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How to Find 69933-303-25 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "69933-303-25",
      "PackageDescription": "30 PACKAGE in 1 BAG (69933-303-25)  > 140 g in 1 PACKAGE",
      "NDC11Code": "69933-0303-25",
      "ProductNDC": "69933-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alchemy Living Sanitizing Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200507",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Pearl World Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".08",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200507",
      "SamplePackage": "N",
      "IndicationAndUsage": "■To decrease bacteria on the skin that could cause disease. ■When water, soap and towel are not available."
    },
    {
      "NDCCode": "69933-302-25",
      "PackageDescription": "30 PACKAGE in 1 BAG (69933-302-25)  > 140 g in 1 PACKAGE",
      "NDC11Code": "69933-0302-25",
      "ProductNDC": "69933-302",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alchemy Living Hand Sanitizing Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200720",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Pearl World Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".08",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200720",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses  ■To decrease bacteria on the skin that could cause disease. ■ When water, soap and towel are not available."
    },
    {
      "NDCCode": "69933-303-27",
      "PackageDescription": "75 PACKAGE in 1 BOTTLE (69933-303-27)  > 140 g in 1 PACKAGE",
      "NDC11Code": "69933-0303-27",
      "ProductNDC": "69933-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alchemy Living Sanitizing Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200507",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Pearl World Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".08",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200601",
      "SamplePackage": "N",
      "IndicationAndUsage": "■To decrease bacteria on the skin that could cause disease. ■When water, soap and towel are not available."
    },
    {
      "NDCCode": "11319-303-01",
      "PackageDescription": "25 kg in 1 DRUM (11319-303-01) ",
      "NDC11Code": "11319-0303-01",
      "ProductNDC": "11319-303",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Camphor Powder Synthetic",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20190101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Ungerer And Company",
      "SubstanceName": "CAMPHOR (SYNTHETIC)",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-JAN-19"
    },
    {
      "NDCCode": "47621-303-04",
      "PackageDescription": "25 kg in 1 DRUM (47621-303-04) ",
      "NDC11Code": "47621-0303-04",
      "ProductNDC": "47621-303",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Vardenafil",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170612",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Raks Pharma Pvt. Limited",
      "SubstanceName": "VARDENAFIL HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "12-JUN-17"
    },
    {
      "NDCCode": "52301-303-25",
      "PackageDescription": "250 TABLET in 1 BOTTLE (52301-303-25) ",
      "NDC11Code": "52301-0303-25",
      "ProductNDC": "52301-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Formula 303",
      "NonProprietaryName": "Valerian Root, Passiflora, Magnesium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900919",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Dee Cee Laboratories",
      "SubstanceName": "PASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE; VALERIAN",
      "StrengthNumber": "3; 1; 6",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2025-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19900919",
      "SamplePackage": "N",
      "IndicationAndUsage": "MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two and bedtime. TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime."
    },
    {
      "NDCCode": "54864-303-56",
      "PackageDescription": "25 kg in 1 CARTON (54864-303-56)",
      "NDC11Code": "54864-0303-56",
      "ProductNDC": "54864-303",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Isosorbide Mononitrate/lactose 350m",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19830101",
      "EndMarketingDate": "20120912",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "DOTTIKON EXCLUSIVE SYNTHESIS AG",
      "SubstanceName": "ISOSORBIDE MONONITRATE",
      "StrengthNumber": "60",
      "StrengthUnit": "kg/100kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20120912"
    },
    {
      "NDCCode": "55758-303-05",
      "PackageDescription": "5 BAG in 1 CARTON (55758-303-05)  > 25 LOZENGE in 1 BAG (55758-303-25) ",
      "NDC11Code": "55758-0303-05",
      "ProductNDC": "55758-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanatos Lozenges",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190328",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Pharmadel LLC",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "5.5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190328",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55758-303-25",
      "PackageDescription": "25 LOZENGE in 1 BAG (55758-303-25) ",
      "NDC11Code": "55758-0303-25",
      "ProductNDC": "55758-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanatos Lozenges",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190328",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Pharmadel LLC",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "5.5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190328",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "62756-303-12",
      "PackageDescription": "25 kg in 1 DRUM (62756-303-12) ",
      "NDC11Code": "62756-0303-12",
      "ProductNDC": "62756-303",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Hydroxyprogesterone Caproate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200512",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
      "SubstanceName": "HYDROXYPROGESTERONE CAPROATE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/25kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-07-09",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "12-MAY-20"
    },
    {
      "NDCCode": "65267-303-00",
      "PackageDescription": "25 kg in 1 DRUM (65267-303-00)",
      "NDC11Code": "65267-0303-00",
      "ProductNDC": "65267-303",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Risperidone",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19931229",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Janssen Pharmaceutical Sciences Unlimited Company",
      "SubstanceName": "RISPERIDONE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2017-12-20",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "67091-303-25",
      "PackageDescription": "25 LOZENGE in 1 BAG (67091-303-25) ",
      "NDC11Code": "67091-0303-25",
      "ProductNDC": "67091-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sugar Free Menthol Cough Drops",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140819",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Winco Foods",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "5.8",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140819",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses temporarily relieves. cough as may occur with a cold. occasional minor irritation and sore throat."
    },
    {
      "NDCCode": "67321-303-05",
      "PackageDescription": "25 kg in 1 DRUM (67321-303-05)",
      "NDC11Code": "67321-0303-05",
      "ProductNDC": "67321-303",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20131111",
      "EndMarketingDate": "20150217",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Zhejiang Hisoar Pharmaceutical Co., Ltd.",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20150217"
    },
    {
      "NDCCode": "69230-303-24",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69230-303-24)  / 25 CAPSULE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "69230-0303-24",
      "ProductNDC": "69230-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Cetirizine Hcl",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181231",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207235",
      "LabelerName": "Camber Consumer Care",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20181231",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat ."
    },
    {
      "NDCCode": "70262-303-25",
      "PackageDescription": "25 POUCH in 1 BOX (70262-303-25)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "70262-0303-25",
      "ProductNDC": "70262-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Midol Complete",
      "NonProprietaryName": "Acetaminophen, Caffeine, And Pyrilamine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160315",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Your Safety Company",
      "SubstanceName": "ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE",
      "StrengthNumber": "500; 60; 15",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "for the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water-weight gain, 4 headache, 5 backache, 6 muscle aches, 7 fatigue."
    },
    {
      "NDCCode": "71288-303-02",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-303-02)  > 1 mL in 1 VIAL, MULTI-DOSE (71288-303-01) ",
      "NDC11Code": "71288-0303-02",
      "ProductNDC": "71288-303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyanocobalamin",
      "NonProprietaryName": "Cyanocobalamin",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "20200924",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214390",
      "LabelerName": "Meitheal Pharmaceuticals Inc.",
      "SubstanceName": "CYANOCOBALAMIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-05-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).",
      "Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below."
    },
    {
      "NDCCode": "71288-303-92",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-303-92)  / 1 mL in 1 VIAL, MULTI-DOSE (71288-303-91) ",
      "NDC11Code": "71288-0303-92",
      "ProductNDC": "71288-303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyanocobalamin",
      "NonProprietaryName": "Cyanocobalamin",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "20200924",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214390",
      "LabelerName": "Meitheal Pharmaceuticals Inc.",
      "SubstanceName": "CYANOCOBALAMIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. : 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.",
      "Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below."
    },
    {
      "NDCCode": "75163-303-25",
      "PackageDescription": "50 CLOTH in 1 POUCH (75163-303-25) ",
      "NDC11Code": "75163-0303-25",
      "ProductNDC": "75163-303",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Alcohol Wipes",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201026",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Zhuji Jianhe Paper Co., Ltd",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "4.2",
      "StrengthUnit": "mL/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20201026",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "82393-303-17",
      "PackageDescription": "25 kg in 1 DRUM (82393-303-17) ",
      "NDC11Code": "82393-0303-17",
      "ProductNDC": "82393-303",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230601",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Pharma Source Direct, Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-12-12",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-MAY-24"
    },
    {
      "NDCCode": "0143-9683-10",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (0143-9683-10)  / 10 mL in 1 VIAL, MULTI-DOSE (0143-9683-01) ",
      "NDC11Code": "00143-9683-10",
      "ProductNDC": "0143-9683",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flumazenil",
      "NonProprietaryName": "Flumazenil",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20090323",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078527",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "FLUMAZENIL",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Benzodiazepine Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090323",
      "SamplePackage": "N",
      "IndicationAndUsage": "Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.",
      "Description": "Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure, a calculated molecular weight of 303.3, and the following structural formula. Flumazenil is a white to off-white crystalline compound with an octanol: buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. Flumazenil Injection, USP is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of flumazenil compounded with 1.8 mg of methylparaben, 0.2 mg of propylparaben, 0.9% sodium chloride, 0.01% edetate disodium, and 0.01% acetic acid; the pH is adjusted to approximately 4 with hydrochloric acid and/or, if necessary, sodium hydroxide."
    },
    {
      "NDCCode": "0143-9684-10",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10)  / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01) ",
      "NDC11Code": "00143-9684-10",
      "ProductNDC": "0143-9684",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flumazenil",
      "NonProprietaryName": "Flumazenil",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20090323",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078527",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "FLUMAZENIL",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Benzodiazepine Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090323",
      "SamplePackage": "N",
      "IndicationAndUsage": "Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.",
      "Description": "Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure, a calculated molecular weight of 303.3, and the following structural formula. Flumazenil is a white to off-white crystalline compound with an octanol: buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. Flumazenil Injection, USP is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of flumazenil compounded with 1.8 mg of methylparaben, 0.2 mg of propylparaben, 0.9% sodium chloride, 0.01% edetate disodium, and 0.01% acetic acid; the pH is adjusted to approximately 4 with hydrochloric acid and/or, if necessary, sodium hydroxide."
    },
    {
      "NDCCode": "0832-1690-11",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0832-1690-11) ",
      "NDC11Code": "00832-1690-11",
      "ProductNDC": "0832-1690",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ethacrynic Acid",
      "NonProprietaryName": "Ethacrynic Acid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200219",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212417",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "ETHACRYNIC ACID",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ethacrynic acid tablets are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome.",
      "Description": "Ethacrynic acid, USP is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid, USP is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13H 12Cl 2O 4and its structural formula is:. Ethacrynic acid tablets, USP are supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "0832-1690-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (0832-1690-30) ",
      "NDC11Code": "00832-1690-30",
      "ProductNDC": "0832-1690",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ethacrynic Acid",
      "NonProprietaryName": "Ethacrynic Acid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200219",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212417",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "ETHACRYNIC ACID",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ethacrynic acid tablets are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome.",
      "Description": "Ethacrynic acid, USP is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid, USP is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13H 12Cl 2O 4and its structural formula is:. Ethacrynic acid tablets, USP are supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "16590-303-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (16590-303-30)",
      "NDC11Code": "16590-0303-30",
      "ProductNDC": "16590-303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Liothyronine Sodium",
      "NonProprietaryName": "Liothyronine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090320",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090097",
      "LabelerName": "Stat Rx USA",
      "SubstanceName": "LIOTHYRONINE SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "1/1",
      "Pharm_Classes": "l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Thyroid hormone drugs are indicated: 1 As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema and ordinary hypothyroidism in patients of any age (pediatric patients, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary) or tertiary (hypothalamic) hypothyroidism (see WARNINGS). , 2 As pituitary thyroid-stimulating hormone (TSH) suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's) and multinodular goiter. , 3 As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. .",
      "Description": "Thyroid hormone drugs are natural or synthetic preparations containing tetraiodothyronine (T4, levothyroxine) sodium or triiodothyronine (T3, liothyronine) sodium or both. T4 and T3 are produced in the human thyroid gland by the iodination and coupling of the amino acid tyrosine. T4 contains four iodine atoms and is formed by the coupling of two molecules of diiodotyrosine (DIT). T3 contains three atoms of iodine and is formed by the coupling of one molecule of DIT with one molecule of monoiodotyrosine (MIT). Both hormones are stored in the thyroid colloid as thyroglobulin. Thyroid hormone preparations belong to two categories: (1) natural hormonal preparations derived from animal thyroid, and (2) synthetic preparations. Natural preparations include desiccated thyroid and thyroglobulin. Desiccated thyroid is derived from domesticated animals that are used for food by man (either beef or hog thyroid), and thyroglobulin is derived from thyroid glands of the hog. The United States Pharmacopeia (USP) has standardized the total iodine content of natural preparations. Thyroid USP contains not less than (NLT) 0.17 percent and not more than (NMT) 0.23 percent iodine, and thyroglobulin contains not less than (NLT) 0.7 percent of organically bound iodine. Iodine content is only an indirect indicator of true hormonal biologic activity. Liothyronine Sodium Tablets, USP contain liothyronine (L-triiodothyronine or LT3), a synthetic form of a natural thyroid hormone, and is available as the sodium salt. The structural and empirical formulas and molecular weight of liothyronine sodium are given below. Twenty-five mcg of liothyronine is equivalent to approximately 1 grain of desiccated thyroid or thyroglobulin and 0.1 mg of L-thyroxine. Each round, white Liothyronine Sodium Tablet, USP contains liothyronine sodium equivalent to liothyronine as follows: 5 mcg debossed 5 and 220; 25 mcg scored and debossed 25 and 222; 50 mcg scored and debossed 50 and 223. Inactive ingredients consist of calcium sulfate, microcrystalline cellulose, hypromellose, talc, and colloidal silicon dioxide."
    },
    {
      "NDCCode": "21695-303-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE (21695-303-10)",
      "NDC11Code": "21695-0303-10",
      "ProductNDC": "21695-303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triazolam",
      "NonProprietaryName": "Triazolam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090713",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074224",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "TRIAZOLAM",
      "StrengthNumber": ".125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Triazolam Tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). Use for more than 2 to 3 weeks requires complete reevaluation of the patient (see WARNINGS). Prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply.",
      "Description": "Triazolam tablets contain triazolam, a triazolobenzodiazepine hypnotic agent. Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α][1,4]benzodiazepine. The structural formula is represented below. Each triazolam tablet, for oral administration, contains 0.125 mg or 0.25 mg of triazolam. Inactive ingredients: 0.125 mg-corn starch, docusate sodium, lactose (anhydrous), magnesium stearate, microcrystalline cellulose; 0.25 mg-corn starch, docusate sodium, FD&C Blue No. 1, lactose (anhydrous), magnesium stearate, microcrystalline cellulose."
    },
    {
      "NDCCode": "21695-303-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (21695-303-30)",
      "NDC11Code": "21695-0303-30",
      "ProductNDC": "21695-303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triazolam",
      "NonProprietaryName": "Triazolam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090713",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074224",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "TRIAZOLAM",
      "StrengthNumber": ".125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Triazolam Tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). Use for more than 2 to 3 weeks requires complete reevaluation of the patient (see WARNINGS). Prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply.",
      "Description": "Triazolam tablets contain triazolam, a triazolobenzodiazepine hypnotic agent. Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α][1,4]benzodiazepine. The structural formula is represented below. Each triazolam tablet, for oral administration, contains 0.125 mg or 0.25 mg of triazolam. Inactive ingredients: 0.125 mg-corn starch, docusate sodium, lactose (anhydrous), magnesium stearate, microcrystalline cellulose; 0.25 mg-corn starch, docusate sodium, FD&C Blue No. 1, lactose (anhydrous), magnesium stearate, microcrystalline cellulose."
    },
    {
      "NDCCode": "25010-210-27",
      "PackageDescription": "1 VIAL in 1 CARTON (25010-210-27)  > 50 mL in 1 VIAL",
      "NDC11Code": "25010-0210-27",
      "ProductNDC": "25010-210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Edecrin",
      "NonProprietaryName": "Ethacrynate Sodium",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19670110",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016093",
      "LabelerName": "Bausch Health US, LLC",
      "SubstanceName": "ETHACRYNATE SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/50mL",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19670110",
      "SamplePackage": "N",
      "IndicationAndUsage": "EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 4.Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.",
      "Description": "Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. EDECRIN is supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Intravenous SODIUM EDECRIN (ethacrynate sodium) is a sterile freeze-dried powder and is supplied in a vial containing: 1  Ethacrynate sodium equivalent to ethacrynic acid……. 50.0 mg."
    },
    {
      "NDCCode": "25010-215-15",
      "PackageDescription": "100 TABLET in 1 BOTTLE (25010-215-15) ",
      "NDC11Code": "25010-0215-15",
      "ProductNDC": "25010-215",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Edecrin",
      "NonProprietaryName": "Ethacrynic Acid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19670110",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016092",
      "LabelerName": "Bausch Health US, LLC",
      "SubstanceName": "ETHACRYNIC ACID",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19670110",
      "SamplePackage": "N",
      "IndicationAndUsage": "EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 4.Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.",
      "Description": "Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. EDECRIN is supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Intravenous SODIUM EDECRIN (ethacrynate sodium) is a sterile freeze-dried powder and is supplied in a vial containing: 1  Ethacrynate sodium equivalent to ethacrynic acid……. 50.0 mg."
    },
    {
      "NDCCode": "27808-303-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-01) ",
      "NDC11Code": "27808-0303-01",
      "ProductNDC": "27808-303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Succinate",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207206",
      "LabelerName": "Cranbury Pharmaceuticals, LLC",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250601",
      "SamplePackage": "N",
      "Description": "Metoprolol succinate, USP, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether, and heptane. Inactive ingredients: ethylcellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide."
    },
    {
      "NDCCode": "27808-303-02",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-02) ",
      "NDC11Code": "27808-0303-02",
      "ProductNDC": "27808-303",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Succinate",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207206",
      "LabelerName": "Cranbury Pharmaceuticals, LLC",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250601",
      "SamplePackage": "N",
      "Description": "Metoprolol succinate, USP, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether, and heptane. Inactive ingredients: ethylcellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"69933-303-25","ProprietaryName":"Alchemy Living Sanitizing Wipes","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"69933-302-25","ProprietaryName":"Alchemy Living Hand Sanitizing Wipes","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"69933-303-27","ProprietaryName":"Alchemy Living Sanitizing Wipes","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"11319-303-01","NonProprietaryName":"Camphor Powder Synthetic"},{"NDCCode":"47621-303-04","NonProprietaryName":"Vardenafil"},{"NDCCode":"52301-303-25","ProprietaryName":"Formula 303","NonProprietaryName":"Valerian Root, Passiflora, Magnesium Carbonate"},{"NDCCode":"54864-303-56","NonProprietaryName":"Isosorbide Mononitrate/lactose 350m"},{"NDCCode":"55758-303-05","ProprietaryName":"Sanatos Lozenges","NonProprietaryName":"Menthol"},{"NDCCode":"55758-303-25","ProprietaryName":"Sanatos Lozenges","NonProprietaryName":"Menthol"},{"NDCCode":"62756-303-12","NonProprietaryName":"Hydroxyprogesterone Caproate"},{"NDCCode":"65267-303-00","NonProprietaryName":"Risperidone"},{"NDCCode":"67091-303-25","ProprietaryName":"Sugar Free Menthol Cough Drops","NonProprietaryName":"Menthol"},{"NDCCode":"67321-303-05","NonProprietaryName":"Clindamycin Phosphate"},{"NDCCode":"69230-303-24","ProprietaryName":"Allergy Relief","NonProprietaryName":"Cetirizine Hcl"},{"NDCCode":"70262-303-25","ProprietaryName":"Midol Complete","NonProprietaryName":"Acetaminophen, Caffeine, And Pyrilamine Maleate"},{"NDCCode":"71288-303-02","ProprietaryName":"Cyanocobalamin","NonProprietaryName":"Cyanocobalamin"},{"NDCCode":"71288-303-92","ProprietaryName":"Cyanocobalamin","NonProprietaryName":"Cyanocobalamin"},{"NDCCode":"75163-303-25","ProprietaryName":"Isopropyl Alcohol Wipes","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"82393-303-17","NonProprietaryName":"Sildenafil Citrate"},{"NDCCode":"0143-9683-10","ProprietaryName":"Flumazenil","NonProprietaryName":"Flumazenil"},{"NDCCode":"0143-9684-10","ProprietaryName":"Flumazenil","NonProprietaryName":"Flumazenil"},{"NDCCode":"0832-1690-11","ProprietaryName":"Ethacrynic Acid","NonProprietaryName":"Ethacrynic Acid"},{"NDCCode":"0832-1690-30","ProprietaryName":"Ethacrynic Acid","NonProprietaryName":"Ethacrynic Acid"},{"NDCCode":"16590-303-30","ProprietaryName":"Liothyronine Sodium","NonProprietaryName":"Liothyronine Sodium"},{"NDCCode":"21695-303-10","ProprietaryName":"Triazolam","NonProprietaryName":"Triazolam"},{"NDCCode":"21695-303-30","ProprietaryName":"Triazolam","NonProprietaryName":"Triazolam"},{"NDCCode":"25010-210-27","ProprietaryName":"Sodium Edecrin","NonProprietaryName":"Ethacrynate Sodium"},{"NDCCode":"25010-215-15","ProprietaryName":"Edecrin","NonProprietaryName":"Ethacrynic Acid"},{"NDCCode":"27808-303-01","ProprietaryName":"Metoprolol Succinate","NonProprietaryName":"Metoprolol Succinate"},{"NDCCode":"27808-303-02","ProprietaryName":"Metoprolol Succinate","NonProprietaryName":"Metoprolol Succinate"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
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    <NDCCode>69933-303-25</NDCCode>
    <PackageDescription>30 PACKAGE in 1 BAG (69933-303-25)  &gt; 140 g in 1 PACKAGE</PackageDescription>
    <NDC11Code>69933-0303-25</NDC11Code>
    <ProductNDC>69933-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alchemy Living Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200507</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Pearl World Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.08</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■To decrease bacteria on the skin that could cause disease. ■When water, soap and towel are not available.</IndicationAndUsage>
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  <NDC>
    <NDCCode>69933-302-25</NDCCode>
    <PackageDescription>30 PACKAGE in 1 BAG (69933-302-25)  &gt; 140 g in 1 PACKAGE</PackageDescription>
    <NDC11Code>69933-0302-25</NDC11Code>
    <ProductNDC>69933-302</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alchemy Living Hand Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200720</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Pearl World Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.08</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses  ■To decrease bacteria on the skin that could cause disease. ■ When water, soap and towel are not available.</IndicationAndUsage>
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  <NDC>
    <NDCCode>69933-303-27</NDCCode>
    <PackageDescription>75 PACKAGE in 1 BOTTLE (69933-303-27)  &gt; 140 g in 1 PACKAGE</PackageDescription>
    <NDC11Code>69933-0303-27</NDC11Code>
    <ProductNDC>69933-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alchemy Living Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Pearl World Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.08</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■To decrease bacteria on the skin that could cause disease. ■When water, soap and towel are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11319-303-01</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (11319-303-01) </PackageDescription>
    <NDC11Code>11319-0303-01</NDC11Code>
    <ProductNDC>11319-303</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Camphor Powder Synthetic</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Ungerer And Company</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC)</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>47621-303-04</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (47621-303-04) </PackageDescription>
    <NDC11Code>47621-0303-04</NDC11Code>
    <ProductNDC>47621-303</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Vardenafil</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Raks Pharma Pvt. Limited</LabelerName>
    <SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-JUN-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>52301-303-25</NDCCode>
    <PackageDescription>250 TABLET in 1 BOTTLE (52301-303-25) </PackageDescription>
    <NDC11Code>52301-0303-25</NDC11Code>
    <ProductNDC>52301-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Formula 303</ProprietaryName>
    <NonProprietaryName>Valerian Root, Passiflora, Magnesium Carbonate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900919</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Dee Cee Laboratories</LabelerName>
    <SubstanceName>PASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE; VALERIAN</SubstanceName>
    <StrengthNumber>3; 1; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two and bedtime. TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54864-303-56</NDCCode>
    <PackageDescription>25 kg in 1 CARTON (54864-303-56)</PackageDescription>
    <NDC11Code>54864-0303-56</NDC11Code>
    <ProductNDC>54864-303</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Isosorbide Mononitrate/lactose 350m</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19830101</StartMarketingDate>
    <EndMarketingDate>20120912</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>DOTTIKON EXCLUSIVE SYNTHESIS AG</LabelerName>
    <SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20120912</ListingRecordCertifiedThrough>
  </NDC>
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    <NDCCode>55758-303-05</NDCCode>
    <PackageDescription>5 BAG in 1 CARTON (55758-303-05)  &gt; 25 LOZENGE in 1 BAG (55758-303-25) </PackageDescription>
    <NDC11Code>55758-0303-05</NDC11Code>
    <ProductNDC>55758-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanatos Lozenges</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190328</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Pharmadel LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>5.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>55758-303-25</NDCCode>
    <PackageDescription>25 LOZENGE in 1 BAG (55758-303-25) </PackageDescription>
    <NDC11Code>55758-0303-25</NDC11Code>
    <ProductNDC>55758-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanatos Lozenges</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190328</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Pharmadel LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>5.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62756-303-12</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (62756-303-12) </PackageDescription>
    <NDC11Code>62756-0303-12</NDC11Code>
    <ProductNDC>62756-303</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Hydroxyprogesterone Caproate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200512</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
    <SubstanceName>HYDROXYPROGESTERONE CAPROATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/25kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-MAY-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65267-303-00</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (65267-303-00)</PackageDescription>
    <NDC11Code>65267-0303-00</NDC11Code>
    <ProductNDC>65267-303</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19931229</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Janssen Pharmaceutical Sciences Unlimited Company</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67091-303-25</NDCCode>
    <PackageDescription>25 LOZENGE in 1 BAG (67091-303-25) </PackageDescription>
    <NDC11Code>67091-0303-25</NDC11Code>
    <ProductNDC>67091-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sugar Free Menthol Cough Drops</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140819</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Winco Foods</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>5.8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses temporarily relieves. cough as may occur with a cold. occasional minor irritation and sore throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67321-303-05</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (67321-303-05)</PackageDescription>
    <NDC11Code>67321-0303-05</NDC11Code>
    <ProductNDC>67321-303</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20131111</StartMarketingDate>
    <EndMarketingDate>20150217</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Hisoar Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20150217</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>69230-303-24</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69230-303-24)  / 25 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>69230-0303-24</NDC11Code>
    <ProductNDC>69230-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Cetirizine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181231</StartMarketingDate>
    <EndMarketingDate>20241231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207235</ApplicationNumber>
    <LabelerName>Camber Consumer Care</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20181231</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70262-303-25</NDCCode>
    <PackageDescription>25 POUCH in 1 BOX (70262-303-25)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>70262-0303-25</NDC11Code>
    <ProductNDC>70262-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Midol Complete</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Caffeine, And Pyrilamine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160315</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Your Safety Company</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE</SubstanceName>
    <StrengthNumber>500; 60; 15</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water-weight gain, 4 headache, 5 backache, 6 muscle aches, 7 fatigue.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71288-303-02</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-303-02)  &gt; 1 mL in 1 VIAL, MULTI-DOSE (71288-303-01) </PackageDescription>
    <NDC11Code>71288-0303-02</NDC11Code>
    <ProductNDC>71288-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyanocobalamin</ProprietaryName>
    <NonProprietaryName>Cyanocobalamin</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214390</ApplicationNumber>
    <LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).</IndicationAndUsage>
    <Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below.</Description>
  </NDC>
  <NDC>
    <NDCCode>71288-303-92</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-303-92)  / 1 mL in 1 VIAL, MULTI-DOSE (71288-303-91) </PackageDescription>
    <NDC11Code>71288-0303-92</NDC11Code>
    <ProductNDC>71288-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyanocobalamin</ProprietaryName>
    <NonProprietaryName>Cyanocobalamin</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214390</ApplicationNumber>
    <LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. : 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.</IndicationAndUsage>
    <Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below.</Description>
  </NDC>
  <NDC>
    <NDCCode>75163-303-25</NDCCode>
    <PackageDescription>50 CLOTH in 1 POUCH (75163-303-25) </PackageDescription>
    <NDC11Code>75163-0303-25</NDC11Code>
    <ProductNDC>75163-303</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Alcohol Wipes</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201026</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Zhuji Jianhe Paper Co., Ltd</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>4.2</StrengthNumber>
    <StrengthUnit>mL/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82393-303-17</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (82393-303-17) </PackageDescription>
    <NDC11Code>82393-0303-17</NDC11Code>
    <ProductNDC>82393-303</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230601</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Pharma Source Direct, Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-12</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAY-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0143-9683-10</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (0143-9683-10)  / 10 mL in 1 VIAL, MULTI-DOSE (0143-9683-01) </PackageDescription>
    <NDC11Code>00143-9683-10</NDC11Code>
    <ProductNDC>0143-9683</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flumazenil</ProprietaryName>
    <NonProprietaryName>Flumazenil</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20090323</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078527</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUMAZENIL</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090323</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.</IndicationAndUsage>
    <Description>Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure, a calculated molecular weight of 303.3, and the following structural formula. Flumazenil is a white to off-white crystalline compound with an octanol: buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. Flumazenil Injection, USP is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of flumazenil compounded with 1.8 mg of methylparaben, 0.2 mg of propylparaben, 0.9% sodium chloride, 0.01% edetate disodium, and 0.01% acetic acid; the pH is adjusted to approximately 4 with hydrochloric acid and/or, if necessary, sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9684-10</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10)  / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01) </PackageDescription>
    <NDC11Code>00143-9684-10</NDC11Code>
    <ProductNDC>0143-9684</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flumazenil</ProprietaryName>
    <NonProprietaryName>Flumazenil</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20090323</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078527</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUMAZENIL</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090323</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.</IndicationAndUsage>
    <Description>Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure, a calculated molecular weight of 303.3, and the following structural formula. Flumazenil is a white to off-white crystalline compound with an octanol: buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. Flumazenil Injection, USP is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of flumazenil compounded with 1.8 mg of methylparaben, 0.2 mg of propylparaben, 0.9% sodium chloride, 0.01% edetate disodium, and 0.01% acetic acid; the pH is adjusted to approximately 4 with hydrochloric acid and/or, if necessary, sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-1690-11</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0832-1690-11) </PackageDescription>
    <NDC11Code>00832-1690-11</NDC11Code>
    <ProductNDC>0832-1690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ethacrynic Acid</ProprietaryName>
    <NonProprietaryName>Ethacrynic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200219</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212417</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>ETHACRYNIC ACID</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ethacrynic acid tablets are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome.</IndicationAndUsage>
    <Description>Ethacrynic acid, USP is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid, USP is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13H 12Cl 2O 4and its structural formula is:. Ethacrynic acid tablets, USP are supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-1690-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (0832-1690-30) </PackageDescription>
    <NDC11Code>00832-1690-30</NDC11Code>
    <ProductNDC>0832-1690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ethacrynic Acid</ProprietaryName>
    <NonProprietaryName>Ethacrynic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200219</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212417</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>ETHACRYNIC ACID</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ethacrynic acid tablets are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome.</IndicationAndUsage>
    <Description>Ethacrynic acid, USP is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid, USP is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13H 12Cl 2O 4and its structural formula is:. Ethacrynic acid tablets, USP are supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-303-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (16590-303-30)</PackageDescription>
    <NDC11Code>16590-0303-30</NDC11Code>
    <ProductNDC>16590-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Liothyronine Sodium</ProprietaryName>
    <NonProprietaryName>Liothyronine Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090097</ApplicationNumber>
    <LabelerName>Stat Rx USA</LabelerName>
    <SubstanceName>LIOTHYRONINE SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>1/1</StrengthUnit>
    <Pharm_Classes>l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Thyroid hormone drugs are indicated: 1 As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema and ordinary hypothyroidism in patients of any age (pediatric patients, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary) or tertiary (hypothalamic) hypothyroidism (see WARNINGS). , 2 As pituitary thyroid-stimulating hormone (TSH) suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's) and multinodular goiter. , 3 As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. .</IndicationAndUsage>
    <Description>Thyroid hormone drugs are natural or synthetic preparations containing tetraiodothyronine (T4, levothyroxine) sodium or triiodothyronine (T3, liothyronine) sodium or both. T4 and T3 are produced in the human thyroid gland by the iodination and coupling of the amino acid tyrosine. T4 contains four iodine atoms and is formed by the coupling of two molecules of diiodotyrosine (DIT). T3 contains three atoms of iodine and is formed by the coupling of one molecule of DIT with one molecule of monoiodotyrosine (MIT). Both hormones are stored in the thyroid colloid as thyroglobulin. Thyroid hormone preparations belong to two categories: (1) natural hormonal preparations derived from animal thyroid, and (2) synthetic preparations. Natural preparations include desiccated thyroid and thyroglobulin. Desiccated thyroid is derived from domesticated animals that are used for food by man (either beef or hog thyroid), and thyroglobulin is derived from thyroid glands of the hog. The United States Pharmacopeia (USP) has standardized the total iodine content of natural preparations. Thyroid USP contains not less than (NLT) 0.17 percent and not more than (NMT) 0.23 percent iodine, and thyroglobulin contains not less than (NLT) 0.7 percent of organically bound iodine. Iodine content is only an indirect indicator of true hormonal biologic activity. Liothyronine Sodium Tablets, USP contain liothyronine (L-triiodothyronine or LT3), a synthetic form of a natural thyroid hormone, and is available as the sodium salt. The structural and empirical formulas and molecular weight of liothyronine sodium are given below. Twenty-five mcg of liothyronine is equivalent to approximately 1 grain of desiccated thyroid or thyroglobulin and 0.1 mg of L-thyroxine. Each round, white Liothyronine Sodium Tablet, USP contains liothyronine sodium equivalent to liothyronine as follows: 5 mcg debossed 5 and 220; 25 mcg scored and debossed 25 and 222; 50 mcg scored and debossed 50 and 223. Inactive ingredients consist of calcium sulfate, microcrystalline cellulose, hypromellose, talc, and colloidal silicon dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-303-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (21695-303-10)</PackageDescription>
    <NDC11Code>21695-0303-10</NDC11Code>
    <ProductNDC>21695-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triazolam</ProprietaryName>
    <NonProprietaryName>Triazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090713</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074224</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>TRIAZOLAM</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Triazolam Tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). Use for more than 2 to 3 weeks requires complete reevaluation of the patient (see WARNINGS). Prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply.</IndicationAndUsage>
    <Description>Triazolam tablets contain triazolam, a triazolobenzodiazepine hypnotic agent. Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α][1,4]benzodiazepine. The structural formula is represented below. Each triazolam tablet, for oral administration, contains 0.125 mg or 0.25 mg of triazolam. Inactive ingredients: 0.125 mg-corn starch, docusate sodium, lactose (anhydrous), magnesium stearate, microcrystalline cellulose; 0.25 mg-corn starch, docusate sodium, FD&amp;C Blue No. 1, lactose (anhydrous), magnesium stearate, microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-303-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (21695-303-30)</PackageDescription>
    <NDC11Code>21695-0303-30</NDC11Code>
    <ProductNDC>21695-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triazolam</ProprietaryName>
    <NonProprietaryName>Triazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090713</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074224</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>TRIAZOLAM</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Triazolam Tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). Use for more than 2 to 3 weeks requires complete reevaluation of the patient (see WARNINGS). Prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply.</IndicationAndUsage>
    <Description>Triazolam tablets contain triazolam, a triazolobenzodiazepine hypnotic agent. Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α][1,4]benzodiazepine. The structural formula is represented below. Each triazolam tablet, for oral administration, contains 0.125 mg or 0.25 mg of triazolam. Inactive ingredients: 0.125 mg-corn starch, docusate sodium, lactose (anhydrous), magnesium stearate, microcrystalline cellulose; 0.25 mg-corn starch, docusate sodium, FD&amp;C Blue No. 1, lactose (anhydrous), magnesium stearate, microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>25010-210-27</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (25010-210-27)  &gt; 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25010-0210-27</NDC11Code>
    <ProductNDC>25010-210</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Edecrin</ProprietaryName>
    <NonProprietaryName>Ethacrynate Sodium</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19670110</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016093</ApplicationNumber>
    <LabelerName>Bausch Health US, LLC</LabelerName>
    <SubstanceName>ETHACRYNATE SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19670110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 4.Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.</IndicationAndUsage>
    <Description>Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. EDECRIN is supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Intravenous SODIUM EDECRIN (ethacrynate sodium) is a sterile freeze-dried powder and is supplied in a vial containing: 1  Ethacrynate sodium equivalent to ethacrynic acid……. 50.0 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>25010-215-15</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (25010-215-15) </PackageDescription>
    <NDC11Code>25010-0215-15</NDC11Code>
    <ProductNDC>25010-215</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Edecrin</ProprietaryName>
    <NonProprietaryName>Ethacrynic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19670110</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016092</ApplicationNumber>
    <LabelerName>Bausch Health US, LLC</LabelerName>
    <SubstanceName>ETHACRYNIC ACID</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19670110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 4.Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.</IndicationAndUsage>
    <Description>Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C13H12Cl2O4 and its structural formula is. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C13H11Cl2NaO4 and its structural formula is. EDECRIN is supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Intravenous SODIUM EDECRIN (ethacrynate sodium) is a sterile freeze-dried powder and is supplied in a vial containing: 1  Ethacrynate sodium equivalent to ethacrynic acid……. 50.0 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>27808-303-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-01) </PackageDescription>
    <NDC11Code>27808-0303-01</NDC11Code>
    <ProductNDC>27808-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207206</ApplicationNumber>
    <LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Metoprolol succinate, USP, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether, and heptane. Inactive ingredients: ethylcellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>27808-303-02</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-02) </PackageDescription>
    <NDC11Code>27808-0303-02</NDC11Code>
    <ProductNDC>27808-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207206</ApplicationNumber>
    <LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Metoprolol succinate, USP, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether, and heptane. Inactive ingredients: ethylcellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>69933-303-25</NDCCode><ProprietaryName>Alchemy Living Sanitizing Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>69933-302-25</NDCCode><ProprietaryName>Alchemy Living Hand Sanitizing Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>69933-303-27</NDCCode><ProprietaryName>Alchemy Living Sanitizing Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>11319-303-01</NDCCode><NonProprietaryName>Camphor Powder Synthetic</NonProprietaryName></NDC><NDC><NDCCode>47621-303-04</NDCCode><NonProprietaryName>Vardenafil</NonProprietaryName></NDC><NDC><NDCCode>52301-303-25</NDCCode><ProprietaryName>Formula 303</ProprietaryName><NonProprietaryName>Valerian Root, Passiflora, Magnesium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>54864-303-56</NDCCode><NonProprietaryName>Isosorbide Mononitrate/lactose 350m</NonProprietaryName></NDC><NDC><NDCCode>55758-303-05</NDCCode><ProprietaryName>Sanatos Lozenges</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>55758-303-25</NDCCode><ProprietaryName>Sanatos Lozenges</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>62756-303-12</NDCCode><NonProprietaryName>Hydroxyprogesterone Caproate</NonProprietaryName></NDC><NDC><NDCCode>65267-303-00</NDCCode><NonProprietaryName>Risperidone</NonProprietaryName></NDC><NDC><NDCCode>67091-303-25</NDCCode><ProprietaryName>Sugar Free Menthol Cough Drops</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>67321-303-05</NDCCode><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>69230-303-24</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Cetirizine Hcl</NonProprietaryName></NDC><NDC><NDCCode>70262-303-25</NDCCode><ProprietaryName>Midol Complete</ProprietaryName><NonProprietaryName>Acetaminophen, Caffeine, And Pyrilamine Maleate</NonProprietaryName></NDC><NDC><NDCCode>71288-303-02</NDCCode><ProprietaryName>Cyanocobalamin</ProprietaryName><NonProprietaryName>Cyanocobalamin</NonProprietaryName></NDC><NDC><NDCCode>71288-303-92</NDCCode><ProprietaryName>Cyanocobalamin</ProprietaryName><NonProprietaryName>Cyanocobalamin</NonProprietaryName></NDC><NDC><NDCCode>75163-303-25</NDCCode><ProprietaryName>Isopropyl Alcohol Wipes</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>82393-303-17</NDCCode><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>0143-9683-10</NDCCode><ProprietaryName>Flumazenil</ProprietaryName><NonProprietaryName>Flumazenil</NonProprietaryName></NDC><NDC><NDCCode>0143-9684-10</NDCCode><ProprietaryName>Flumazenil</ProprietaryName><NonProprietaryName>Flumazenil</NonProprietaryName></NDC><NDC><NDCCode>0832-1690-11</NDCCode><ProprietaryName>Ethacrynic Acid</ProprietaryName><NonProprietaryName>Ethacrynic Acid</NonProprietaryName></NDC><NDC><NDCCode>0832-1690-30</NDCCode><ProprietaryName>Ethacrynic Acid</ProprietaryName><NonProprietaryName>Ethacrynic Acid</NonProprietaryName></NDC><NDC><NDCCode>16590-303-30</NDCCode><ProprietaryName>Liothyronine Sodium</ProprietaryName><NonProprietaryName>Liothyronine Sodium</NonProprietaryName></NDC><NDC><NDCCode>21695-303-10</NDCCode><ProprietaryName>Triazolam</ProprietaryName><NonProprietaryName>Triazolam</NonProprietaryName></NDC><NDC><NDCCode>21695-303-30</NDCCode><ProprietaryName>Triazolam</ProprietaryName><NonProprietaryName>Triazolam</NonProprietaryName></NDC><NDC><NDCCode>25010-210-27</NDCCode><ProprietaryName>Sodium Edecrin</ProprietaryName><NonProprietaryName>Ethacrynate Sodium</NonProprietaryName></NDC><NDC><NDCCode>25010-215-15</NDCCode><ProprietaryName>Edecrin</ProprietaryName><NonProprietaryName>Ethacrynic Acid</NonProprietaryName></NDC><NDC><NDCCode>27808-303-01</NDCCode><ProprietaryName>Metoprolol Succinate</ProprietaryName><NonProprietaryName>Metoprolol Succinate</NonProprietaryName></NDC><NDC><NDCCode>27808-303-02</NDCCode><ProprietaryName>Metoprolol Succinate</ProprietaryName><NonProprietaryName>Metoprolol Succinate</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

            
{
  "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",
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      "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 ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

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