RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (42 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "55566-9300-2",
      "PackageDescription": "2 PACKET in 1 CARTON (55566-9300-2)  > 16.1 g in 1 PACKET (55566-9300-0) ",
      "NDC11Code": "55566-9300-02",
      "ProductNDC": "55566-9300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prepopik",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120716",
      "EndMarketingDate": "20200531",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202535",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID",
      "StrengthNumber": "10; 3.5; 12",
      "StrengthUnit": "mg/16.1g; g/16.1g; g/16.1g",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120716",
      "EndMarketingDatePackage": "20200531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "22840-9300-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-9300-2) ",
      "NDC11Code": "22840-9300-02",
      "ProductNDC": "22840-9300",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "3 Weed Mix",
      "NonProprietaryName": "Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19810915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101833",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; XANTHIUM STRUMARIUM POLLEN",
      "StrengthNumber": "6666.666; 6666.666; 6666.666",
      "StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19810915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
      "Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
    },
    {
      "NDCCode": "39822-9300-2",
      "PackageDescription": "10 AMPULE in 1 CARTON (39822-9300-2)  / 5 mL in 1 AMPULE (39822-9300-1) ",
      "NDC11Code": "39822-9300-02",
      "ProductNDC": "39822-9300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dehydrated Alcohol",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS",
      "StartMarketingDate": "20250624",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219400",
      "LabelerName": "XGen Pharmaceuticals DJB, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "1",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2025-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250624",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.",
      "Description": "Dehydrated alcohol injection, USP is a sterile, preservative-free solution of ≥ 99% by volume ethyl alcohol and no excipients. Dehydrated alcohol injection, USP is for cardiac septal branch intra-arterial use. It has a molecular formula of C 2H 6O and a molecular weight of 46.07. Dehydrated alcohol injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water. It has the following structural formula."
    },
    {
      "NDCCode": "68788-9300-2",
      "PackageDescription": "20 TABLET in 1 BOTTLE (68788-9300-2) ",
      "NDC11Code": "68788-9300-02",
      "ProductNDC": "68788-9300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen And Codeine Phosphate",
      "NonProprietaryName": "Acetaminophen And Codeine Phosphate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150326",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202800",
      "LabelerName": "Preferred Pharmaceuticals, Inc.",
      "SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
      "StrengthNumber": "300; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150326",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-0302-1",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (55566-0302-1)  > 2 mL in 1 VIAL, GLASS",
      "NDC11Code": "55566-0302-01",
      "ProductNDC": "55566-0302",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acthrel",
      "NonProprietaryName": "Corticorelin Ovine Triflutate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19960523",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA020162",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "CORTICORELIN OVINE TRIFLUTATE",
      "StrengthNumber": "100",
      "StrengthUnit": "ug/2mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "19960523",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-1050-2",
      "PackageDescription": "20 mL in 1 VIAL (55566-1050-2) ",
      "NDC11Code": "55566-1050-02",
      "ProductNDC": "55566-1050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adstiladrin",
      "NonProprietaryName": "Nadofaragene Firadenovec-vncg",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAVESICAL",
      "StartMarketingDate": "20230905",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125700",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "NADOFARAGENE FIRADENOVEC",
      "StrengthNumber": "300000000000",
      "StrengthUnit": "{VP}/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251013",
      "SamplePackage": "N",
      "IndicationAndUsage": "ADSTILADRIN® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.",
      "Description": "ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation. It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b). ADSTILADRIN has a nominal concentration of 3 x 1011 vp/mL. A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL). ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative."
    },
    {
      "NDCCode": "55566-2100-2",
      "PackageDescription": "1 BOTTLE in 1 CARTON (55566-2100-2)  > 30 TABLET in 1 BOTTLE",
      "NDC11Code": "55566-2100-02",
      "ProductNDC": "55566-2100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lysteda",
      "NonProprietaryName": "Tranexamic Acid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100517",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022430",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "TRANEXAMIC ACID",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "55566-2110-2",
      "PackageDescription": "30 TABLET in 1 BOTTLE (55566-2110-2) ",
      "NDC11Code": "55566-2110-02",
      "ProductNDC": "55566-2110",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lysteda",
      "NonProprietaryName": "Tranexamic Acid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100517",
      "EndMarketingDate": "20221231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022430",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "TRANEXAMIC ACID",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100517",
      "EndMarketingDatePackage": "20221231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-2400-0",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (55566-2400-0)  > 2.5 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "55566-2400-00",
      "ProductNDC": "55566-2400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ddavp",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "19780221",
      "EndMarketingDate": "20210731",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017922",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19780221",
      "EndMarketingDatePackage": "20210731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-3000-0",
      "PackageDescription": "2.5 mL in 1 BOTTLE, SPRAY (55566-3000-0) ",
      "NDC11Code": "55566-3000-00",
      "ProductNDC": "55566-3000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stimate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20250625",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020355",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250625",
      "SamplePackage": "N",
      "IndicationAndUsage": "STIMATE is a vasopressin analog used for: 1 Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.1), 2 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2).",
      "Description": "STIMATE (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Molecular weight: 1183.34. Empirical formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. STIMATE is an aqueous solution for intranasal use.  Each mL contains: Benzalkonium chloride solution 0.1 mg, Citric acid monohydrate 1.7 mg, Desmopressin acetate 1.5 mg, Disodium phosphate dihydrate 3 mg, Purified water to 1 mL, Sodium chloride 7.5 mg."
    },
    {
      "NDCCode": "55566-5020-1",
      "PackageDescription": "1 VIAL in 1 CARTON (55566-5020-1)  > 2.5 mL in 1 VIAL",
      "NDC11Code": "55566-5020-01",
      "ProductNDC": "55566-5020",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desmopressin Acetate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "SOLUTION",
      "RouteName": "NASAL",
      "StartMarketingDate": "19990810",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017922",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "55566-5020-2",
      "PackageDescription": "10 VIAL in 1 CARTON (55566-5020-2)  > 2.5 mL in 1 VIAL",
      "NDC11Code": "55566-5020-02",
      "ProductNDC": "55566-5020",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desmopressin Acetate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "SOLUTION",
      "RouteName": "NASAL",
      "StartMarketingDate": "19990810",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017922",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "55566-6500-3",
      "PackageDescription": "1 CARTON in 1 CARTON (55566-6500-3)  / 21 BLISTER PACK in 1 CARTON (55566-6500-2)  / 1 INSERT in 1 BLISTER PACK (55566-6500-1) ",
      "NDC11Code": "55566-6500-03",
      "ProductNDC": "55566-6500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Endometrin",
      "NonProprietaryName": "Progesterone",
      "DosageFormName": "INSERT",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20070621",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022057",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "PROGESTERONE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070621",
      "SamplePackage": "N",
      "IndicationAndUsage": "ENDOMETRIN® is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.",
      "Description": "ENDOMETRIN (progesterone) vaginal insert contains micronized progesterone. ENDOMETRIN is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present (100 mg) along with inactive ingredients. The chemical name for progesterone is pregn-4-ene-3,20-dione, its empirical formula is C21H30O2, its molecular weight is 314.5. Progesterone exists in two polymorphic forms. The form used in ENDOMETRIN, the alpha-form, has a melting point of 127-131°C. The structural formula is. Each ENDOMETRIN vaginal insert delivers 100 mg of progesterone in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide."
    },
    {
      "NDCCode": "55566-6700-1",
      "PackageDescription": "2 BOTTLE in 1 CARTON (55566-6700-1)  > 160 mL in 1 BOTTLE (55566-6700-0) ",
      "NDC11Code": "55566-6700-01",
      "ProductNDC": "55566-6700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clenpiq",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180629",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209589",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE",
      "StrengthNumber": "12; 3.5; 10",
      "StrengthUnit": "g/160mL; g/160mL; mg/160mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180629",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.",
      "Description": "CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative."
    },
    {
      "NDCCode": "55566-6800-1",
      "PackageDescription": "2 BOTTLE in 1 CARTON (55566-6800-1)  / 175 mL in 1 BOTTLE (55566-6800-0) ",
      "NDC11Code": "55566-6800-01",
      "ProductNDC": "55566-6800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clenpiq",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230329",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209589",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID",
      "StrengthNumber": "10; 3.5; 12",
      "StrengthUnit": "mg/175mL; g/175mL; g/175mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230329",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.",
      "Description": "CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative."
    },
    {
      "NDCCode": "55566-6800-2",
      "PackageDescription": "2 BOTTLE in 1 CARTON (55566-6800-2)  / 175 mL in 1 BOTTLE (55566-6800-0) ",
      "NDC11Code": "55566-6800-02",
      "ProductNDC": "55566-6800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clenpiq",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230329",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209589",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID",
      "StrengthNumber": "10; 3.5; 12",
      "StrengthUnit": "mg/175mL; g/175mL; g/175mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230330",
      "SamplePackage": "Y",
      "IndicationAndUsage": "CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.",
      "Description": "CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative."
    },
    {
      "NDCCode": "55566-7185-2",
      "PackageDescription": "5 CARTON in 1 CARTON (55566-7185-2)  > 1 KIT in 1 CARTON (55566-7185-0)  *  2 mL in 1 VIAL, SINGLE-USE *  2 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "55566-7185-02",
      "ProductNDC": "55566-7185",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Repronex",
      "NonProprietaryName": "Menotropins",
      "DosageFormName": "KIT",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "19990827",
      "EndMarketingDate": "20141231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021047",
      "LabelerName": "Ferring Pharmaceuticals",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-02"
    },
    {
      "NDCCode": "55566-7501-2",
      "PackageDescription": "1 CARTON in 1 CARTON (55566-7501-2)  / 1 KIT in 1 CARTON (55566-7501-1)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55566-7502-0)  *  1 INJECTION in 1 VIAL (55566-1600-0) ",
      "NDC11Code": "55566-7501-02",
      "ProductNDC": "55566-7501",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Menopur",
      "NonProprietaryName": "Menotropins",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20041029",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA021663",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "Status": "Active",
      "LastUpdate": "2026-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20041029",
      "SamplePackage": "N",
      "IndicationAndUsage": "MENOPUR® (menotropins for injection) is a gonadotropin indicated for: 1 Development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1).",
      "Description": "MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification. MENOPUR is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of MENOPUR contains 75 International Units of follicle-stimulating hormone (FSH) activity and 75 International Units of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid). The biological activity of MENOPUR is determined using the bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the World Health Organization (WHO ECBS). Both FSH and LH are glycoproteins that are acidic and water-soluble. Human Chorionic Gonadotropin (hCG) is detected in MENOPUR. MENOPUR has been mixed in vitro with BRAVELLE with no evidence of aggregation. Therapeutic class: Infertility."
    },
    {
      "NDCCode": "55566-8301-2",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (55566-8301-2)  > 4 mL in 1 VIAL, GLASS (55566-8301-0)",
      "NDC11Code": "55566-8301-02",
      "ProductNDC": "55566-8301",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Firmagon",
      "NonProprietaryName": "Degarelix",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20090302",
      "EndMarketingDate": "20150331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022201",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DEGARELIX ACETATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-04-03"
    },
    {
      "NDCCode": "55566-8303-1",
      "PackageDescription": "1 KIT in 1 CARTON (55566-8303-1)  *  4 mL in 1 VIAL, GLASS *  4.2 mL in 1 SYRINGE",
      "NDC11Code": "55566-8303-01",
      "ProductNDC": "55566-8303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Firmagon",
      "NonProprietaryName": "Degarelix",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20090302",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022201",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090302",
      "SamplePackage": "N",
      "IndicationAndUsage": "FIRMAGON® is indicated for treatment of patients with advanced prostate cancer.",
      "Description": "FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization. The chemical name of degarelix is D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl-N6–(1-methylethyl)-L-lysyl-L-prolyl. It has an empirical formula of C82H103N18O16Cl and a molecular weight of 1632.3 Da. Degarelix acetate has the following structural formula. FIRMAGON is available in two packaging configurations: 1 Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol., 2 Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol."
    },
    {
      "NDCCode": "55566-8401-1",
      "PackageDescription": "2 VIAL, GLASS in 1 CARTON (55566-8401-1)  > 3 mL in 1 VIAL, GLASS (55566-8401-0)",
      "NDC11Code": "55566-8401-01",
      "ProductNDC": "55566-8401",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Firmagon",
      "NonProprietaryName": "Degarelix",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20090302",
      "EndMarketingDate": "20150331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022201",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DEGARELIX ACETATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-04-03"
    },
    {
      "NDCCode": "55566-8401-2",
      "PackageDescription": "2 VIAL, GLASS in 1 CARTON (55566-8401-2)  > 3 mL in 1 VIAL, GLASS (55566-8401-0)",
      "NDC11Code": "55566-8401-02",
      "ProductNDC": "55566-8401",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Firmagon",
      "NonProprietaryName": "Degarelix",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20090302",
      "EndMarketingDate": "20150331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022201",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DEGARELIX ACETATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-04-03"
    },
    {
      "NDCCode": "55566-8505-6",
      "PackageDescription": "1 CARTON in 1 CARTON (55566-8505-6)  > 1 KIT in 1 CARTON (55566-8505-2)  *  1 mL in 1 VIAL *  1 mL in 1 VIAL (0641-0495-17)",
      "NDC11Code": "55566-8505-06",
      "ProductNDC": "55566-8505",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bravelle",
      "NonProprietaryName": "Urofollitropin",
      "DosageFormName": "KIT",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20020506",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021289",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-30",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "55566-9400-1",
      "PackageDescription": "2 POUCH in 1 CARTON (55566-9400-1)  > 7 d in 1 POUCH (55566-9400-0) ",
      "NDC11Code": "55566-9400-01",
      "ProductNDC": "55566-9400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ferring Pharmaceuticals Inc.",
      "NonProprietaryName": "Progesterone",
      "DosageFormName": "RING",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20220501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201110",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "PROGESTERONE",
      "StrengthNumber": "11",
      "StrengthUnit": "mg/d",
      "Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20220501",
      "SamplePackage": "N",
      "IndicationAndUsage": "MILPROSA is indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women up to and including 34 years of age.",
      "Description": "MILPROSA (progesterone) vaginal system is a white to off-white, flexible, non-biodegradable silicone ring (toroidal-shaped) containing 1.78 grams of progesterone. MILPROSA has a cross-sectional diameter of approximately 8.5 mm, and an outer and inner diameter of approximately 55 mm and 38 mm, respectively. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C21H30O2 and a molecular weight of 314.5. Progesterone has a melting point of 126-131°C. The structural formula is. When placed in the vagina, each vaginal system is estimated to provide an average release rate of 11 mg/day of progesterone over 7 days. The inactive components of the vaginal system are light mineral oil and silicone elastomer."
    },
    {
      "NDCCode": "55566-9700-1",
      "PackageDescription": "2 PACKET in 1 CARTON (55566-9700-1)  > 16.2 g in 1 PACKET (55566-9700-0) ",
      "NDC11Code": "55566-9700-01",
      "ProductNDC": "55566-9700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prepopik",
      "NonProprietaryName": "Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid",
      "DosageFormName": "POWDER, METERED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140905",
      "EndMarketingDate": "20200531",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202535",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID",
      "StrengthNumber": "10; 3.5; 12",
      "StrengthUnit": "mg/16.2g; g/16.2g; g/16.2g",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140905",
      "EndMarketingDatePackage": "20200531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55566-9800-2",
      "PackageDescription": "1 CARTON in 1 CARTON (55566-9800-2)  / 1 BAG in 1 CARTON (55566-9800-1)  / 150 mL in 1 BAG (55566-9800-0) ",
      "NDC11Code": "55566-9800-02",
      "ProductNDC": "55566-9800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebyota",
      "NonProprietaryName": "Donor Human Stool",
      "DosageFormName": "SUSPENSION",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20230109",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125739",
      "LabelerName": "Ferring Pharmaceuticals Inc.",
      "SubstanceName": "DONOR HUMAN STOOL",
      "StrengthNumber": "50000000000",
      "StrengthUnit": "[CFU]/150mL",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230109",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI.",
      "Description": "REBYOTA (fecal microbiota, live – jslm) is an opaque fecal microbiota suspension for rectal administration. REBYOTA is manufactured from human fecal matter sourced from qualified donors. The human fecal matter is tested for a panel of transmissible pathogens. Donors do not have dietary restrictions with respect to potential food allergens. The fecal microbiota suspension is the filtrate generated by processing the fecal matter in a pre-defined ratio with a solution of polyethylene glycol (PEG) 3350 and saline. Each 150mL dose of REBYOTA contains between 1×108 and 5×1010 colony forming units (CFU) per mL of fecal microbes including >1×105 CFU/mL of Bacteroides, and contains not greater than 5.97 grams of PEG3350 in saline."
    },
    {
      "NDCCode": "0143-9300-10",
      "PackageDescription": "10 VIAL in 1 CARTON (0143-9300-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9300-01) ",
      "NDC11Code": "00143-9300-10",
      "ProductNDC": "0143-9300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium",
      "NonProprietaryName": "Pantoprazole Sodium",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170922",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209463",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170922",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated in adults for the following.   Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE). (1.1).   Pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome. (1.2).",
      "Description": "The active ingredient in Pantoprazole Sodium for Injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S1.5 H2O, with a molecular weight of 432.37. The structural formula is:. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of Pantoprazole Sodium for Injection is in the pH range 9.5 to 11.5. Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile lyophilized powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), and sodium hydroxide to adjust pH."
    },
    {
      "NDCCode": "0409-9300-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9300-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9300-11) ",
      "NDC11Code": "00409-9300-10",
      "ProductNDC": "0409-9300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ropivacaine Hydrochloride",
      "NonProprietaryName": "Ropivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20141107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090194",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20141107",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0409-9300-20",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9300-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (0409-9300-21) ",
      "NDC11Code": "00409-9300-20",
      "ProductNDC": "0409-9300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ropivacaine Hydrochloride",
      "NonProprietaryName": "Ropivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20141107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090194",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-03-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20141107",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ropivacaine Hydrochloride Injection, USP is indicated for the production of local or regional anesthesia for surgery and for acute pain management.",
      "Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is administered parenterally by infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O            M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n‑octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.12 mg, 5.3 mg, 7.95 mg, or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg, or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg, or 7.1 mg of sodium chloride, respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
    },
    {
      "NDCCode": "22840-9300-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-9300-4) ",
      "NDC11Code": "22840-9300-04",
      "ProductNDC": "22840-9300",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "3 Weed Mix",
      "NonProprietaryName": "Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19810915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101833",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; XANTHIUM STRUMARIUM POLLEN",
      "StrengthNumber": "6666.666; 6666.666; 6666.666",
      "StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19810915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
      "Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"55566-9300-2","ProprietaryName":"Prepopik","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"22840-9300-2","ProprietaryName":"3 Weed Mix","NonProprietaryName":"Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus"},{"NDCCode":"39822-9300-2","ProprietaryName":"Dehydrated Alcohol","NonProprietaryName":"Alcohol"},{"NDCCode":"68788-9300-2","ProprietaryName":"Acetaminophen And Codeine Phosphate","NonProprietaryName":"Acetaminophen And Codeine Phosphate"},{"NDCCode":"55566-0302-1","ProprietaryName":"Acthrel","NonProprietaryName":"Corticorelin Ovine Triflutate"},{"NDCCode":"55566-1050-2","ProprietaryName":"Adstiladrin","NonProprietaryName":"Nadofaragene Firadenovec-vncg"},{"NDCCode":"55566-2100-2","ProprietaryName":"Lysteda","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"55566-2110-2","ProprietaryName":"Lysteda","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"55566-2400-0","ProprietaryName":"Ddavp","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-3000-0","ProprietaryName":"Stimate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-5020-1","ProprietaryName":"Desmopressin Acetate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-5020-2","ProprietaryName":"Desmopressin Acetate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"55566-6500-3","ProprietaryName":"Endometrin","NonProprietaryName":"Progesterone"},{"NDCCode":"55566-6700-1","ProprietaryName":"Clenpiq","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"55566-6800-1","ProprietaryName":"Clenpiq","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"55566-6800-2","ProprietaryName":"Clenpiq","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"55566-7185-2","ProprietaryName":"Repronex","NonProprietaryName":"Menotropins"},{"NDCCode":"55566-7501-2","ProprietaryName":"Menopur","NonProprietaryName":"Menotropins"},{"NDCCode":"55566-8301-2","ProprietaryName":"Firmagon","NonProprietaryName":"Degarelix"},{"NDCCode":"55566-8303-1","ProprietaryName":"Firmagon","NonProprietaryName":"Degarelix"},{"NDCCode":"55566-8401-1","ProprietaryName":"Firmagon","NonProprietaryName":"Degarelix"},{"NDCCode":"55566-8401-2","ProprietaryName":"Firmagon","NonProprietaryName":"Degarelix"},{"NDCCode":"55566-8505-6","ProprietaryName":"Bravelle","NonProprietaryName":"Urofollitropin"},{"NDCCode":"55566-9400-1","ProprietaryName":"Ferring Pharmaceuticals Inc.","NonProprietaryName":"Progesterone"},{"NDCCode":"55566-9700-1","ProprietaryName":"Prepopik","NonProprietaryName":"Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid"},{"NDCCode":"55566-9800-2","ProprietaryName":"Rebyota","NonProprietaryName":"Donor Human Stool"},{"NDCCode":"0143-9300-10","ProprietaryName":"Pantoprazole Sodium","NonProprietaryName":"Pantoprazole Sodium"},{"NDCCode":"0409-9300-10","ProprietaryName":"Ropivacaine Hydrochloride","NonProprietaryName":"Ropivacaine Hydrochloride"},{"NDCCode":"0409-9300-20","ProprietaryName":"Ropivacaine Hydrochloride","NonProprietaryName":"Ropivacaine Hydrochloride"},{"NDCCode":"22840-9300-4","ProprietaryName":"3 Weed Mix","NonProprietaryName":"Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus"}]}
                    

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<NDCList>
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    <NDCCode>55566-9300-2</NDCCode>
    <PackageDescription>2 PACKET in 1 CARTON (55566-9300-2)  &gt; 16.1 g in 1 PACKET (55566-9300-0) </PackageDescription>
    <NDC11Code>55566-9300-02</NDC11Code>
    <ProductNDC>55566-9300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prepopik</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120716</StartMarketingDate>
    <EndMarketingDate>20200531</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202535</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID</SubstanceName>
    <StrengthNumber>10; 3.5; 12</StrengthNumber>
    <StrengthUnit>mg/16.1g; g/16.1g; g/16.1g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120716</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>22840-9300-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-9300-2) </PackageDescription>
    <NDC11Code>22840-9300-02</NDC11Code>
    <ProductNDC>22840-9300</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>3 Weed Mix</ProprietaryName>
    <NonProprietaryName>Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; XANTHIUM STRUMARIUM POLLEN</SubstanceName>
    <StrengthNumber>6666.666; 6666.666; 6666.666</StrengthNumber>
    <StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
    <Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>39822-9300-2</NDCCode>
    <PackageDescription>10 AMPULE in 1 CARTON (39822-9300-2)  / 5 mL in 1 AMPULE (39822-9300-1) </PackageDescription>
    <NDC11Code>39822-9300-02</NDC11Code>
    <ProductNDC>39822-9300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dehydrated Alcohol</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS</RouteName>
    <StartMarketingDate>20250624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219400</ApplicationNumber>
    <LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.</IndicationAndUsage>
    <Description>Dehydrated alcohol injection, USP is a sterile, preservative-free solution of ≥ 99% by volume ethyl alcohol and no excipients. Dehydrated alcohol injection, USP is for cardiac septal branch intra-arterial use. It has a molecular formula of C 2H 6O and a molecular weight of 46.07. Dehydrated alcohol injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water. It has the following structural formula.</Description>
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  <NDC>
    <NDCCode>68788-9300-2</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (68788-9300-2) </PackageDescription>
    <NDC11Code>68788-9300-02</NDC11Code>
    <ProductNDC>68788-9300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
    <NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202800</ApplicationNumber>
    <LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
    <StrengthNumber>300; 60</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-0302-1</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (55566-0302-1)  &gt; 2 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>55566-0302-01</NDC11Code>
    <ProductNDC>55566-0302</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acthrel</ProprietaryName>
    <NonProprietaryName>Corticorelin Ovine Triflutate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19960523</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA020162</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CORTICORELIN OVINE TRIFLUTATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>ug/2mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-1050-2</NDCCode>
    <PackageDescription>20 mL in 1 VIAL (55566-1050-2) </PackageDescription>
    <NDC11Code>55566-1050-02</NDC11Code>
    <ProductNDC>55566-1050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adstiladrin</ProprietaryName>
    <NonProprietaryName>Nadofaragene Firadenovec-vncg</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>INTRAVESICAL</RouteName>
    <StartMarketingDate>20230905</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125700</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>NADOFARAGENE FIRADENOVEC</SubstanceName>
    <StrengthNumber>300000000000</StrengthNumber>
    <StrengthUnit>{VP}/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADSTILADRIN® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.</IndicationAndUsage>
    <Description>ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation. It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b). ADSTILADRIN has a nominal concentration of 3 x 1011 vp/mL. A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL). ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-2100-2</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (55566-2100-2)  &gt; 30 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>55566-2100-02</NDC11Code>
    <ProductNDC>55566-2100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lysteda</ProprietaryName>
    <NonProprietaryName>Tranexamic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100517</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022430</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TRANEXAMIC ACID</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55566-2110-2</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (55566-2110-2) </PackageDescription>
    <NDC11Code>55566-2110-02</NDC11Code>
    <ProductNDC>55566-2110</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lysteda</ProprietaryName>
    <NonProprietaryName>Tranexamic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100517</StartMarketingDate>
    <EndMarketingDate>20221231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022430</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TRANEXAMIC ACID</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100517</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-2400-0</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (55566-2400-0)  &gt; 2.5 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>55566-2400-00</NDC11Code>
    <ProductNDC>55566-2400</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ddavp</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>19780221</StartMarketingDate>
    <EndMarketingDate>20210731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017922</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19780221</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-3000-0</NDCCode>
    <PackageDescription>2.5 mL in 1 BOTTLE, SPRAY (55566-3000-0) </PackageDescription>
    <NDC11Code>55566-3000-00</NDC11Code>
    <ProductNDC>55566-3000</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stimate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20250625</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020355</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STIMATE is a vasopressin analog used for: 1 Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.1), 2 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2).</IndicationAndUsage>
    <Description>STIMATE (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Molecular weight: 1183.34. Empirical formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. STIMATE is an aqueous solution for intranasal use.  Each mL contains: Benzalkonium chloride solution 0.1 mg, Citric acid monohydrate 1.7 mg, Desmopressin acetate 1.5 mg, Disodium phosphate dihydrate 3 mg, Purified water to 1 mL, Sodium chloride 7.5 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-5020-1</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (55566-5020-1)  &gt; 2.5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55566-5020-01</NDC11Code>
    <ProductNDC>55566-5020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desmopressin Acetate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>19990810</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017922</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55566-5020-2</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (55566-5020-2)  &gt; 2.5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55566-5020-02</NDC11Code>
    <ProductNDC>55566-5020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desmopressin Acetate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>19990810</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017922</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55566-6500-3</NDCCode>
    <PackageDescription>1 CARTON in 1 CARTON (55566-6500-3)  / 21 BLISTER PACK in 1 CARTON (55566-6500-2)  / 1 INSERT in 1 BLISTER PACK (55566-6500-1) </PackageDescription>
    <NDC11Code>55566-6500-03</NDC11Code>
    <ProductNDC>55566-6500</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Endometrin</ProprietaryName>
    <NonProprietaryName>Progesterone</NonProprietaryName>
    <DosageFormName>INSERT</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20070621</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022057</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROGESTERONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENDOMETRIN® is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.</IndicationAndUsage>
    <Description>ENDOMETRIN (progesterone) vaginal insert contains micronized progesterone. ENDOMETRIN is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present (100 mg) along with inactive ingredients. The chemical name for progesterone is pregn-4-ene-3,20-dione, its empirical formula is C21H30O2, its molecular weight is 314.5. Progesterone exists in two polymorphic forms. The form used in ENDOMETRIN, the alpha-form, has a melting point of 127-131°C. The structural formula is. Each ENDOMETRIN vaginal insert delivers 100 mg of progesterone in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-6700-1</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (55566-6700-1)  &gt; 160 mL in 1 BOTTLE (55566-6700-0) </PackageDescription>
    <NDC11Code>55566-6700-01</NDC11Code>
    <ProductNDC>55566-6700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clenpiq</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180629</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209589</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE</SubstanceName>
    <StrengthNumber>12; 3.5; 10</StrengthNumber>
    <StrengthUnit>g/160mL; g/160mL; mg/160mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180629</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.</IndicationAndUsage>
    <Description>CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-6800-1</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (55566-6800-1)  / 175 mL in 1 BOTTLE (55566-6800-0) </PackageDescription>
    <NDC11Code>55566-6800-01</NDC11Code>
    <ProductNDC>55566-6800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clenpiq</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230329</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209589</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID</SubstanceName>
    <StrengthNumber>10; 3.5; 12</StrengthNumber>
    <StrengthUnit>mg/175mL; g/175mL; g/175mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.</IndicationAndUsage>
    <Description>CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-6800-2</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (55566-6800-2)  / 175 mL in 1 BOTTLE (55566-6800-0) </PackageDescription>
    <NDC11Code>55566-6800-02</NDC11Code>
    <ProductNDC>55566-6800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clenpiq</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230329</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209589</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID</SubstanceName>
    <StrengthNumber>10; 3.5; 12</StrengthNumber>
    <StrengthUnit>mg/175mL; g/175mL; g/175mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230330</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.</IndicationAndUsage>
    <Description>CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients. acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ. Sodium picosulfate is a stimulant laxative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-7185-2</NDCCode>
    <PackageDescription>5 CARTON in 1 CARTON (55566-7185-2)  &gt; 1 KIT in 1 CARTON (55566-7185-0)  *  2 mL in 1 VIAL, SINGLE-USE *  2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>55566-7185-02</NDC11Code>
    <ProductNDC>55566-7185</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Repronex</ProprietaryName>
    <NonProprietaryName>Menotropins</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19990827</StartMarketingDate>
    <EndMarketingDate>20141231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021047</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55566-7501-2</NDCCode>
    <PackageDescription>1 CARTON in 1 CARTON (55566-7501-2)  / 1 KIT in 1 CARTON (55566-7501-1)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55566-7502-0)  *  1 INJECTION in 1 VIAL (55566-1600-0) </PackageDescription>
    <NDC11Code>55566-7501-02</NDC11Code>
    <ProductNDC>55566-7501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Menopur</ProprietaryName>
    <NonProprietaryName>Menotropins</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20041029</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA021663</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MENOPUR® (menotropins for injection) is a gonadotropin indicated for: 1 Development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1).</IndicationAndUsage>
    <Description>MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification. MENOPUR is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of MENOPUR contains 75 International Units of follicle-stimulating hormone (FSH) activity and 75 International Units of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid). The biological activity of MENOPUR is determined using the bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the World Health Organization (WHO ECBS). Both FSH and LH are glycoproteins that are acidic and water-soluble. Human Chorionic Gonadotropin (hCG) is detected in MENOPUR. MENOPUR has been mixed in vitro with BRAVELLE with no evidence of aggregation. Therapeutic class: Infertility.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-8301-2</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (55566-8301-2)  &gt; 4 mL in 1 VIAL, GLASS (55566-8301-0)</PackageDescription>
    <NDC11Code>55566-8301-02</NDC11Code>
    <ProductNDC>55566-8301</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Firmagon</ProprietaryName>
    <NonProprietaryName>Degarelix</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090302</StartMarketingDate>
    <EndMarketingDate>20150331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022201</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DEGARELIX ACETATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-04-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55566-8303-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (55566-8303-1)  *  4 mL in 1 VIAL, GLASS *  4.2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>55566-8303-01</NDC11Code>
    <ProductNDC>55566-8303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Firmagon</ProprietaryName>
    <NonProprietaryName>Degarelix</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20090302</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022201</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FIRMAGON® is indicated for treatment of patients with advanced prostate cancer.</IndicationAndUsage>
    <Description>FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization. The chemical name of degarelix is D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl-N6–(1-methylethyl)-L-lysyl-L-prolyl. It has an empirical formula of C82H103N18O16Cl and a molecular weight of 1632.3 Da. Degarelix acetate has the following structural formula. FIRMAGON is available in two packaging configurations: 1 Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol., 2 Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-8401-1</NDCCode>
    <PackageDescription>2 VIAL, GLASS in 1 CARTON (55566-8401-1)  &gt; 3 mL in 1 VIAL, GLASS (55566-8401-0)</PackageDescription>
    <NDC11Code>55566-8401-01</NDC11Code>
    <ProductNDC>55566-8401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Firmagon</ProprietaryName>
    <NonProprietaryName>Degarelix</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090302</StartMarketingDate>
    <EndMarketingDate>20150331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022201</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DEGARELIX ACETATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-04-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55566-8401-2</NDCCode>
    <PackageDescription>2 VIAL, GLASS in 1 CARTON (55566-8401-2)  &gt; 3 mL in 1 VIAL, GLASS (55566-8401-0)</PackageDescription>
    <NDC11Code>55566-8401-02</NDC11Code>
    <ProductNDC>55566-8401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Firmagon</ProprietaryName>
    <NonProprietaryName>Degarelix</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090302</StartMarketingDate>
    <EndMarketingDate>20150331</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022201</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DEGARELIX ACETATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-04-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55566-8505-6</NDCCode>
    <PackageDescription>1 CARTON in 1 CARTON (55566-8505-6)  &gt; 1 KIT in 1 CARTON (55566-8505-2)  *  1 mL in 1 VIAL *  1 mL in 1 VIAL (0641-0495-17)</PackageDescription>
    <NDC11Code>55566-8505-06</NDC11Code>
    <ProductNDC>55566-8505</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bravelle</ProprietaryName>
    <NonProprietaryName>Urofollitropin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20020506</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021289</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-30</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55566-9400-1</NDCCode>
    <PackageDescription>2 POUCH in 1 CARTON (55566-9400-1)  &gt; 7 d in 1 POUCH (55566-9400-0) </PackageDescription>
    <NDC11Code>55566-9400-01</NDC11Code>
    <ProductNDC>55566-9400</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ferring Pharmaceuticals Inc.</ProprietaryName>
    <NonProprietaryName>Progesterone</NonProprietaryName>
    <DosageFormName>RING</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20220501</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA201110</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROGESTERONE</SubstanceName>
    <StrengthNumber>11</StrengthNumber>
    <StrengthUnit>mg/d</StrengthUnit>
    <Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MILPROSA is indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women up to and including 34 years of age.</IndicationAndUsage>
    <Description>MILPROSA (progesterone) vaginal system is a white to off-white, flexible, non-biodegradable silicone ring (toroidal-shaped) containing 1.78 grams of progesterone. MILPROSA has a cross-sectional diameter of approximately 8.5 mm, and an outer and inner diameter of approximately 55 mm and 38 mm, respectively. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C21H30O2 and a molecular weight of 314.5. Progesterone has a melting point of 126-131°C. The structural formula is. When placed in the vagina, each vaginal system is estimated to provide an average release rate of 11 mg/day of progesterone over 7 days. The inactive components of the vaginal system are light mineral oil and silicone elastomer.</Description>
  </NDC>
  <NDC>
    <NDCCode>55566-9700-1</NDCCode>
    <PackageDescription>2 PACKET in 1 CARTON (55566-9700-1)  &gt; 16.2 g in 1 PACKET (55566-9700-0) </PackageDescription>
    <NDC11Code>55566-9700-01</NDC11Code>
    <ProductNDC>55566-9700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prepopik</ProprietaryName>
    <NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName>
    <DosageFormName>POWDER, METERED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140905</StartMarketingDate>
    <EndMarketingDate>20200531</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA202535</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID</SubstanceName>
    <StrengthNumber>10; 3.5; 12</StrengthNumber>
    <StrengthUnit>mg/16.2g; g/16.2g; g/16.2g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140905</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55566-9800-2</NDCCode>
    <PackageDescription>1 CARTON in 1 CARTON (55566-9800-2)  / 1 BAG in 1 CARTON (55566-9800-1)  / 150 mL in 1 BAG (55566-9800-0) </PackageDescription>
    <NDC11Code>55566-9800-02</NDC11Code>
    <ProductNDC>55566-9800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rebyota</ProprietaryName>
    <NonProprietaryName>Donor Human Stool</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20230109</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125739</ApplicationNumber>
    <LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DONOR HUMAN STOOL</SubstanceName>
    <StrengthNumber>50000000000</StrengthNumber>
    <StrengthUnit>[CFU]/150mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI.</IndicationAndUsage>
    <Description>REBYOTA (fecal microbiota, live – jslm) is an opaque fecal microbiota suspension for rectal administration. REBYOTA is manufactured from human fecal matter sourced from qualified donors. The human fecal matter is tested for a panel of transmissible pathogens. Donors do not have dietary restrictions with respect to potential food allergens. The fecal microbiota suspension is the filtrate generated by processing the fecal matter in a pre-defined ratio with a solution of polyethylene glycol (PEG) 3350 and saline. Each 150mL dose of REBYOTA contains between 1×108 and 5×1010 colony forming units (CFU) per mL of fecal microbes including &gt;1×105 CFU/mL of Bacteroides, and contains not greater than 5.97 grams of PEG3350 in saline.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9300-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0143-9300-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9300-01) </PackageDescription>
    <NDC11Code>00143-9300-10</NDC11Code>
    <ProductNDC>0143-9300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170922</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209463</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170922</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated in adults for the following.   Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE). (1.1).   Pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome. (1.2).</IndicationAndUsage>
    <Description>The active ingredient in Pantoprazole Sodium for Injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S1.5 H2O, with a molecular weight of 432.37. The structural formula is:. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of Pantoprazole Sodium for Injection is in the pH range 9.5 to 11.5. Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile lyophilized powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), and sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-9300-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9300-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9300-11) </PackageDescription>
    <NDC11Code>00409-9300-10</NDC11Code>
    <ProductNDC>0409-9300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20141107</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090194</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0409-9300-20</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9300-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (0409-9300-21) </PackageDescription>
    <NDC11Code>00409-9300-20</NDC11Code>
    <ProductNDC>0409-9300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20141107</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090194</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropivacaine Hydrochloride Injection, USP is indicated for the production of local or regional anesthesia for surgery and for acute pain management.</IndicationAndUsage>
    <Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is administered parenterally by infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O            M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n‑octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.12 mg, 5.3 mg, 7.95 mg, or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg, or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg, or 7.1 mg of sodium chloride, respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-9300-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-9300-4) </PackageDescription>
    <NDC11Code>22840-9300-04</NDC11Code>
    <ProductNDC>22840-9300</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>3 Weed Mix</ProprietaryName>
    <NonProprietaryName>Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; XANTHIUM STRUMARIUM POLLEN</SubstanceName>
    <StrengthNumber>6666.666; 6666.666; 6666.666</StrengthNumber>
    <StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
    <Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>55566-9300-2</NDCCode><ProprietaryName>Prepopik</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>22840-9300-2</NDCCode><ProprietaryName>3 Weed Mix</ProprietaryName><NonProprietaryName>Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus</NonProprietaryName></NDC><NDC><NDCCode>39822-9300-2</NDCCode><ProprietaryName>Dehydrated Alcohol</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>68788-9300-2</NDCCode><ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName><NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName></NDC><NDC><NDCCode>55566-0302-1</NDCCode><ProprietaryName>Acthrel</ProprietaryName><NonProprietaryName>Corticorelin Ovine Triflutate</NonProprietaryName></NDC><NDC><NDCCode>55566-1050-2</NDCCode><ProprietaryName>Adstiladrin</ProprietaryName><NonProprietaryName>Nadofaragene Firadenovec-vncg</NonProprietaryName></NDC><NDC><NDCCode>55566-2100-2</NDCCode><ProprietaryName>Lysteda</ProprietaryName><NonProprietaryName>Tranexamic Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-2110-2</NDCCode><ProprietaryName>Lysteda</ProprietaryName><NonProprietaryName>Tranexamic Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-2400-0</NDCCode><ProprietaryName>Ddavp</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-3000-0</NDCCode><ProprietaryName>Stimate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-5020-1</NDCCode><ProprietaryName>Desmopressin Acetate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-5020-2</NDCCode><ProprietaryName>Desmopressin Acetate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>55566-6500-3</NDCCode><ProprietaryName>Endometrin</ProprietaryName><NonProprietaryName>Progesterone</NonProprietaryName></NDC><NDC><NDCCode>55566-6700-1</NDCCode><ProprietaryName>Clenpiq</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-6800-1</NDCCode><ProprietaryName>Clenpiq</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-6800-2</NDCCode><ProprietaryName>Clenpiq</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-7185-2</NDCCode><ProprietaryName>Repronex</ProprietaryName><NonProprietaryName>Menotropins</NonProprietaryName></NDC><NDC><NDCCode>55566-7501-2</NDCCode><ProprietaryName>Menopur</ProprietaryName><NonProprietaryName>Menotropins</NonProprietaryName></NDC><NDC><NDCCode>55566-8301-2</NDCCode><ProprietaryName>Firmagon</ProprietaryName><NonProprietaryName>Degarelix</NonProprietaryName></NDC><NDC><NDCCode>55566-8303-1</NDCCode><ProprietaryName>Firmagon</ProprietaryName><NonProprietaryName>Degarelix</NonProprietaryName></NDC><NDC><NDCCode>55566-8401-1</NDCCode><ProprietaryName>Firmagon</ProprietaryName><NonProprietaryName>Degarelix</NonProprietaryName></NDC><NDC><NDCCode>55566-8401-2</NDCCode><ProprietaryName>Firmagon</ProprietaryName><NonProprietaryName>Degarelix</NonProprietaryName></NDC><NDC><NDCCode>55566-8505-6</NDCCode><ProprietaryName>Bravelle</ProprietaryName><NonProprietaryName>Urofollitropin</NonProprietaryName></NDC><NDC><NDCCode>55566-9400-1</NDCCode><ProprietaryName>Ferring Pharmaceuticals Inc.</ProprietaryName><NonProprietaryName>Progesterone</NonProprietaryName></NDC><NDC><NDCCode>55566-9700-1</NDCCode><ProprietaryName>Prepopik</ProprietaryName><NonProprietaryName>Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>55566-9800-2</NDCCode><ProprietaryName>Rebyota</ProprietaryName><NonProprietaryName>Donor Human Stool</NonProprietaryName></NDC><NDC><NDCCode>0143-9300-10</NDCCode><ProprietaryName>Pantoprazole Sodium</ProprietaryName><NonProprietaryName>Pantoprazole Sodium</NonProprietaryName></NDC><NDC><NDCCode>0409-9300-10</NDCCode><ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0409-9300-20</NDCCode><ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>22840-9300-4</NDCCode><ProprietaryName>3 Weed Mix</ProprietaryName><NonProprietaryName>Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus</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",
      "PracticeLocationAddressCityName": "REDMOND",
      "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",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "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",
      "LastName": "PERIMAN",
      "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",
      "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": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "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",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "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",
      "OtherIdentifier3": "38080A",
      "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",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "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": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
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      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "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",
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}
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