RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "49631-178-21",
      "PackageDescription": "1 CAN in 1 BOX (49631-178-21)  / 75 g in 1 CAN",
      "NDC11Code": "49631-0178-21",
      "ProductNDC": "49631-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ohtas Isan Antacid",
      "NonProprietaryName": "Calcium Carbonate, Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001016",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "OHTA'S ISAN CO.,LTD.",
      "SubstanceName": "CALCIUM CARBONATE; SODIUM BICARBONATE",
      "StrengthNumber": "1; 1",
      "StrengthUnit": "g/g; g/g",
      "Pharm_Classes": "Alkalinizing Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20001016",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves: ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms."
    },
    {
      "NDCCode": "49631-178-11",
      "PackageDescription": "75 g in 1 CAN (49631-178-11)",
      "NDC11Code": "49631-0178-11",
      "ProductNDC": "49631-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ohtas Isan Antacid",
      "NonProprietaryName": "Calcium Carbonate, Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001016",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "OHTA'S ISAN CO., LTD",
      "SubstanceName": "CALCIUM CARBONATE; SODIUM BICARBONATE",
      "StrengthNumber": "1; 1",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "49631-178-12",
      "PackageDescription": "140 g in 1 CAN (49631-178-12)",
      "NDC11Code": "49631-0178-12",
      "ProductNDC": "49631-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ohtas Isan Antacid",
      "NonProprietaryName": "Calcium Carbonate, Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001016",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "OHTA'S ISAN CO., LTD",
      "SubstanceName": "CALCIUM CARBONATE; SODIUM BICARBONATE",
      "StrengthNumber": "1; 1",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "49631-178-13",
      "PackageDescription": "1 DOSE PACK in 1 BOX (49631-178-13)  / 16 PACKET in 1 DOSE PACK / 1.3 g in 1 PACKET",
      "NDC11Code": "49631-0178-13",
      "ProductNDC": "49631-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ohtas Isan Antacid",
      "NonProprietaryName": "Calcium Carbonate, Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "OHTA'S ISAN CO.,LTD.",
      "SubstanceName": "CALCIUM CARBONATE; SODIUM BICARBONATE",
      "StrengthNumber": "1; 1",
      "StrengthUnit": "g/g; g/g",
      "Pharm_Classes": "Alkalinizing Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170701",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves: : 1 heartburn , 2 sour stomach , 3 acid indigestion , 4 upset stomach due to these symptoms ."
    },
    {
      "NDCCode": "49631-178-22",
      "PackageDescription": "1 CAN in 1 BOX (49631-178-22)  / 140 g in 1 CAN",
      "NDC11Code": "49631-0178-22",
      "ProductNDC": "49631-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ohtas Isan Antacid",
      "NonProprietaryName": "Calcium Carbonate, Sodium Bicarbonate",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001016",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "OHTA'S ISAN CO.,LTD.",
      "SubstanceName": "CALCIUM CARBONATE; SODIUM BICARBONATE",
      "StrengthNumber": "1; 1",
      "StrengthUnit": "g/g; g/g",
      "Pharm_Classes": "Alkalinizing Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20001016",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves: ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms."
    },
    {
      "NDCCode": "17224-178-21",
      "PackageDescription": "21 TABLET in 1 BOTTLE (17224-178-21) ",
      "NDC11Code": "17224-0178-21",
      "ProductNDC": "17224-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077293",
      "LabelerName": "Calvin Scott & Co., Inc.",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-03-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired.",
      "Description": "Furosemide tablets are a diuretic which is an anthranilic acid derivative. Furosemide tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and colloidal silicon dioxide. Chemically, it is 4-chloro-N-furfuryl- 5-sulfamoylanthranilic acid. Furosemide tablets are available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows."
    },
    {
      "NDCCode": "72205-178-21",
      "PackageDescription": "21 CAPSULE in 1 BOTTLE, PLASTIC (72205-178-21) ",
      "NDC11Code": "72205-0178-21",
      "ProductNDC": "72205-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pomalidomide",
      "NonProprietaryName": "Pomalidomide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260902",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210245",
      "LabelerName": "Novadoz Pharmaceuticals LLC",
      "SubstanceName": "POMALIDOMIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thalidomide Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260902",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients:  in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).",
      "Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The empirical formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder. It is soluble in dimethylsulphoxide and practically insoluble in water. Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: magnesium stearate and pregelatinized starch. The 2 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, D&C red 28, and black ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C red 40, FD&C yellow 6, and black ink. The 4 mg capsule shell contains gelatin, titanium dioxide and black ink. The components of the black ink are: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonium solution."
    },
    {
      "NDCCode": "49631-182-11",
      "PackageDescription": "1 PACKAGE in 1 CARTON (49631-182-11)  > 40 TABLET in 1 PACKAGE",
      "NDC11Code": "49631-0182-11",
      "ProductNDC": "49631-182",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ohtas Isan Antacid",
      "NonProprietaryName": "Magnesium Aluminosilicate, Calcium Carbonate, Sodium Bicarbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001116",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "OHTA'S ISAN CO., LTD",
      "SubstanceName": "ALMASILATE; CALCIUM CARBONATE; SODIUM BICARBONATE",
      "StrengthNumber": "125; 200; 200",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "relieves: ■ heartburn ■ acid indigestion ■ sour stomach ■ upset stomach due to these symptoms."
    },
    {
      "NDCCode": "49631-212-01",
      "PackageDescription": "1 PACKAGE in 1 CARTON (49631-212-01)  > 45 TABLET in 1 PACKAGE",
      "NDC11Code": "49631-0212-01",
      "ProductNDC": "49631-212",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ohtas Isan Antacid",
      "NonProprietaryName": "Magnesium Aluminosilicate, Calcium Carbonate, Sodium Bicarbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "OHTA'S ISAN CO., LTD",
      "SubstanceName": "ALMASILATE; CALCIUM CARBONATE; SODIUM BICARBONATE",
      "StrengthNumber": "83.3; 133.3; 133.3",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "relieves: ■ heartburn ■ acid indigestion ■ sour stomach ■ upset stomach due to these symptoms."
    },
    {
      "NDCCode": "10544-178-03",
      "PackageDescription": "3 TABLET in 1 BOTTLE (10544-178-03)",
      "NDC11Code": "10544-0178-03",
      "ProductNDC": "10544-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluconazole",
      "NonProprietaryName": "Fluconazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076077",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "FLUCONAZOLE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Fluconazole Tablets USP are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing Fluconazole Tablets USP for AIDS patients with cryptococcal meningitis, please see  CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
      "Description": "Fluconazole, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-Difluoro-1′,1′-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula. C 13H 12F 2N 6O M.W. 306.27. Fluconazole, USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Tablets USP, for oral administration, contain 50, 100, 150, or 200 mg of fluconazole, USP and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc."
    },
    {
      "NDCCode": "11697-319-07",
      "PackageDescription": "178 mL in 1 BOTTLE, SPRAY (11697-319-07)",
      "NDC11Code": "11697-0319-07",
      "ProductNDC": "11697-319",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aloe Sunscreen",
      "NonProprietaryName": "Homosalate, Octisalate, Avobenzone, Ensulizole Anf Octocrylene",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100816",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Aloe Vera of America, Inc.",
      "SubstanceName": "HOMOSALATE; OCTISALATE; ENSULIZOLE; AVOBENZONE; OCTOCRYLENE",
      "StrengthNumber": "10; 5; 4; 3; 2.79",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Other information: 1 protect this product from excessive heat and direct sun."
    },
    {
      "NDCCode": "13537-178-02",
      "PackageDescription": "1 TUBE in 1 BOX (13537-178-02)  > 4 g in 1 TUBE (13537-178-01)",
      "NDC11Code": "13537-0178-02",
      "ProductNDC": "13537-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20",
      "ProprietaryNameSuffix": "(mandarine) - Orange",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161104",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".071; .16",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "21695-178-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (21695-178-30)",
      "NDC11Code": "21695-0178-30",
      "ProductNDC": "21695-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pravastatin Sodium",
      "NonProprietaryName": "Pravastatin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076939",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "PRAVASTATIN SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Therapy with pravastatin sodium tablets should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.",
      "Description": "Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α (βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C23 H35 NaO7     M.W. 446.52. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets are available for oral administration as 10 mg, 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: croscarmellose sodium, lactose monohydrate (spray dried), magnesium stearate, microcrystalline cellulose, povidone, magnesium aluminum silicate, talc."
    },
    {
      "NDCCode": "33261-178-06",
      "PackageDescription": "6 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (33261-178-06)",
      "NDC11Code": "33261-0178-06",
      "ProductNDC": "33261-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Enteric Coated Stimulant Laxative",
      "NonProprietaryName": "Bisacodyl",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110922",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "BISACODYL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses: 1 relieves occasional constipation , 2 generally produces bowel movement in 6-12 hours."
    },
    {
      "NDCCode": "33261-178-30",
      "PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (33261-178-30)",
      "NDC11Code": "33261-0178-30",
      "ProductNDC": "33261-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Enteric Coated Stimulant Laxative",
      "NonProprietaryName": "Bisacodyl",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110922",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "BISACODYL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses: 1 relieves occasional constipation , 2 generally produces bowel movement in 6-12 hours."
    },
    {
      "NDCCode": "36800-178-32",
      "PackageDescription": "936 mL in 1 BOTTLE, PLASTIC (36800-178-32)",
      "NDC11Code": "36800-0178-32",
      "ProductNDC": "36800-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topco",
      "ProprietaryNameSuffix": "Antibacterial",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "TOPCO ASSOCIATES LLC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".6",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "FOR WASHING TO DECREASE BACTERIA ON THE SKIN."
    },
    {
      "NDCCode": "37205-178-51",
      "PackageDescription": "8 PACKET in 1 CARTON (37205-178-51)  > 42.5 g in 1 PACKET",
      "NDC11Code": "37205-0178-51",
      "ProductNDC": "37205-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Soothing Bath Treatment",
      "NonProprietaryName": "Colloidal Oatmeal",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20050721",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Cardinal Health",
      "SubstanceName": "OATMEAL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "42254-178-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (42254-178-24)  > 12 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "42254-0178-24",
      "ProductNDC": "42254-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Neighbor Pharmacy Allergy",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19891015",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose . sneezing . itchy, watery eyes . itchy nose or throat . temporarily relieves these symptoms of the common cold: . runny nose . sneezing ."
    },
    {
      "NDCCode": "42507-178-08",
      "PackageDescription": "222 mL in 1 BOTTLE, PUMP (42507-178-08)",
      "NDC11Code": "42507-0178-08",
      "ProductNDC": "42507-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Foaming Antibacterial",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110609",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "HYVEE INC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "43353-178-09",
      "PackageDescription": "9000 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-09)",
      "NDC11Code": "43353-0178-09",
      "ProductNDC": "43353-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prograf",
      "NonProprietaryName": "Tacrolimus",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940408",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050708",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "TACROLIMUS",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Prograf is a calcineurin-inhibitor immunosuppressant indicated for: 1 Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3), 2 Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3), 3 Limitations of Use (1.4):∘Do not use simultaneously with cyclosporine∘Intravenous use reserved for patients who can not tolerate capsules orally ∘Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.",
      "Description": "Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform."
    },
    {
      "NDCCode": "43353-178-53",
      "PackageDescription": "60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-53)",
      "NDC11Code": "43353-0178-53",
      "ProductNDC": "43353-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prograf",
      "NonProprietaryName": "Tacrolimus",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940408",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050708",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "TACROLIMUS",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Prograf is a calcineurin-inhibitor immunosuppressant indicated for: 1 Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3), 2 Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3), 3 Limitations of Use (1.4):∘Do not use simultaneously with cyclosporine∘Intravenous use reserved for patients who can not tolerate capsules orally ∘Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.",
      "Description": "Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform."
    },
    {
      "NDCCode": "43353-178-60",
      "PackageDescription": "90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-60)",
      "NDC11Code": "43353-0178-60",
      "ProductNDC": "43353-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prograf",
      "NonProprietaryName": "Tacrolimus",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940408",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050708",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "TACROLIMUS",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Prograf is a calcineurin-inhibitor immunosuppressant indicated for: 1 Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3), 2 Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3), 3 Limitations of Use (1.4):∘Do not use simultaneously with cyclosporine∘Intravenous use reserved for patients who can not tolerate capsules orally ∘Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.",
      "Description": "Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform."
    },
    {
      "NDCCode": "43353-178-80",
      "PackageDescription": "180 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-80)",
      "NDC11Code": "43353-0178-80",
      "ProductNDC": "43353-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prograf",
      "NonProprietaryName": "Tacrolimus",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940408",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050708",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "TACROLIMUS",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Prograf is a calcineurin-inhibitor immunosuppressant indicated for: 1 Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3), 2 Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3), 3 Limitations of Use (1.4):∘Do not use simultaneously with cyclosporine∘Intravenous use reserved for patients who can not tolerate capsules orally ∘Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.",
      "Description": "Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform."
    },
    {
      "NDCCode": "43598-548-21",
      "PackageDescription": "20 VIAL in 1 CARTON (43598-548-21)  / 50 mL in 1 VIAL (43598-548-50) ",
      "NDC11Code": "43598-0548-21",
      "ProductNDC": "43598-548",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propofol Injectable Emulsion",
      "NonProprietaryName": "Propofol Injectable Emulsion",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20181115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205067",
      "LabelerName": "Dr. Reddy's Laboratories, Inc.",
      "SubstanceName": "PROPOFOL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for.  Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age.  Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age.  Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients.  Sedation for Adult Patients in Combination with Regional Anesthesia.  Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients. Limitations of Use. Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)]. Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)]. Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].",
      "Description": "Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight:178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 4.5 to 7.4. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), and benzyl alcohol (0.15%); with sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion is isotonic and has a pH of 5.5 to 7.4."
    },
    {
      "NDCCode": "50563-178-01",
      "PackageDescription": "29 mL in 1 BOTTLE (50563-178-01)",
      "NDC11Code": "50563-0178-01",
      "ProductNDC": "50563-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Angel Foodcake Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141002",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "ENCHANTE ACCESSORIES INC.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Uses. To decrease bacteria on the skin that could cause disease. Recommended for repeated use."
    },
    {
      "NDCCode": "50988-178-00",
      "PackageDescription": "289.82 mL in 1 BOTTLE, PUMP (50988-178-00)",
      "NDC11Code": "50988-0178-00",
      "ProductNDC": "50988-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming Hand Cleanser",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101201",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Jets, Sets, & Elephants Beauty Corp.",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".869",
      "StrengthUnit": "mL/289.82mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "handwashing to decrease bacteria on skin."
    },
    {
      "NDCCode": "51316-178-01",
      "PackageDescription": "325 mL in 1 BOTTLE (51316-178-01) ",
      "NDC11Code": "51316-0178-01",
      "ProductNDC": "51316-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Daily Dandruff",
      "ProprietaryNameSuffix": "Anti-dandruff",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240904",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "CVS Health",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240904",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
    },
    {
      "NDCCode": "51523-178-05",
      "PackageDescription": "1 TUBE in 1 CARTON (51523-178-05)  > 50 mL in 1 TUBE",
      "NDC11Code": "51523-0178-05",
      "ProductNDC": "51523-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Natural Sun Eco",
      "ProprietaryNameSuffix": "Calming Sensitive Sunscreen Cream Spf 40",
      "NonProprietaryName": "Zinc Oxide Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "THEFACESHOP CO., LTD.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "7.85",
      "StrengthUnit": "g/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "51879-802-66",
      "PackageDescription": "178.9 g in 1 BOTTLE (51879-802-66) ",
      "NDC11Code": "51879-0802-66",
      "ProductNDC": "51879-802",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tecnu Calagel",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190620",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Tec Laboratories Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190620",
      "SamplePackage": "N",
      "IndicationAndUsage": "for temporary relief of pain and itching associated with. minor burns sunburn minor cuts scrapes insect bites. minor skin irritations. rashes due to: poison oak poison ivy poison sumac."
    },
    {
      "NDCCode": "53033-001-02",
      "PackageDescription": "178 mL in 1 BOTTLE, PLASTIC (53033-001-02)",
      "NDC11Code": "53033-0001-02",
      "ProductNDC": "53033-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Isopropyl Rubbing Alcohol",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120824",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Pioneer Associates",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "50",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses: 1 first aid to help prevent risk of infection in:, 2 minor cuts, 3 scrapes, 4 burns."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"49631-178-21","ProprietaryName":"Ohtas Isan Antacid","NonProprietaryName":"Calcium Carbonate, Sodium Bicarbonate"},{"NDCCode":"49631-178-11","ProprietaryName":"Ohtas Isan Antacid","NonProprietaryName":"Calcium Carbonate, Sodium Bicarbonate"},{"NDCCode":"49631-178-12","ProprietaryName":"Ohtas Isan Antacid","NonProprietaryName":"Calcium Carbonate, Sodium Bicarbonate"},{"NDCCode":"49631-178-13","ProprietaryName":"Ohtas Isan Antacid","NonProprietaryName":"Calcium Carbonate, Sodium Bicarbonate"},{"NDCCode":"49631-178-22","ProprietaryName":"Ohtas Isan Antacid","NonProprietaryName":"Calcium Carbonate, Sodium Bicarbonate"},{"NDCCode":"17224-178-21","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"72205-178-21","ProprietaryName":"Pomalidomide","NonProprietaryName":"Pomalidomide"},{"NDCCode":"49631-182-11","ProprietaryName":"Ohtas Isan Antacid","NonProprietaryName":"Magnesium Aluminosilicate, Calcium Carbonate, Sodium Bicarbonate"},{"NDCCode":"49631-212-01","ProprietaryName":"Ohtas Isan Antacid","NonProprietaryName":"Magnesium Aluminosilicate, Calcium Carbonate, Sodium Bicarbonate"},{"NDCCode":"10544-178-03","ProprietaryName":"Fluconazole","NonProprietaryName":"Fluconazole"},{"NDCCode":"11697-319-07","ProprietaryName":"Aloe Sunscreen","NonProprietaryName":"Homosalate, Octisalate, Avobenzone, Ensulizole Anf Octocrylene"},{"NDCCode":"13537-178-02","ProprietaryName":"Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20","NonProprietaryName":"Octinoxate And Oxybenzone"},{"NDCCode":"21695-178-30","ProprietaryName":"Pravastatin Sodium","NonProprietaryName":"Pravastatin Sodium"},{"NDCCode":"33261-178-06","ProprietaryName":"Enteric Coated Stimulant Laxative","NonProprietaryName":"Bisacodyl"},{"NDCCode":"33261-178-30","ProprietaryName":"Enteric Coated Stimulant Laxative","NonProprietaryName":"Bisacodyl"},{"NDCCode":"36800-178-32","ProprietaryName":"Topco","NonProprietaryName":"Triclosan"},{"NDCCode":"37205-178-51","ProprietaryName":"Soothing Bath Treatment","NonProprietaryName":"Colloidal Oatmeal"},{"NDCCode":"42254-178-24","ProprietaryName":"Good Neighbor Pharmacy Allergy","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"42507-178-08","ProprietaryName":"Foaming Antibacterial","NonProprietaryName":"Triclosan"},{"NDCCode":"43353-178-09","ProprietaryName":"Prograf","NonProprietaryName":"Tacrolimus"},{"NDCCode":"43353-178-53","ProprietaryName":"Prograf","NonProprietaryName":"Tacrolimus"},{"NDCCode":"43353-178-60","ProprietaryName":"Prograf","NonProprietaryName":"Tacrolimus"},{"NDCCode":"43353-178-80","ProprietaryName":"Prograf","NonProprietaryName":"Tacrolimus"},{"NDCCode":"43598-548-21","ProprietaryName":"Propofol Injectable Emulsion","NonProprietaryName":"Propofol Injectable Emulsion"},{"NDCCode":"50563-178-01","ProprietaryName":"Angel Foodcake Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"50988-178-00","ProprietaryName":"Antibacterial Foaming Hand Cleanser","NonProprietaryName":"Triclosan"},{"NDCCode":"51316-178-01","ProprietaryName":"Cvs Daily Dandruff","NonProprietaryName":"Pyrithione Zinc"},{"NDCCode":"51523-178-05","ProprietaryName":"Natural Sun Eco","NonProprietaryName":"Zinc Oxide Cream"},{"NDCCode":"51879-802-66","ProprietaryName":"Tecnu Calagel","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"53033-001-02","ProprietaryName":"Isopropyl Rubbing Alcohol","NonProprietaryName":"Isopropyl Alcohol"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>49631-178-21</NDCCode>
    <PackageDescription>1 CAN in 1 BOX (49631-178-21)  / 75 g in 1 CAN</PackageDescription>
    <NDC11Code>49631-0178-21</NDC11Code>
    <ProductNDC>49631-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ohtas Isan Antacid</ProprietaryName>
    <NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001016</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M001</ApplicationNumber>
    <LabelerName>OHTA'S ISAN CO.,LTD.</LabelerName>
    <SubstanceName>CALCIUM CARBONATE; SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1; 1</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves: ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49631-178-11</NDCCode>
    <PackageDescription>75 g in 1 CAN (49631-178-11)</PackageDescription>
    <NDC11Code>49631-0178-11</NDC11Code>
    <ProductNDC>49631-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ohtas Isan Antacid</ProprietaryName>
    <NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001016</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>OHTA'S ISAN CO., LTD</LabelerName>
    <SubstanceName>CALCIUM CARBONATE; SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1; 1</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49631-178-12</NDCCode>
    <PackageDescription>140 g in 1 CAN (49631-178-12)</PackageDescription>
    <NDC11Code>49631-0178-12</NDC11Code>
    <ProductNDC>49631-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ohtas Isan Antacid</ProprietaryName>
    <NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001016</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>OHTA'S ISAN CO., LTD</LabelerName>
    <SubstanceName>CALCIUM CARBONATE; SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1; 1</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49631-178-13</NDCCode>
    <PackageDescription>1 DOSE PACK in 1 BOX (49631-178-13)  / 16 PACKET in 1 DOSE PACK / 1.3 g in 1 PACKET</PackageDescription>
    <NDC11Code>49631-0178-13</NDC11Code>
    <ProductNDC>49631-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ohtas Isan Antacid</ProprietaryName>
    <NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M001</ApplicationNumber>
    <LabelerName>OHTA'S ISAN CO.,LTD.</LabelerName>
    <SubstanceName>CALCIUM CARBONATE; SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1; 1</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves: : 1 heartburn , 2 sour stomach , 3 acid indigestion , 4 upset stomach due to these symptoms .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49631-178-22</NDCCode>
    <PackageDescription>1 CAN in 1 BOX (49631-178-22)  / 140 g in 1 CAN</PackageDescription>
    <NDC11Code>49631-0178-22</NDC11Code>
    <ProductNDC>49631-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ohtas Isan Antacid</ProprietaryName>
    <NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001016</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M001</ApplicationNumber>
    <LabelerName>OHTA'S ISAN CO.,LTD.</LabelerName>
    <SubstanceName>CALCIUM CARBONATE; SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1; 1</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves: ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17224-178-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (17224-178-21) </PackageDescription>
    <NDC11Code>17224-0178-21</NDC11Code>
    <ProductNDC>17224-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077293</ApplicationNumber>
    <LabelerName>Calvin Scott &amp; Co., Inc.</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
    <Description>Furosemide tablets are a diuretic which is an anthranilic acid derivative. Furosemide tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and colloidal silicon dioxide. Chemically, it is 4-chloro-N-furfuryl- 5-sulfamoylanthranilic acid. Furosemide tablets are available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-178-21</NDCCode>
    <PackageDescription>21 CAPSULE in 1 BOTTLE, PLASTIC (72205-178-21) </PackageDescription>
    <NDC11Code>72205-0178-21</NDC11Code>
    <ProductNDC>72205-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pomalidomide</ProprietaryName>
    <NonProprietaryName>Pomalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260902</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210245</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>POMALIDOMIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260902</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients:  in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
    <Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The empirical formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder. It is soluble in dimethylsulphoxide and practically insoluble in water. Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: magnesium stearate and pregelatinized starch. The 2 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 1, D&amp;C red 28, and black ink. The 3 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 1, FD&amp;C red 40, FD&amp;C yellow 6, and black ink. The 4 mg capsule shell contains gelatin, titanium dioxide and black ink. The components of the black ink are: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonium solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>49631-182-11</NDCCode>
    <PackageDescription>1 PACKAGE in 1 CARTON (49631-182-11)  &gt; 40 TABLET in 1 PACKAGE</PackageDescription>
    <NDC11Code>49631-0182-11</NDC11Code>
    <ProductNDC>49631-182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ohtas Isan Antacid</ProprietaryName>
    <NonProprietaryName>Magnesium Aluminosilicate, Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001116</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>OHTA'S ISAN CO., LTD</LabelerName>
    <SubstanceName>ALMASILATE; CALCIUM CARBONATE; SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>125; 200; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>relieves: ■ heartburn ■ acid indigestion ■ sour stomach ■ upset stomach due to these symptoms.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49631-212-01</NDCCode>
    <PackageDescription>1 PACKAGE in 1 CARTON (49631-212-01)  &gt; 45 TABLET in 1 PACKAGE</PackageDescription>
    <NDC11Code>49631-0212-01</NDC11Code>
    <ProductNDC>49631-212</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ohtas Isan Antacid</ProprietaryName>
    <NonProprietaryName>Magnesium Aluminosilicate, Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>OHTA'S ISAN CO., LTD</LabelerName>
    <SubstanceName>ALMASILATE; CALCIUM CARBONATE; SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>83.3; 133.3; 133.3</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>relieves: ■ heartburn ■ acid indigestion ■ sour stomach ■ upset stomach due to these symptoms.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10544-178-03</NDCCode>
    <PackageDescription>3 TABLET in 1 BOTTLE (10544-178-03)</PackageDescription>
    <NDC11Code>10544-0178-03</NDC11Code>
    <ProductNDC>10544-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076077</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Fluconazole Tablets USP are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing Fluconazole Tablets USP for AIDS patients with cryptococcal meningitis, please see  CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-Difluoro-1′,1′-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula. C 13H 12F 2N 6O M.W. 306.27. Fluconazole, USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Tablets USP, for oral administration, contain 50, 100, 150, or 200 mg of fluconazole, USP and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&amp;C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>11697-319-07</NDCCode>
    <PackageDescription>178 mL in 1 BOTTLE, SPRAY (11697-319-07)</PackageDescription>
    <NDC11Code>11697-0319-07</NDC11Code>
    <ProductNDC>11697-319</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aloe Sunscreen</ProprietaryName>
    <NonProprietaryName>Homosalate, Octisalate, Avobenzone, Ensulizole Anf Octocrylene</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100816</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Aloe Vera of America, Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTISALATE; ENSULIZOLE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>10; 5; 4; 3; 2.79</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Other information: 1 protect this product from excessive heat and direct sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13537-178-02</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-178-02)  &gt; 4 g in 1 TUBE (13537-178-01)</PackageDescription>
    <NDC11Code>13537-0178-02</NDC11Code>
    <ProductNDC>13537-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName>
    <ProprietaryNameSuffix>(mandarine) - Orange</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161104</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.071; .16</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21695-178-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (21695-178-30)</PackageDescription>
    <NDC11Code>21695-0178-30</NDC11Code>
    <ProductNDC>21695-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pravastatin Sodium</ProprietaryName>
    <NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076939</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with pravastatin sodium tablets should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.</IndicationAndUsage>
    <Description>Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α (βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C23 H35 NaO7     M.W. 446.52. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (&gt; 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets are available for oral administration as 10 mg, 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: croscarmellose sodium, lactose monohydrate (spray dried), magnesium stearate, microcrystalline cellulose, povidone, magnesium aluminum silicate, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-178-06</NDCCode>
    <PackageDescription>6 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (33261-178-06)</PackageDescription>
    <NDC11Code>33261-0178-06</NDC11Code>
    <ProductNDC>33261-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Enteric Coated Stimulant Laxative</ProprietaryName>
    <NonProprietaryName>Bisacodyl</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110922</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BISACODYL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses: 1 relieves occasional constipation , 2 generally produces bowel movement in 6-12 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33261-178-30</NDCCode>
    <PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (33261-178-30)</PackageDescription>
    <NDC11Code>33261-0178-30</NDC11Code>
    <ProductNDC>33261-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Enteric Coated Stimulant Laxative</ProprietaryName>
    <NonProprietaryName>Bisacodyl</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110922</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BISACODYL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses: 1 relieves occasional constipation , 2 generally produces bowel movement in 6-12 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>36800-178-32</NDCCode>
    <PackageDescription>936 mL in 1 BOTTLE, PLASTIC (36800-178-32)</PackageDescription>
    <NDC11Code>36800-0178-32</NDC11Code>
    <ProductNDC>36800-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Topco</ProprietaryName>
    <ProprietaryNameSuffix>Antibacterial</ProprietaryNameSuffix>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>FOR WASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>37205-178-51</NDCCode>
    <PackageDescription>8 PACKET in 1 CARTON (37205-178-51)  &gt; 42.5 g in 1 PACKET</PackageDescription>
    <NDC11Code>37205-0178-51</NDC11Code>
    <ProductNDC>37205-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Soothing Bath Treatment</ProprietaryName>
    <NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20050721</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Cardinal Health</LabelerName>
    <SubstanceName>OATMEAL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42254-178-24</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (42254-178-24)  &gt; 12 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>42254-0178-24</NDC11Code>
    <ProductNDC>42254-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Good Neighbor Pharmacy Allergy</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19891015</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose . sneezing . itchy, watery eyes . itchy nose or throat . temporarily relieves these symptoms of the common cold: . runny nose . sneezing .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42507-178-08</NDCCode>
    <PackageDescription>222 mL in 1 BOTTLE, PUMP (42507-178-08)</PackageDescription>
    <NDC11Code>42507-0178-08</NDC11Code>
    <ProductNDC>42507-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Foaming Antibacterial</ProprietaryName>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110609</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>HYVEE INC</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43353-178-09</NDCCode>
    <PackageDescription>9000 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-09)</PackageDescription>
    <NDC11Code>43353-0178-09</NDC11Code>
    <ProductNDC>43353-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prograf</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050708</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Prograf is a calcineurin-inhibitor immunosuppressant indicated for: 1 Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3), 2 Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3), 3 Limitations of Use (1.4):∘Do not use simultaneously with cyclosporine∘Intravenous use reserved for patients who can not tolerate capsules orally ∘Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.</IndicationAndUsage>
    <Description>Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-178-53</NDCCode>
    <PackageDescription>60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-53)</PackageDescription>
    <NDC11Code>43353-0178-53</NDC11Code>
    <ProductNDC>43353-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prograf</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050708</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Prograf is a calcineurin-inhibitor immunosuppressant indicated for: 1 Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3), 2 Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3), 3 Limitations of Use (1.4):∘Do not use simultaneously with cyclosporine∘Intravenous use reserved for patients who can not tolerate capsules orally ∘Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.</IndicationAndUsage>
    <Description>Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-178-60</NDCCode>
    <PackageDescription>90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-60)</PackageDescription>
    <NDC11Code>43353-0178-60</NDC11Code>
    <ProductNDC>43353-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prograf</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050708</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Prograf is a calcineurin-inhibitor immunosuppressant indicated for: 1 Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3), 2 Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3), 3 Limitations of Use (1.4):∘Do not use simultaneously with cyclosporine∘Intravenous use reserved for patients who can not tolerate capsules orally ∘Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.</IndicationAndUsage>
    <Description>Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-178-80</NDCCode>
    <PackageDescription>180 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-80)</PackageDescription>
    <NDC11Code>43353-0178-80</NDC11Code>
    <ProductNDC>43353-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prograf</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050708</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Prograf is a calcineurin-inhibitor immunosuppressant indicated for: 1 Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3), 2 Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3), 3 Limitations of Use (1.4):∘Do not use simultaneously with cyclosporine∘Intravenous use reserved for patients who can not tolerate capsules orally ∘Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.</IndicationAndUsage>
    <Description>Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-548-21</NDCCode>
    <PackageDescription>20 VIAL in 1 CARTON (43598-548-21)  / 50 mL in 1 VIAL (43598-548-50) </PackageDescription>
    <NDC11Code>43598-0548-21</NDC11Code>
    <ProductNDC>43598-548</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propofol Injectable Emulsion</ProprietaryName>
    <NonProprietaryName>Propofol Injectable Emulsion</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205067</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for.  Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age.  Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age.  Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients.  Sedation for Adult Patients in Combination with Regional Anesthesia.  Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients. Limitations of Use. Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)]. Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)]. Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].</IndicationAndUsage>
    <Description>Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight:178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 4.5 to 7.4. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), and benzyl alcohol (0.15%); with sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion is isotonic and has a pH of 5.5 to 7.4.</Description>
  </NDC>
  <NDC>
    <NDCCode>50563-178-01</NDCCode>
    <PackageDescription>29 mL in 1 BOTTLE (50563-178-01)</PackageDescription>
    <NDC11Code>50563-0178-01</NDC11Code>
    <ProductNDC>50563-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Angel Foodcake Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141002</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses. To decrease bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50988-178-00</NDCCode>
    <PackageDescription>289.82 mL in 1 BOTTLE, PUMP (50988-178-00)</PackageDescription>
    <NDC11Code>50988-0178-00</NDC11Code>
    <ProductNDC>50988-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Foaming Hand Cleanser</ProprietaryName>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Jets, Sets, &amp; Elephants Beauty Corp.</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.869</StrengthNumber>
    <StrengthUnit>mL/289.82mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>handwashing to decrease bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51316-178-01</NDCCode>
    <PackageDescription>325 mL in 1 BOTTLE (51316-178-01) </PackageDescription>
    <NDC11Code>51316-0178-01</NDC11Code>
    <ProductNDC>51316-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Daily Dandruff</ProprietaryName>
    <ProprietaryNameSuffix>Anti-dandruff</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240904</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>CVS Health</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240904</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51523-178-05</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51523-178-05)  &gt; 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>51523-0178-05</NDC11Code>
    <ProductNDC>51523-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Natural Sun Eco</ProprietaryName>
    <ProprietaryNameSuffix>Calming Sensitive Sunscreen Cream Spf 40</ProprietaryNameSuffix>
    <NonProprietaryName>Zinc Oxide Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>THEFACESHOP CO., LTD.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>7.85</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51879-802-66</NDCCode>
    <PackageDescription>178.9 g in 1 BOTTLE (51879-802-66) </PackageDescription>
    <NDC11Code>51879-0802-66</NDC11Code>
    <ProductNDC>51879-802</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tecnu Calagel</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190620</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Tec Laboratories Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for temporary relief of pain and itching associated with. minor burns sunburn minor cuts scrapes insect bites. minor skin irritations. rashes due to: poison oak poison ivy poison sumac.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>53033-001-02</NDCCode>
    <PackageDescription>178 mL in 1 BOTTLE, PLASTIC (53033-001-02)</PackageDescription>
    <NDC11Code>53033-0001-02</NDC11Code>
    <ProductNDC>53033-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Rubbing Alcohol</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120824</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Pioneer Associates</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses: 1 first aid to help prevent risk of infection in:, 2 minor cuts, 3 scrapes, 4 burns.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>49631-178-21</NDCCode><ProprietaryName>Ohtas Isan Antacid</ProprietaryName><NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>49631-178-11</NDCCode><ProprietaryName>Ohtas Isan Antacid</ProprietaryName><NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>49631-178-12</NDCCode><ProprietaryName>Ohtas Isan Antacid</ProprietaryName><NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>49631-178-13</NDCCode><ProprietaryName>Ohtas Isan Antacid</ProprietaryName><NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>49631-178-22</NDCCode><ProprietaryName>Ohtas Isan Antacid</ProprietaryName><NonProprietaryName>Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>17224-178-21</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>72205-178-21</NDCCode><ProprietaryName>Pomalidomide</ProprietaryName><NonProprietaryName>Pomalidomide</NonProprietaryName></NDC><NDC><NDCCode>49631-182-11</NDCCode><ProprietaryName>Ohtas Isan Antacid</ProprietaryName><NonProprietaryName>Magnesium Aluminosilicate, Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>49631-212-01</NDCCode><ProprietaryName>Ohtas Isan Antacid</ProprietaryName><NonProprietaryName>Magnesium Aluminosilicate, Calcium Carbonate, Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10544-178-03</NDCCode><ProprietaryName>Fluconazole</ProprietaryName><NonProprietaryName>Fluconazole</NonProprietaryName></NDC><NDC><NDCCode>11697-319-07</NDCCode><ProprietaryName>Aloe Sunscreen</ProprietaryName><NonProprietaryName>Homosalate, Octisalate, Avobenzone, Ensulizole Anf Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>13537-178-02</NDCCode><ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>21695-178-30</NDCCode><ProprietaryName>Pravastatin Sodium</ProprietaryName><NonProprietaryName>Pravastatin Sodium</NonProprietaryName></NDC><NDC><NDCCode>33261-178-06</NDCCode><ProprietaryName>Enteric Coated Stimulant Laxative</ProprietaryName><NonProprietaryName>Bisacodyl</NonProprietaryName></NDC><NDC><NDCCode>33261-178-30</NDCCode><ProprietaryName>Enteric Coated Stimulant Laxative</ProprietaryName><NonProprietaryName>Bisacodyl</NonProprietaryName></NDC><NDC><NDCCode>36800-178-32</NDCCode><ProprietaryName>Topco</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>37205-178-51</NDCCode><ProprietaryName>Soothing Bath Treatment</ProprietaryName><NonProprietaryName>Colloidal Oatmeal</NonProprietaryName></NDC><NDC><NDCCode>42254-178-24</NDCCode><ProprietaryName>Good Neighbor Pharmacy Allergy</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42507-178-08</NDCCode><ProprietaryName>Foaming Antibacterial</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>43353-178-09</NDCCode><ProprietaryName>Prograf</ProprietaryName><NonProprietaryName>Tacrolimus</NonProprietaryName></NDC><NDC><NDCCode>43353-178-53</NDCCode><ProprietaryName>Prograf</ProprietaryName><NonProprietaryName>Tacrolimus</NonProprietaryName></NDC><NDC><NDCCode>43353-178-60</NDCCode><ProprietaryName>Prograf</ProprietaryName><NonProprietaryName>Tacrolimus</NonProprietaryName></NDC><NDC><NDCCode>43353-178-80</NDCCode><ProprietaryName>Prograf</ProprietaryName><NonProprietaryName>Tacrolimus</NonProprietaryName></NDC><NDC><NDCCode>43598-548-21</NDCCode><ProprietaryName>Propofol Injectable Emulsion</ProprietaryName><NonProprietaryName>Propofol Injectable Emulsion</NonProprietaryName></NDC><NDC><NDCCode>50563-178-01</NDCCode><ProprietaryName>Angel Foodcake Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>50988-178-00</NDCCode><ProprietaryName>Antibacterial Foaming Hand Cleanser</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>51316-178-01</NDCCode><ProprietaryName>Cvs Daily Dandruff</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>51523-178-05</NDCCode><ProprietaryName>Natural Sun Eco</ProprietaryName><NonProprietaryName>Zinc Oxide Cream</NonProprietaryName></NDC><NDC><NDCCode>51879-802-66</NDCCode><ProprietaryName>Tecnu Calagel</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>53033-001-02</NDCCode><ProprietaryName>Isopropyl Rubbing Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
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      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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