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How to Find 62917-065-14 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "62917-065-14",
      "PackageDescription": "397 g in 1 JAR (62917-065-14)",
      "NDC11Code": "62917-0065-14",
      "ProductNDC": "62917-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Theraplex",
      "ProprietaryNameSuffix": "Healing Emollient",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20170501",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "The Theraplex Company, LLC",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "65",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": " temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather  temporarily protects minor:  cuts  scrapes  burns."
    },
    {
      "NDCCode": "62917-065-02",
      "PackageDescription": "56.6 g in 1 JAR (62917-065-02)",
      "NDC11Code": "62917-0065-02",
      "ProductNDC": "62917-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Theraplex",
      "ProprietaryNameSuffix": "Healing Emollient",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20170501",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "The Theraplex Company, LLC",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "65",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": " temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather  temporarily protects minor:  cuts  scrapes  burns."
    },
    {
      "NDCCode": "62917-065-08",
      "PackageDescription": "226.7 g in 1 JAR (62917-065-08)",
      "NDC11Code": "62917-0065-08",
      "ProductNDC": "62917-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Theraplex",
      "ProprietaryNameSuffix": "Healing Emollient",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151023",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "The Theraplex Company, LLC",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "65",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": " temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather  temporarily protects minor:  cuts  scrapes  burns."
    },
    {
      "NDCCode": "10738-065-50",
      "PackageDescription": "1 TUBE in 1 CARTON (10738-065-50)  / 14 g in 1 TUBE (10738-065-55) ",
      "NDC11Code": "10738-0065-50",
      "ProductNDC": "10738-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triderma Bruise Defense Healing -diabetics",
      "NonProprietaryName": "Arnica Montana Flower Extract",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190830",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Genuine Virgin Aloe Corporation",
      "SubstanceName": "ARNICA MONTANA FLOWER",
      "StrengthNumber": "1.6",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190830",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls Reduces pain, swelling and discoloration from bruises."
    },
    {
      "NDCCode": "21695-065-14",
      "PackageDescription": "14 TABLET in 1 BOTTLE (21695-065-14)",
      "NDC11Code": "21695-0065-14",
      "ProductNDC": "21695-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen (nsaid)",
      "ProprietaryNameSuffix": "Pain Releiver/ Fever Reducer",
      "NonProprietaryName": "Ibuprofen (nsaid)",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071333",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "24338-065-14",
      "PackageDescription": "14 TABLET in 1 BOTTLE (24338-065-14) ",
      "NDC11Code": "24338-0065-14",
      "ProductNDC": "24338-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adthyza",
      "ProprietaryNameSuffix": "Thyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230220",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Azurity Pharmaceuticals, Inc.",
      "SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
      "StrengthNumber": "38; 9",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230220",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "ADTHYZA (thyroid tablets, USP) are indicated: 1 As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). , 2 As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.",
      "Description": "ADTHYZA (thyroid tablets, USP) ADTHYZA (thyroid tablets, USP) has not been approved by FDA as a new drug.for oral use is a natural preparation derived from porcine thyroid glands and may have a characteristic odor. ADTHYZA (thyroid tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 65 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, dextrose, mannitol, microcrystalline cellulose, and sodium starch glycolate. The structural formulas are below."
    },
    {
      "NDCCode": "51811-065-99",
      "PackageDescription": "14.7868 mL in 1 BOTTLE, PLASTIC (51811-065-99)",
      "NDC11Code": "51811-0065-99",
      "ProductNDC": "51811-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hydrating Instant Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130201",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "HANOVER PEN CORP dba HPC Global",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "10.35",
      "StrengthUnit": "mL/14.78mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cleansing gel for hands that need frequent care. Decrease bacteria on skin."
    },
    {
      "NDCCode": "65727-065-14",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (65727-065-14)",
      "NDC11Code": "65727-0065-14",
      "ProductNDC": "65727-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078034",
      "LabelerName": "Biocon Limited",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "5",
      "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 lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.",
      "Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form.  This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.  This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4­hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hypromellose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contain red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
    },
    {
      "NDCCode": "65841-065-14",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (65841-065-14) ",
      "NDC11Code": "65841-0065-14",
      "ProductNDC": "65841-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077837",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20061220",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68016-065-14",
      "PackageDescription": "50 CAPSULE in 1 BOX (68016-065-14)",
      "NDC11Code": "68016-0065-14",
      "ProductNDC": "68016-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen",
      "ProprietaryNameSuffix": "Caplet",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079129",
      "LabelerName": "Chain Drug Consortium",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-25",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "68382-065-14",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68382-065-14) ",
      "NDC11Code": "68382-0065-14",
      "ProductNDC": "68382-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077837",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20061220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch."
    },
    {
      "NDCCode": "69804-065-14",
      "PackageDescription": "28500 mg in 1 BOTTLE, DISPENSING (69804-065-14)",
      "NDC11Code": "69804-0065-14",
      "ProductNDC": "69804-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Extra Strength Scar Prevention",
      "NonProprietaryName": "Lidocaine Hcl",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170501",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "ridge properties",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1000mg",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "70934-065-14",
      "PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-14) ",
      "NDC11Code": "70934-0065-14",
      "ProductNDC": "70934-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065229",
      "LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cephalexin capsules USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:  : 1 Respiratory tract infection ( 1.1) , 2 Otitis media ( 1.2) , 3 Skin and skin structure infections ( 1.3) , 4 Bone infections ( 1.4) , 5 Genitourinary tract infections (  1.5)  .",
      "Description": "Cephalexin capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin USP equivalent to 250 mg, or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
    },
    {
      "NDCCode": "72578-065-14",
      "PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-14) ",
      "NDC11Code": "72578-0065-14",
      "ProductNDC": "72578-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranolazine",
      "NonProprietaryName": "Ranolazine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210188",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "RANOLAZINE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190910",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine extended-release tablet may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
      "Description": "Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: ferrosoferric oxide, hypromellose, iron oxide yellow, magnesium stearate, methacrylic acid copolymer type C (contains polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, polyethylene glycol, sodium hydroxide, titanium dioxide and talc. Additional inactive ingredient for the 500 mg tablets include iron oxide red."
    },
    {
      "NDCCode": "73212-065-14",
      "PackageDescription": "1000 g in 1 BOTTLE (73212-065-14) ",
      "NDC11Code": "73212-0065-14",
      "ProductNDC": "73212-065",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Liraglutide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20221201",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Qingdao Biopeptek Co., Ltd.",
      "SubstanceName": "LIRAGLUTIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-26",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-DEC-22"
    },
    {
      "NDCCode": "82868-065-14",
      "PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (82868-065-14) ",
      "NDC11Code": "82868-0065-14",
      "ProductNDC": "82868-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
      "NonProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241016",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211013",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN",
      "StrengthNumber": "75; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241016",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia colior Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsule (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsule (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (monohydrate/macrocrystals) other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsule, USP (monohydrate/macrocrystals) is a hard gelatin capsule. Each capsule contains the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals, USP and 75 mg of nitrofurantoin monohydrate, USP. The chemical name of nitrofurantoin macrocrystals,USP is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate, USP is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients:Each capsule contains carbomer homopolymer type B (carbopol 974P ), corn starch, D & C Yellow No. 10, FD & C Blue No. 1, FD & C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, magnesium stearate, mannitol, povidone K30, povidone K90, sodium lauryl sulphate, talc, and titanium dioxide. USP Dissolution Test is pending."
    },
    {
      "NDCCode": "84126-065-14",
      "PackageDescription": "14 g in 1 CYLINDER (84126-065-14) ",
      "NDC11Code": "84126-0065-14",
      "ProductNDC": "84126-065",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Old Spice Red Collection Swagger",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly (anhydrous)",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M019",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "17",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240201",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces underarm wetness."
    },
    {
      "NDCCode": "10544-065-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (10544-065-30)",
      "NDC11Code": "10544-0065-30",
      "ProductNDC": "10544-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine",
      "NonProprietaryName": "Fluoxetine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078619",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Fluoxetine capsules, USP are indicated for the treatment of. Fluoxetine capsules, USP and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
      "Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem ®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
    },
    {
      "NDCCode": "10544-065-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (10544-065-90)",
      "NDC11Code": "10544-0065-90",
      "ProductNDC": "10544-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine",
      "NonProprietaryName": "Fluoxetine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078619",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Fluoxetine capsules, USP are indicated for the treatment of. Fluoxetine capsules, USP and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
      "Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem ®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
    },
    {
      "NDCCode": "13537-603-14",
      "PackageDescription": "1 BOTTLE in 1 BOX (13537-603-14)  > 30 g in 1 BOTTLE (13537-603-13)",
      "NDC11Code": "13537-0603-14",
      "ProductNDC": "13537-603",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
      "ProprietaryNameSuffix": "(claire 4) - Beige",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140428",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".065; .024; .015",
      "StrengthUnit": "g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "14783-603-14",
      "PackageDescription": "1 BOTTLE in 1 BOX (14783-603-14)  > 30 g in 1 BOTTLE (14783-603-13)",
      "NDC11Code": "14783-0603-14",
      "ProductNDC": "14783-603",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
      "ProprietaryNameSuffix": "(claire 4) - Beige",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140428",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".065; .024; .015",
      "StrengthUnit": "g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "27808-065-02",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (27808-065-02) ",
      "NDC11Code": "27808-0065-02",
      "ProductNDC": "27808-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
      "NonProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180312",
      "EndMarketingDate": "20270301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200386",
      "LabelerName": "Cranbury Pharmaceuticals, LLC",
      "SubstanceName": "PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE",
      "StrengthNumber": "6.25; 10",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2026-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180312",
      "EndMarketingDatePackage": "20270301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.",
      "Description": "Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine. Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution contains 10 mg of codeine phosphate and 6.25 mg of promethazine hydrochloride for oral administration. Promethazine HCl and Codeine Phosphate Oral Solution has a pH between 4.8 and 5.4 and contains alcohol 8% (v/v). Promethazine HCl and Codeine Phosphate Oral Solution also contains the following inactive ingredients: anhydrous citric acid, ascorbic acid, D&C Red # 33, edetate disodium, FD&C Blue #1, methylparaben, peach-mint flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate anhydrous, sodium metabisulfite, sucrose. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4  ½ H2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2- (Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure."
    },
    {
      "NDCCode": "31722-065-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-01) ",
      "NDC11Code": "31722-0065-01",
      "ProductNDC": "31722-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluvoxamine Maleate",
      "NonProprietaryName": "Fluvoxamine Maleate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217024",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "FLUVOXAMINE MALEATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250730",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1). Efficacy was demonstrated in:    One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1) .    Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and          adolescents ( 14.1, 14.3) .    One maintenance study with IR fluvoxamine tablets ( 14.2) .",
      "Description": "Fluvoxamine maleate extended-release capsule is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as ( E)-5-Methoxy-4 (trifluoromethyl)valerophenone O-(2-aminoethyl)oxime, maleate (1:1) and has the empirical formula C 15H 21F 3N 2O 2C 4H 4O 4. Its molecular weight is 434.41. The structural formula is:. Fluvoxamine maleate USP is an white to off-white powder that is soluble in methanol, dimethyl formamide and dimethyl sulphoxide very slightly soluble in water. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ethyl cellulose, FD&C Blue No. 1, ferric oxide yellow, gelatin, hydroxypropyl cellulose, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol, ammonia solution and shellac. Fluvoxamine maleate extended-release capsules contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
    },
    {
      "NDCCode": "31722-065-30",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-30) ",
      "NDC11Code": "31722-0065-30",
      "ProductNDC": "31722-065",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluvoxamine Maleate",
      "NonProprietaryName": "Fluvoxamine Maleate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217024",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "FLUVOXAMINE MALEATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250730",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1). Efficacy was demonstrated in:    One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1) .    Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and          adolescents ( 14.1, 14.3) .    One maintenance study with IR fluvoxamine tablets ( 14.2) .",
      "Description": "Fluvoxamine maleate extended-release capsule is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as ( E)-5-Methoxy-4 (trifluoromethyl)valerophenone O-(2-aminoethyl)oxime, maleate (1:1) and has the empirical formula C 15H 21F 3N 2O 2C 4H 4O 4. Its molecular weight is 434.41. The structural formula is:. Fluvoxamine maleate USP is an white to off-white powder that is soluble in methanol, dimethyl formamide and dimethyl sulphoxide very slightly soluble in water. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ethyl cellulose, FD&C Blue No. 1, ferric oxide yellow, gelatin, hydroxypropyl cellulose, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol, ammonia solution and shellac. Fluvoxamine maleate extended-release capsules contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
    },
    {
      "NDCCode": "49281-790-20",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-790-20)  / 10 mL in 1 VIAL, MULTI-DOSE (49281-790-38) ",
      "NDC11Code": "49281-0790-20",
      "ProductNDC": "49281-790",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Typhim Vi",
      "NonProprietaryName": "Salmonella Typhi Ty2 Vi Polysaccharide Antigen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19941128",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103936",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN",
      "StrengthNumber": "25",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19941128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.",
      "Description": "Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Winthrop Industrie , for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "49281-790-51",
      "PackageDescription": "1 SYRINGE in 1 PACKAGE (49281-790-51)  / .5 mL in 1 SYRINGE (49281-790-88) ",
      "NDC11Code": "49281-0790-51",
      "ProductNDC": "49281-790",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Typhim Vi",
      "NonProprietaryName": "Salmonella Typhi Ty2 Vi Polysaccharide Antigen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19941128",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103936",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN",
      "StrengthNumber": "25",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19941128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.",
      "Description": "Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Winthrop Industrie , for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "49354-065-01",
      "PackageDescription": "1000 kg in 1 CONTAINER (49354-065-01) ",
      "NDC11Code": "49354-0065-01",
      "ProductNDC": "49354-065",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "AEROSOL, FOAM",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "HK Kolmar Canada, Inc",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "g/kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-07-14",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "01-OCT-20"
    },
    {
      "NDCCode": "50090-1493-0",
      "PackageDescription": "1 SYRINGE in 1 POUCH (50090-1493-0)  / .5 mL in 1 SYRINGE",
      "NDC11Code": "50090-1493-00",
      "ProductNDC": "50090-1493",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Typhim Vi",
      "NonProprietaryName": "Salmonella Typhi Ty2 Vi Polysaccharide Antigen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19941128",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103936",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN",
      "StrengthNumber": "25",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19941128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.",
      "Description": "Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA, for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "50090-1758-0",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 PACKAGE (50090-1758-0)  / 10 mL in 1 VIAL, MULTI-DOSE (50090-1758-9) ",
      "NDC11Code": "50090-1758-00",
      "ProductNDC": "50090-1758",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Typhim Vi",
      "NonProprietaryName": "Salmonella Typhi Ty2 Vi Polysaccharide Antigen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19941128",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103936",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN",
      "StrengthNumber": "25",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19941128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.",
      "Description": "Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA, for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "50184-6700-1",
      "PackageDescription": "14.2 g in 1 CASE (50184-6700-1)",
      "NDC11Code": "50184-6700-01",
      "ProductNDC": "50184-6700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Divine Lift Foundation Spf",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110105",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Philosophy Inc.",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "1.065; .71",
      "StrengthUnit": "g/14.2g; g/14.2g",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    }
  ]
}
                    
{"NDC":[{"NDCCode":"62917-065-14","ProprietaryName":"Theraplex","NonProprietaryName":"Petrolatum"},{"NDCCode":"62917-065-02","ProprietaryName":"Theraplex","NonProprietaryName":"Petrolatum"},{"NDCCode":"62917-065-08","ProprietaryName":"Theraplex","NonProprietaryName":"Petrolatum"},{"NDCCode":"10738-065-50","ProprietaryName":"Triderma Bruise Defense Healing -diabetics","NonProprietaryName":"Arnica Montana Flower Extract"},{"NDCCode":"21695-065-14","ProprietaryName":"Ibuprofen (nsaid)","NonProprietaryName":"Ibuprofen (nsaid)"},{"NDCCode":"24338-065-14","ProprietaryName":"Adthyza","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"51811-065-99","ProprietaryName":"Hydrating Instant Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"65727-065-14","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"65841-065-14","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"68016-065-14","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"68382-065-14","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"69804-065-14","ProprietaryName":"Extra Strength Scar Prevention","NonProprietaryName":"Lidocaine Hcl"},{"NDCCode":"70934-065-14","ProprietaryName":"Cephalexin","NonProprietaryName":"Cephalexin"},{"NDCCode":"72578-065-14","ProprietaryName":"Ranolazine","NonProprietaryName":"Ranolazine"},{"NDCCode":"73212-065-14","NonProprietaryName":"Liraglutide"},{"NDCCode":"82868-065-14","ProprietaryName":"Nitrofurantoin (monohydrate/macrocrystals)","NonProprietaryName":"Nitrofurantoin (monohydrate/macrocrystals)"},{"NDCCode":"84126-065-14","ProprietaryName":"Old Spice Red Collection Swagger","NonProprietaryName":"Aluminum Zirconium Tetrachlorohydrex Gly (anhydrous)"},{"NDCCode":"10544-065-30","ProprietaryName":"Fluoxetine","NonProprietaryName":"Fluoxetine Hydrochloride"},{"NDCCode":"10544-065-90","ProprietaryName":"Fluoxetine","NonProprietaryName":"Fluoxetine Hydrochloride"},{"NDCCode":"13537-603-14","ProprietaryName":"Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16","NonProprietaryName":"Octinoxate, Titanium Dioxide, And Zinc Oxide"},{"NDCCode":"14783-603-14","ProprietaryName":"Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16","NonProprietaryName":"Octinoxate, Titanium Dioxide, And Zinc Oxide"},{"NDCCode":"27808-065-02","ProprietaryName":"Promethazine Hydrochloride And Codeine Phosphate","NonProprietaryName":"Promethazine Hydrochloride And Codeine Phosphate"},{"NDCCode":"31722-065-01","ProprietaryName":"Fluvoxamine Maleate","NonProprietaryName":"Fluvoxamine Maleate"},{"NDCCode":"31722-065-30","ProprietaryName":"Fluvoxamine Maleate","NonProprietaryName":"Fluvoxamine Maleate"},{"NDCCode":"49281-790-20","ProprietaryName":"Typhim Vi","NonProprietaryName":"Salmonella Typhi Ty2 Vi Polysaccharide Antigen"},{"NDCCode":"49281-790-51","ProprietaryName":"Typhim Vi","NonProprietaryName":"Salmonella Typhi Ty2 Vi Polysaccharide Antigen"},{"NDCCode":"49354-065-01","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"50090-1493-0","ProprietaryName":"Typhim Vi","NonProprietaryName":"Salmonella Typhi Ty2 Vi Polysaccharide Antigen"},{"NDCCode":"50090-1758-0","ProprietaryName":"Typhim Vi","NonProprietaryName":"Salmonella Typhi Ty2 Vi Polysaccharide Antigen"},{"NDCCode":"50184-6700-1","ProprietaryName":"Divine Lift Foundation Spf","NonProprietaryName":"Octinoxate And Titanium Dioxide"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>62917-065-14</NDCCode>
    <PackageDescription>397 g in 1 JAR (62917-065-14)</PackageDescription>
    <NDC11Code>62917-0065-14</NDC11Code>
    <ProductNDC>62917-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Theraplex</ProprietaryName>
    <ProprietaryNameSuffix>Healing Emollient</ProprietaryNameSuffix>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20170501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>The Theraplex Company, LLC</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <IndicationAndUsage> temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather  temporarily protects minor:  cuts  scrapes  burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62917-065-02</NDCCode>
    <PackageDescription>56.6 g in 1 JAR (62917-065-02)</PackageDescription>
    <NDC11Code>62917-0065-02</NDC11Code>
    <ProductNDC>62917-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Theraplex</ProprietaryName>
    <ProprietaryNameSuffix>Healing Emollient</ProprietaryNameSuffix>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20170501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>The Theraplex Company, LLC</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <IndicationAndUsage> temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather  temporarily protects minor:  cuts  scrapes  burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62917-065-08</NDCCode>
    <PackageDescription>226.7 g in 1 JAR (62917-065-08)</PackageDescription>
    <NDC11Code>62917-0065-08</NDC11Code>
    <ProductNDC>62917-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Theraplex</ProprietaryName>
    <ProprietaryNameSuffix>Healing Emollient</ProprietaryNameSuffix>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151023</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>The Theraplex Company, LLC</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <IndicationAndUsage> temporarily protects and helps relieve chapped or cracked skin and lips  helps protect from the drying effects of wind and cold weather  temporarily protects minor:  cuts  scrapes  burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10738-065-50</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10738-065-50)  / 14 g in 1 TUBE (10738-065-55) </PackageDescription>
    <NDC11Code>10738-0065-50</NDC11Code>
    <ProductNDC>10738-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triderma Bruise Defense Healing -diabetics</ProprietaryName>
    <NonProprietaryName>Arnica Montana Flower Extract</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190830</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Genuine Virgin Aloe Corporation</LabelerName>
    <SubstanceName>ARNICA MONTANA FLOWER</SubstanceName>
    <StrengthNumber>1.6</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls Reduces pain, swelling and discoloration from bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21695-065-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (21695-065-14)</PackageDescription>
    <NDC11Code>21695-0065-14</NDC11Code>
    <ProductNDC>21695-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen (nsaid)</ProprietaryName>
    <ProprietaryNameSuffix>Pain Releiver/ Fever Reducer</ProprietaryNameSuffix>
    <NonProprietaryName>Ibuprofen (nsaid)</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071333</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>24338-065-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (24338-065-14) </PackageDescription>
    <NDC11Code>24338-0065-14</NDC11Code>
    <ProductNDC>24338-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adthyza</ProprietaryName>
    <ProprietaryNameSuffix>Thyroid</ProprietaryNameSuffix>
    <NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230220</StartMarketingDate>
    <EndMarketingDate>20250731</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
    <StrengthNumber>38; 9</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADTHYZA (thyroid tablets, USP) are indicated: 1 As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). , 2 As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
    <Description>ADTHYZA (thyroid tablets, USP) ADTHYZA (thyroid tablets, USP) has not been approved by FDA as a new drug.for oral use is a natural preparation derived from porcine thyroid glands and may have a characteristic odor. ADTHYZA (thyroid tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 65 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, dextrose, mannitol, microcrystalline cellulose, and sodium starch glycolate. The structural formulas are below.</Description>
  </NDC>
  <NDC>
    <NDCCode>51811-065-99</NDCCode>
    <PackageDescription>14.7868 mL in 1 BOTTLE, PLASTIC (51811-065-99)</PackageDescription>
    <NDC11Code>51811-0065-99</NDC11Code>
    <ProductNDC>51811-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hydrating Instant Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>HANOVER PEN CORP dba HPC Global</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>10.35</StrengthNumber>
    <StrengthUnit>mL/14.78mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cleansing gel for hands that need frequent care. Decrease bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65727-065-14</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (65727-065-14)</PackageDescription>
    <NDC11Code>65727-0065-14</NDC11Code>
    <ProductNDC>65727-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078034</ApplicationNumber>
    <LabelerName>Biocon Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>5</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 lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form.  This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.  This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4­hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hypromellose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contain red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65841-065-14</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65841-065-14) </PackageDescription>
    <NDC11Code>65841-0065-14</NDC11Code>
    <ProductNDC>65841-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077837</ApplicationNumber>
    <LabelerName>Zydus Lifesciences Limited</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68016-065-14</NDCCode>
    <PackageDescription>50 CAPSULE in 1 BOX (68016-065-14)</PackageDescription>
    <NDC11Code>68016-0065-14</NDC11Code>
    <ProductNDC>68016-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <ProprietaryNameSuffix>Caplet</ProprietaryNameSuffix>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079129</ApplicationNumber>
    <LabelerName>Chain Drug Consortium</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-25</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68382-065-14</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68382-065-14) </PackageDescription>
    <NDC11Code>68382-0065-14</NDC11Code>
    <ProductNDC>68382-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077837</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>69804-065-14</NDCCode>
    <PackageDescription>28500 mg in 1 BOTTLE, DISPENSING (69804-065-14)</PackageDescription>
    <NDC11Code>69804-0065-14</NDC11Code>
    <ProductNDC>69804-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Extra Strength Scar Prevention</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>ridge properties</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1000mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70934-065-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-14) </PackageDescription>
    <NDC11Code>70934-0065-14</NDC11Code>
    <ProductNDC>70934-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065229</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin capsules USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:  : 1 Respiratory tract infection ( 1.1) , 2 Otitis media ( 1.2) , 3 Skin and skin structure infections ( 1.3) , 4 Bone infections ( 1.4) , 5 Genitourinary tract infections (  1.5)  .</IndicationAndUsage>
    <Description>Cephalexin capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin USP equivalent to 250 mg, or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72578-065-14</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-14) </PackageDescription>
    <NDC11Code>72578-0065-14</NDC11Code>
    <ProductNDC>72578-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranolazine</ProprietaryName>
    <NonProprietaryName>Ranolazine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210188</ApplicationNumber>
    <LabelerName>Viona Pharmaceuticals Inc</LabelerName>
    <SubstanceName>RANOLAZINE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine extended-release tablet may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
    <Description>Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: ferrosoferric oxide, hypromellose, iron oxide yellow, magnesium stearate, methacrylic acid copolymer type C (contains polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, polyethylene glycol, sodium hydroxide, titanium dioxide and talc. Additional inactive ingredient for the 500 mg tablets include iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>73212-065-14</NDCCode>
    <PackageDescription>1000 g in 1 BOTTLE (73212-065-14) </PackageDescription>
    <NDC11Code>73212-0065-14</NDC11Code>
    <ProductNDC>73212-065</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Liraglutide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20221201</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
    <SubstanceName>LIRAGLUTIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-26</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-DEC-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>82868-065-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (82868-065-14) </PackageDescription>
    <NDC11Code>82868-0065-14</NDC11Code>
    <ProductNDC>82868-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</ProprietaryName>
    <NonProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241016</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211013</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN</SubstanceName>
    <StrengthNumber>75; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia colior Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsule (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsule (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (monohydrate/macrocrystals) other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
    <Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsule, USP (monohydrate/macrocrystals) is a hard gelatin capsule. Each capsule contains the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals, USP and 75 mg of nitrofurantoin monohydrate, USP. The chemical name of nitrofurantoin macrocrystals,USP is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate, USP is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients:Each capsule contains carbomer homopolymer type B (carbopol 974P ), corn starch, D &amp; C Yellow No. 10, FD &amp; C Blue No. 1, FD &amp; C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, magnesium stearate, mannitol, povidone K30, povidone K90, sodium lauryl sulphate, talc, and titanium dioxide. USP Dissolution Test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>84126-065-14</NDCCode>
    <PackageDescription>14 g in 1 CYLINDER (84126-065-14) </PackageDescription>
    <NDC11Code>84126-0065-14</NDC11Code>
    <ProductNDC>84126-065</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Old Spice Red Collection Swagger</ProprietaryName>
    <NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly (anhydrous)</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M019</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10544-065-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (10544-065-30)</PackageDescription>
    <NDC11Code>10544-0065-30</NDC11Code>
    <ProductNDC>10544-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078619</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Fluoxetine capsules, USP are indicated for the treatment of. Fluoxetine capsules, USP and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem ®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&amp;C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&amp;C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-065-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (10544-065-90)</PackageDescription>
    <NDC11Code>10544-0065-90</NDC11Code>
    <ProductNDC>10544-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078619</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Fluoxetine capsules, USP are indicated for the treatment of. Fluoxetine capsules, USP and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem ®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&amp;C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&amp;C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>13537-603-14</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (13537-603-14)  &gt; 30 g in 1 BOTTLE (13537-603-13)</PackageDescription>
    <NDC11Code>13537-0603-14</NDC11Code>
    <ProductNDC>13537-603</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
    <ProprietaryNameSuffix>(claire 4) - Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140428</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.065; .024; .015</StrengthNumber>
    <StrengthUnit>g/g; 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>14783-603-14</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (14783-603-14)  &gt; 30 g in 1 BOTTLE (14783-603-13)</PackageDescription>
    <NDC11Code>14783-0603-14</NDC11Code>
    <ProductNDC>14783-603</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
    <ProprietaryNameSuffix>(claire 4) - Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140428</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.065; .024; .015</StrengthNumber>
    <StrengthUnit>g/g; 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>27808-065-02</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PLASTIC (27808-065-02) </PackageDescription>
    <NDC11Code>27808-0065-02</NDC11Code>
    <ProductNDC>27808-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</ProprietaryName>
    <NonProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180312</StartMarketingDate>
    <EndMarketingDate>20270301</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200386</ApplicationNumber>
    <LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE</SubstanceName>
    <StrengthNumber>6.25; 10</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180312</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270301</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
    <Description>Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine. Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution contains 10 mg of codeine phosphate and 6.25 mg of promethazine hydrochloride for oral administration. Promethazine HCl and Codeine Phosphate Oral Solution has a pH between 4.8 and 5.4 and contains alcohol 8% (v/v). Promethazine HCl and Codeine Phosphate Oral Solution also contains the following inactive ingredients: anhydrous citric acid, ascorbic acid, D&amp;C Red # 33, edetate disodium, FD&amp;C Blue #1, methylparaben, peach-mint flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate anhydrous, sodium metabisulfite, sucrose. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4  ½ H2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2- (Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-065-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-01) </PackageDescription>
    <NDC11Code>31722-0065-01</NDC11Code>
    <ProductNDC>31722-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
    <NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217024</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1). Efficacy was demonstrated in:    One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1) .    Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and          adolescents ( 14.1, 14.3) .    One maintenance study with IR fluvoxamine tablets ( 14.2) .</IndicationAndUsage>
    <Description>Fluvoxamine maleate extended-release capsule is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as ( E)-5-Methoxy-4 (trifluoromethyl)valerophenone O-(2-aminoethyl)oxime, maleate (1:1) and has the empirical formula C 15H 21F 3N 2O 2C 4H 4O 4. Its molecular weight is 434.41. The structural formula is:. Fluvoxamine maleate USP is an white to off-white powder that is soluble in methanol, dimethyl formamide and dimethyl sulphoxide very slightly soluble in water. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ethyl cellulose, FD&amp;C Blue No. 1, ferric oxide yellow, gelatin, hydroxypropyl cellulose, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol, ammonia solution and shellac. Fluvoxamine maleate extended-release capsules contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-065-30</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-30) </PackageDescription>
    <NDC11Code>31722-0065-30</NDC11Code>
    <ProductNDC>31722-065</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
    <NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217024</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1). Efficacy was demonstrated in:    One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1) .    Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and          adolescents ( 14.1, 14.3) .    One maintenance study with IR fluvoxamine tablets ( 14.2) .</IndicationAndUsage>
    <Description>Fluvoxamine maleate extended-release capsule is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as ( E)-5-Methoxy-4 (trifluoromethyl)valerophenone O-(2-aminoethyl)oxime, maleate (1:1) and has the empirical formula C 15H 21F 3N 2O 2C 4H 4O 4. Its molecular weight is 434.41. The structural formula is:. Fluvoxamine maleate USP is an white to off-white powder that is soluble in methanol, dimethyl formamide and dimethyl sulphoxide very slightly soluble in water. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ethyl cellulose, FD&amp;C Blue No. 1, ferric oxide yellow, gelatin, hydroxypropyl cellulose, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol, ammonia solution and shellac. Fluvoxamine maleate extended-release capsules contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-790-20</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-790-20)  / 10 mL in 1 VIAL, MULTI-DOSE (49281-790-38) </PackageDescription>
    <NDC11Code>49281-0790-20</NDC11Code>
    <ProductNDC>49281-790</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Typhim Vi</ProprietaryName>
    <NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19941128</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103936</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19941128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.</IndicationAndUsage>
    <Description>Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Winthrop Industrie , for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-790-51</NDCCode>
    <PackageDescription>1 SYRINGE in 1 PACKAGE (49281-790-51)  / .5 mL in 1 SYRINGE (49281-790-88) </PackageDescription>
    <NDC11Code>49281-0790-51</NDC11Code>
    <ProductNDC>49281-790</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Typhim Vi</ProprietaryName>
    <NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19941128</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103936</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19941128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.</IndicationAndUsage>
    <Description>Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Winthrop Industrie , for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>49354-065-01</NDCCode>
    <PackageDescription>1000 kg in 1 CONTAINER (49354-065-01) </PackageDescription>
    <NDC11Code>49354-0065-01</NDC11Code>
    <ProductNDC>49354-065</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <StartMarketingDate>20201001</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>HK Kolmar Canada, Inc</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>g/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-07-14</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-OCT-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>50090-1493-0</NDCCode>
    <PackageDescription>1 SYRINGE in 1 POUCH (50090-1493-0)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>50090-1493-00</NDC11Code>
    <ProductNDC>50090-1493</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Typhim Vi</ProprietaryName>
    <NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19941128</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103936</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19941128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.</IndicationAndUsage>
    <Description>Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA, for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-1758-0</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 PACKAGE (50090-1758-0)  / 10 mL in 1 VIAL, MULTI-DOSE (50090-1758-9) </PackageDescription>
    <NDC11Code>50090-1758-00</NDC11Code>
    <ProductNDC>50090-1758</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Typhim Vi</ProprietaryName>
    <NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19941128</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103936</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19941128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.</IndicationAndUsage>
    <Description>Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA, for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>50184-6700-1</NDCCode>
    <PackageDescription>14.2 g in 1 CASE (50184-6700-1)</PackageDescription>
    <NDC11Code>50184-6700-01</NDC11Code>
    <ProductNDC>50184-6700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Divine Lift Foundation Spf</ProprietaryName>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110105</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Philosophy Inc.</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>1.065; .71</StrengthNumber>
    <StrengthUnit>g/14.2g; g/14.2g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>62917-065-14</NDCCode><ProprietaryName>Theraplex</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>62917-065-02</NDCCode><ProprietaryName>Theraplex</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>62917-065-08</NDCCode><ProprietaryName>Theraplex</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>10738-065-50</NDCCode><ProprietaryName>Triderma Bruise Defense Healing -diabetics</ProprietaryName><NonProprietaryName>Arnica Montana Flower Extract</NonProprietaryName></NDC><NDC><NDCCode>21695-065-14</NDCCode><ProprietaryName>Ibuprofen (nsaid)</ProprietaryName><NonProprietaryName>Ibuprofen (nsaid)</NonProprietaryName></NDC><NDC><NDCCode>24338-065-14</NDCCode><ProprietaryName>Adthyza</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>51811-065-99</NDCCode><ProprietaryName>Hydrating Instant Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>65727-065-14</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>65841-065-14</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>68016-065-14</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>68382-065-14</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>69804-065-14</NDCCode><ProprietaryName>Extra Strength Scar Prevention</ProprietaryName><NonProprietaryName>Lidocaine Hcl</NonProprietaryName></NDC><NDC><NDCCode>70934-065-14</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC><NDC><NDCCode>72578-065-14</NDCCode><ProprietaryName>Ranolazine</ProprietaryName><NonProprietaryName>Ranolazine</NonProprietaryName></NDC><NDC><NDCCode>73212-065-14</NDCCode><NonProprietaryName>Liraglutide</NonProprietaryName></NDC><NDC><NDCCode>82868-065-14</NDCCode><ProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</ProprietaryName><NonProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</NonProprietaryName></NDC><NDC><NDCCode>84126-065-14</NDCCode><ProprietaryName>Old Spice Red Collection Swagger</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly (anhydrous)</NonProprietaryName></NDC><NDC><NDCCode>10544-065-30</NDCCode><ProprietaryName>Fluoxetine</ProprietaryName><NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10544-065-90</NDCCode><ProprietaryName>Fluoxetine</ProprietaryName><NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>13537-603-14</NDCCode><ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>14783-603-14</NDCCode><ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>27808-065-02</NDCCode><ProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</ProprietaryName><NonProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</NonProprietaryName></NDC><NDC><NDCCode>31722-065-01</NDCCode><ProprietaryName>Fluvoxamine Maleate</ProprietaryName><NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName></NDC><NDC><NDCCode>31722-065-30</NDCCode><ProprietaryName>Fluvoxamine Maleate</ProprietaryName><NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName></NDC><NDC><NDCCode>49281-790-20</NDCCode><ProprietaryName>Typhim Vi</ProprietaryName><NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName></NDC><NDC><NDCCode>49281-790-51</NDCCode><ProprietaryName>Typhim Vi</ProprietaryName><NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName></NDC><NDC><NDCCode>49354-065-01</NDCCode><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>50090-1493-0</NDCCode><ProprietaryName>Typhim Vi</ProprietaryName><NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName></NDC><NDC><NDCCode>50090-1758-0</NDCCode><ProprietaryName>Typhim Vi</ProprietaryName><NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName></NDC><NDC><NDCCode>50184-6700-1</NDCCode><ProprietaryName>Divine Lift Foundation Spf</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "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",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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