonProprietaryName": "Grindelia Robusta",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20041220",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Tec Laboratories, Inc.",
      "SubstanceName": "GRINDELIA HIRSUTULA FLOWERING TOP",
      "StrengthNumber": "3",
      "StrengthUnit": "[hp_X]/g",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-22"
    },
    {
      "NDCCode": "52389-670-05",
      "PackageDescription": "140 g in 1 TUBE (52389-670-05) ",
      "NDC11Code": "52389-0670-05",
      "ProductNDC": "52389-670",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Psoriasin In-shower",
      "ProprietaryNameSuffix": "Treatment",
      "NonProprietaryName": "Coal Tar",
      "DosageFormName": "LOTION/SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210303",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Kobayashi Healthcare International, Inc.",
      "SubstanceName": "COAL TAR",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210303",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the relief of symptoms of psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irriation of the skin. Helps prevent recurrence."
    }
  ]
}
                    

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  <NDC>
    <NDCCode>64764-140-05</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (64764-140-05)  *  500 [iU] in 1 VIAL, SINGLE-DOSE (64764-130-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
    <NDC11Code>64764-0140-05</NDC11Code>
    <ProductNDC>64764-140</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adzynma</ProprietaryName>
    <NonProprietaryName>Apadamtase Alfa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231109</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125795</ApplicationNumber>
    <LabelerName>TAKEDA PHARMACEUTICALS AMERICA, INC.</LabelerName>
    <Status>Active</Status>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <IndicationAndUsage>ADZYNMA is indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) [see Use in Specific Populations (8.4), Clinical Studies (14)].</IndicationAndUsage>
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  <NDC>
    <NDCCode>0944-4177-05</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0944-4177-05)  *  5 mL in 1 VIAL, GLASS (0944-4176-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
    <NDC11Code>00944-4177-05</NDC11Code>
    <ProductNDC>0944-4177</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Ceprotin</ProprietaryName>
    <NonProprietaryName>Protein C Concentrate Human</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20100809</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125234</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CEPROTIN®, Protein C Concentrate (Human), is an anticoagulant indicated for neonates, pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.</IndicationAndUsage>
    <Description>CEPROTIN [Protein C Concentrate (Human)] is manufactured from human plasma purified by a combination of filtration and chromatographic procedures, including a column of immobilized mouse monoclonal antibodies on gel beads [See WARNINGS AND PRECAUTIONS: Transmissible Infectious Agents (5.2)]. The manufacturing process for CEPROTIN includes processing steps designed to reduce the risk of viral transmission. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: Human Immunodeficiency Virus Type 1 (HIV-1), Bovine Viral Diarrhea Virus (BVDV ), Tick-Borne Encephalitis Virus (TBEV), Pseudorabies Virus (PRV), Hepatitis A Virus (HAV) and Mice Minute Virus (MMV). Virus reduction steps consist of detergent treatment (Polysorbate 80, P80), heat inactivation (Vapor Heating) and immunoaffinity chromatography (IAX). Virus clearance studies for CEPROTIN have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log10 virus reduction factors per virus and manufacturing step is presented in Table 2.</Description>
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    <NDCCode>64764-119-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-05) </PackageDescription>
    <NDC11Code>64764-0119-05</NDC11Code>
    <ProductNDC>64764-119</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Colcrys</ProprietaryName>
    <NonProprietaryName>Colchicine</NonProprietaryName>
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    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022352</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>COLCHICINE</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDCCode>64764-121-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64764-121-05) </PackageDescription>
    <NDC11Code>64764-0121-05</NDC11Code>
    <ProductNDC>64764-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseni</ProprietaryName>
    <NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022426</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5; 15</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDCCode>64764-123-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64764-123-05) </PackageDescription>
    <NDC11Code>64764-0123-05</NDC11Code>
    <ProductNDC>64764-123</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseni</ProprietaryName>
    <NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022426</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone.</Description>
  </NDC>
  <NDC>
    <NDCCode>64764-124-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64764-124-05) </PackageDescription>
    <NDC11Code>64764-0124-05</NDC11Code>
    <ProductNDC>64764-124</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseni</ProprietaryName>
    <NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022426</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5; 45</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>64764-145-05</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (64764-145-05)  *  1500 [iU] in 1 VIAL, SINGLE-DOSE (64764-135-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
    <NDC11Code>64764-0145-05</NDC11Code>
    <ProductNDC>64764-145</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adzynma</ProprietaryName>
    <NonProprietaryName>Apadamtase Alfa</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231109</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125795</ApplicationNumber>
    <LabelerName>TAKEDA PHARMACEUTICALS AMERICA, INC.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADZYNMA is indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) [see Use in Specific Populations (8.4), Clinical Studies (14)].</IndicationAndUsage>
    <Description>ADZYNMA is a purified bivariant human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) expressed in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology (a mixture of Native rADAMTS13 Q23 and Variant rADAMTS13 R23 with a controlled range of the two variants ratio). ADZYNMA is produced and formulated without the addition of any exogenous raw materials of human or animal origin in the cell culture, purification, or formulation of the final product. The purification process for rADAMTS13 does not include use of a monoclonal antibody reagent. To enhance viral safety, the production process also incorporates two dedicated viral clearance steps – a solvent/detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. Recombinant ADAMTS13 has a molecular weight of approximately 172 kDa. Proteins that may be present in the final product, other than rADAMTS13, are trace quantities of host cell (CHO) proteins. ADZYNMA (rADAMTS13) is a sterile, nonpyrogenic, preservative free, white powder supplied in single-dose vials for IV use after reconstitution. Each single-dose vial contains nominally 500 IU or 1500 IU of rADAMTS13, sodium chloride (9.4 mg), calcium chloride dihydrate (1.6 mg), L-histidine (16.7 mg), mannitol (161.4 mg), sucrose (53.8 mg), and polysorbate 80 (2.7 mg). Each vial of ADZYNMA is labeled with the specific number of units of ADAMTS13 potency expressed in IU as measured with a fluorescence resonance energy transfer (FRET) assay using a synthetic 73-amino-acid peptide (FRETS-VWF73). The potency assignment employs an ADAMTS13 concentrate standard that is referenced to a WHO (World Health Organization) international standard for ADAMTS13 concentrates and is evaluated by appropriate methodology to ensure accuracy of the results. After reconstitution with 5 mL of Sterile Water for Injection, USP, the 500 IU and the 1500 IU vials result in a nominal potency of 100 IU/mL and 300 IU/mL, respectively. All dosage strengths yield a clear, colorless solution, free from particles with a pH of approximately 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>64764-151-05</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (64764-151-05) </PackageDescription>
    <NDC11Code>64764-0151-05</NDC11Code>
    <ProductNDC>64764-151</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Actos</ProprietaryName>
    <NonProprietaryName>Pioglitazone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19990715</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021073</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19990715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Monotherapy and Combination Therapy. ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
    <Description>ACTOS tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>64764-251-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64764-251-05) </PackageDescription>
    <NDC11Code>64764-0251-05</NDC11Code>
    <ProductNDC>64764-251</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseni</ProprietaryName>
    <NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022426</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25; 15</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone.</Description>
  </NDC>
  <NDC>
    <NDCCode>64764-253-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64764-253-05) </PackageDescription>
    <NDC11Code>64764-0253-05</NDC11Code>
    <ProductNDC>64764-253</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseni</ProprietaryName>
    <NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022426</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone.</Description>
  </NDC>
  <NDC>
    <NDCCode>64764-254-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64764-254-05) </PackageDescription>
    <NDC11Code>64764-0254-05</NDC11Code>
    <ProductNDC>64764-254</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseni</ProprietaryName>
    <NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022426</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25; 45</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone.</Description>
  </NDC>
  <NDC>
    <NDCCode>64764-541-05</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 TRAY (64764-541-05)  &gt; 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64764-0541-05</NDC11Code>
    <ProductNDC>64764-541</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevacid</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950510</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020406</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>64764-543-05</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 TRAY (64764-543-05)  / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64764-0543-05</NDC11Code>
    <ProductNDC>64764-543</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevacid Solutab</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020830</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021428</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
    <Description>The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&amp;C Red No. 28, FD&amp;C Blue No. 1, and FD&amp;C Red No. 40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartamePhenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet., glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>64764-544-05</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 TRAY (64764-544-05)  / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64764-0544-05</NDC11Code>
    <ProductNDC>64764-544</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevacid Solutab</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020830</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021428</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
    <Description>The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&amp;C Red No. 28, FD&amp;C Blue No. 1, and FD&amp;C Red No. 40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartamePhenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet., glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0135-0246-05</NDCCode>
    <PackageDescription>140 TABLET, CHEWABLE in 1 BOTTLE (0135-0246-05) </PackageDescription>
    <NDC11Code>00135-0246-05</NDC11Code>
    <ProductNDC>0135-0246</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tums</ProprietaryName>
    <ProprietaryNameSuffix>Smoothies</ProprietaryNameSuffix>
    <NonProprietaryName>Calcium Carbonate</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100324</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M001</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>CALCIUM CARBONATE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0135-0456-05</NDCCode>
    <PackageDescription>140 TABLET, CHEWABLE in 1 BOTTLE (0135-0456-05) </PackageDescription>
    <NDC11Code>00135-0456-05</NDC11Code>
    <ProductNDC>0135-0456</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tums</ProprietaryName>
    <ProprietaryNameSuffix>Smoothies</ProprietaryNameSuffix>
    <NonProprietaryName>Calcium Carbonate</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100324</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M001</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>CALCIUM CARBONATE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0135-0542-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (0135-0542-01)  *  140 TABLET, CHEWABLE in 1 BOTTLE (0135-0456-05)  *  1 BOTTLE in 1 CARTON (0135-0522-02)  &gt; 25 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
    <NDC11Code>00135-0542-01</NDC11Code>
    <ProductNDC>0135-0542</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tums</ProprietaryName>
    <NonProprietaryName>Calcium Carbonate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20120914</StartMarketingDate>
    <EndMarketingDate>20140228</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Consumer Heathcare LP</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-03-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10631-278-05</NDCCode>
    <PackageDescription>140 g in 1 BOTTLE, PLASTIC (10631-278-05)</PackageDescription>
    <NDC11Code>10631-0278-05</NDC11Code>
    <ProductNDC>10631-278</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Desquam-x Wash</ProprietaryName>
    <NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110426</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>Ranbaxy Laboratories Inc.</LabelerName>
    <SubstanceName>BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10631-279-05</NDCCode>
    <PackageDescription>140 g in 1 BOTTLE, PLASTIC (10631-279-05)</PackageDescription>
    <NDC11Code>10631-0279-05</NDC11Code>
    <ProductNDC>10631-279</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Desquam-x Wash</ProprietaryName>
    <NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110426</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>Ranbaxy Laboratories Inc.</LabelerName>
    <SubstanceName>BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>12745-140-05</NDCCode>
    <PackageDescription>208198 mL in 1 BOTTLE, PLASTIC (12745-140-05)</PackageDescription>
    <NDC11Code>12745-0140-05</NDC11Code>
    <ProductNDC>12745-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tincture Green Soap</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19540615</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Medical Chemical Corporation</LabelerName>
    <SubstanceName>ROSIN; POTASSIUM HYDROXIDE; ALCOHOL</SubstanceName>
    <StrengthNumber>2.47; 5.961; 24.93</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>13668-140-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13668-140-05) </PackageDescription>
    <NDC11Code>13668-0140-05</NDC11Code>
    <ProductNDC>13668-140</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pioglitazonehydrochloride</ProprietaryName>
    <NonProprietaryName>Pioglitazonehydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091298</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>23155-140-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (23155-140-05)</PackageDescription>
    <NDC11Code>23155-0140-05</NDC11Code>
    <ProductNDC>23155-140</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079237</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>29300-140-05</NDCCode>
    <PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-140-05) </PackageDescription>
    <NDC11Code>29300-0140-05</NDC11Code>
    <ProductNDC>29300-140</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Divalproex Sodium</ProprietaryName>
    <NonProprietaryName>Divalproex Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079163</ApplicationNumber>
    <LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
    <SubstanceName>DIVALPROEX SODIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
    <Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration.  Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD &amp; C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate &amp; yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D &amp; C Red No. 30, FD &amp; C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD &amp; C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42043-140-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (42043-140-05) </PackageDescription>
    <NDC11Code>42043-0140-05</NDC11Code>
    <ProductNDC>42043-140</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071212</StartMarketingDate>
    <EndMarketingDate>20200831</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065248</ApplicationNumber>
    <LabelerName>OrchidPharma Inc</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20071212</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46144-140-05</NDCCode>
    <PackageDescription>5 g in 1 BOTTLE, PLASTIC (46144-140-05)</PackageDescription>
    <NDC11Code>46144-0140-05</NDC11Code>
    <ProductNDC>46144-140</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Liothyronine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140408</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>API Solutions, Inc.</LabelerName>
    <SubstanceName>LIOTHYRONINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49632-140-05</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (49632-140-05)  / 1 kg in 1 BAG</PackageDescription>
    <NDC11Code>49632-0140-05</NDC11Code>
    <ProductNDC>49632-140</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Domiphen Bromide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230412</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>PMC Isochem</LabelerName>
    <SubstanceName>DOMIPHEN BROMIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-05-10</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-APR-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51660-140-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (51660-140-05) </PackageDescription>
    <NDC11Code>51660-0140-05</NDC11Code>
    <ProductNDC>51660-140</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140707</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077492</ApplicationNumber>
    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3) .</IndicationAndUsage>
    <Description>Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is:. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, soluble in methanol, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, ferric oxide black (in 160 mg and 320 mg strength), ferric oxide red (in 80 mg, 160 mg, and 320 mg strength), ferric oxide yellow (in 40 mg, 80 mg, and 320 mg strength), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, talc, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>51769-140-05</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE, PLASTIC (51769-140-05)</PackageDescription>
    <NDC11Code>51769-0140-05</NDC11Code>
    <ProductNDC>51769-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Head And Shoulders</ProprietaryName>
    <ProprietaryNameSuffix>Hair Loss Prevention</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>ALL NATURAL DYNAMICS</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>.01</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff. helps prevent hair loss.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51879-140-51</NDCCode>
    <PackageDescription>50 PACKET in 1 CARTON (51879-140-51)  &gt; 14.17 g in 1 PACKET (51879-140-05)</PackageDescription>
    <NDC11Code>51879-0140-51</NDC11Code>
    <ProductNDC>51879-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tecnu Extreme</ProprietaryName>
    <NonProprietaryName>Grindelia Robusta</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20041220</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Tec Laboratories, Inc.</LabelerName>
    <SubstanceName>GRINDELIA HIRSUTULA FLOWERING TOP</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>[hp_X]/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>52389-670-05</NDCCode>
    <PackageDescription>140 g in 1 TUBE (52389-670-05) </PackageDescription>
    <NDC11Code>52389-0670-05</NDC11Code>
    <ProductNDC>52389-670</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Psoriasin In-shower</ProprietaryName>
    <ProprietaryNameSuffix>Treatment</ProprietaryNameSuffix>
    <NonProprietaryName>Coal Tar</NonProprietaryName>
    <DosageFormName>LOTION/SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210303</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Kobayashi Healthcare International, Inc.</LabelerName>
    <SubstanceName>COAL TAR</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the relief of symptoms of psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irriation of the skin. Helps prevent recurrence.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>64764-140-05</NDCCode><ProprietaryName>Adzynma</ProprietaryName><NonProprietaryName>Apadamtase Alfa</NonProprietaryName></NDC><NDC><NDCCode>0944-4177-05</NDCCode><ProprietaryName>Ceprotin</ProprietaryName><NonProprietaryName>Protein C Concentrate Human</NonProprietaryName></NDC><NDC><NDCCode>64764-119-05</NDCCode><ProprietaryName>Colcrys</ProprietaryName><NonProprietaryName>Colchicine</NonProprietaryName></NDC><NDC><NDCCode>64764-121-05</NDCCode><ProprietaryName>Oseni</ProprietaryName><NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName></NDC><NDC><NDCCode>64764-123-05</NDCCode><ProprietaryName>Oseni</ProprietaryName><NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName></NDC><NDC><NDCCode>64764-124-05</NDCCode><ProprietaryName>Oseni</ProprietaryName><NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName></NDC><NDC><NDCCode>64764-145-05</NDCCode><ProprietaryName>Adzynma</ProprietaryName><NonProprietaryName>Apadamtase Alfa</NonProprietaryName></NDC><NDC><NDCCode>64764-151-05</NDCCode><ProprietaryName>Actos</ProprietaryName><NonProprietaryName>Pioglitazone</NonProprietaryName></NDC><NDC><NDCCode>64764-251-05</NDCCode><ProprietaryName>Oseni</ProprietaryName><NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName></NDC><NDC><NDCCode>64764-253-05</NDCCode><ProprietaryName>Oseni</ProprietaryName><NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName></NDC><NDC><NDCCode>64764-254-05</NDCCode><ProprietaryName>Oseni</ProprietaryName><NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName></NDC><NDC><NDCCode>64764-541-05</NDCCode><ProprietaryName>Prevacid</ProprietaryName><NonProprietaryName>Lansoprazole</NonProprietaryName></NDC><NDC><NDCCode>64764-543-05</NDCCode><ProprietaryName>Prevacid Solutab</ProprietaryName><NonProprietaryName>Lansoprazole</NonProprietaryName></NDC><NDC><NDCCode>64764-544-05</NDCCode><ProprietaryName>Prevacid Solutab</ProprietaryName><NonProprietaryName>Lansoprazole</NonProprietaryName></NDC><NDC><NDCCode>0135-0246-05</NDCCode><ProprietaryName>Tums</ProprietaryName><NonProprietaryName>Calcium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>0135-0456-05</NDCCode><ProprietaryName>Tums</ProprietaryName><NonProprietaryName>Calcium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>0135-0542-01</NDCCode><ProprietaryName>Tums</ProprietaryName><NonProprietaryName>Calcium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>10631-278-05</NDCCode><ProprietaryName>Desquam-x Wash</ProprietaryName><NonProprietaryName>Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>10631-279-05</NDCCode><ProprietaryName>Desquam-x Wash</ProprietaryName><NonProprietaryName>Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>12745-140-05</NDCCode><ProprietaryName>Tincture Green Soap</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>13668-140-05</NDCCode><ProprietaryName>Pioglitazonehydrochloride</ProprietaryName><NonProprietaryName>Pioglitazonehydrochloride</NonProprietaryName></NDC><NDC><NDCCode>23155-140-05</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>29300-140-05</NDCCode><ProprietaryName>Divalproex Sodium</ProprietaryName><NonProprietaryName>Divalproex Sodium</NonProprietaryName></NDC><NDC><NDCCode>42043-140-05</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC><NDC><NDCCode>46144-140-05</NDCCode><NonProprietaryName>Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>49632-140-05</NDCCode><NonProprietaryName>Domiphen Bromide</NonProprietaryName></NDC><NDC><NDCCode>51660-140-05</NDCCode><ProprietaryName>Valsartan</ProprietaryName><NonProprietaryName>Valsartan</NonProprietaryName></NDC><NDC><NDCCode>51769-140-05</NDCCode><ProprietaryName>Head And Shoulders</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>51879-140-51</NDCCode><ProprietaryName>Tecnu Extreme</ProprietaryName><NonProprietaryName>Grindelia Robusta</NonProprietaryName></NDC><NDC><NDCCode>52389-670-05</NDCCode><ProprietaryName>Psoriasin In-shower</ProprietaryName><NonProprietaryName>Coal Tar</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",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "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."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
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      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
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      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
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      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
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      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
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      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
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      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
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      "MailingAddressCountryCode": "US",
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      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
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      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
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      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "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."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
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      "MailingAddressStateName": "WA",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
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      "PracticeLocationAddressCountryCode": "US",
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      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
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      "AuthorizedOfficialCredential": "MD PHD",
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      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
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      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
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      "OtherIdentifierIssuer1": "NPI",
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      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
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      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
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    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
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      "PracticeLocationAddressCountryCode": "US",
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      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
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      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
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    {
      "NPI": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
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      "MailingAddressCityName": "REDMOND",
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      "PracticeLocationAddressFaxNumber": "425-562-2010",
      "EnumerationDate": "10/26/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "WONG",
      "AuthorizedOfficialFirstName": "TONY",
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      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "WA 3422 TX",
      "LicenseNumberStateCode1": "WA",
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      "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."
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    {
      "NPI": "1760539969",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "DR TIFFANY J HOLLENBECK PLLC",
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    {
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      "MailingAddressCountryCode": "US",
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      "PracticeLocationAddressCountryCode": "US",
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      "PracticeLocationAddressFaxNumber": "518-747-6151",
      "EnumerationDate": "01/25/2007",
      "LastUpdateDate": "08/29/2011",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "MONICA",
      "AuthorizedOfficialTitle": "OPTOMETRIST",
      "AuthorizedOfficialCredential": "OD",
      "AuthorizedOfficialTelephoneNumber": "518-747-4100",
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      "Taxonomy1": "Corneal and Contact Management",
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      "LicenseNumberStateCode1": "NY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "152WP0200X",
      "Taxonomy2": "Pediatrics",
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      "PrimaryTaxonomySwitch2": "Y",
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      "Taxonomy3": "Sports Vision",
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      "LicenseNumberStateCode3": "NY",
      "PrimaryTaxonomySwitch3": "N",
      "OtherIdentifier1": "10089360",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "NY",
      "OtherIdentifierIssuer1": "CDPHP",
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      "OtherIdentifierIssuer2": "EMPIRE",
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      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
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    {
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    {
      "NPI": "1437480456",
      "EntityType": "Organization",
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      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "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",
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}
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