RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (9 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0245-0872-42",
      "PackageDescription": "2 BOTTLE, PUMP in 1 CARTON (0245-0872-42)  / 60 GEL, METERED in 1 BOTTLE, PUMP (0245-0872-40) ",
      "NDC11Code": "00245-0872-42",
      "ProductNDC": "0245-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vogelxo",
      "NonProprietaryName": "Testosterone",
      "DosageFormName": "GEL, METERED",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140609",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204399",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "TESTOSTERONE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2025-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140609",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vogelxo is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.",
      "Description": "Vogelxo (testosterone) gel, for topical use is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Vogelxo provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. Vogelxo is available in unit-dose tubes, unit-dose packets, and a metered-dose pump. One 5-g or two 5-g tubes/packets of Vogelxo contains 50 mg or 100 mg of testosterone, respectively. One pump actuation dispenses 1.25 g of gel, which contains 12.5 mg of testosterone. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. Each metered-dose pump container is capable of dispensing 60 pump actuations. The active pharmacological ingredient in Vogelxo is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure. Inactive ingredients in Vogelxo are carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine."
    },
    {
      "NDCCode": "17224-872-42",
      "PackageDescription": "42 CAPSULE in 1 BOTTLE (17224-872-42) ",
      "NDC11Code": "17224-0872-42",
      "ProductNDC": "17224-872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phentermine Hydrochloride",
      "NonProprietaryName": "Phentermine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120217",
      "EndMarketingDate": "20260430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202248",
      "LabelerName": "Calvin Scott & Co., Inc.",
      "SubstanceName": "PHENTERMINE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120217",
      "EndMarketingDatePackage": "20260430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m 2, or ≥27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1,  12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
      "Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules USP is available as an oral capsule containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base). Each phentermine hydrochloride capsule contains the following inactive ingredients: starch 1500, lactose monohydrate and magnesium stearate. Phentermine hydrochloride capsules 15 mg also contain D&C yellow No. 10, FD&C red No. 3, FD&C blue No 1, FD&C red No. 40, gelatin and titanium dioxide. Phentermine hydrochloride capsules 30 mg also contain D&C yellow No. 10, FD&C red No. 3, gelatin and titanium dioxide. The imprinting ink for the capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue No. 2, FD&C red No. 40, FD &C blue No. 1, and D&C yellow No. 10."
    },
    {
      "NDCCode": "0245-0036-42",
      "PackageDescription": "42 PACKET in 1 CARTON (0245-0036-42)  / 5.5 g in 1 PACKET (0245-0036-89) ",
      "NDC11Code": "00245-0036-42",
      "ProductNDC": "0245-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevalite",
      "NonProprietaryName": "Cholestyramine",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960201",
      "EndMarketingDate": "20271031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073263",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "CHOLESTYRAMINE",
      "StrengthNumber": "4",
      "StrengthUnit": "g/5.5g",
      "Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19960201",
      "EndMarketingDatePackage": "20271031",
      "SamplePackage": "N",
      "IndicationAndUsage": "1) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ®(cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total Cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.",
      "Description": "Prevalite ®(cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ®(cholestyramine for oral suspension, USP) is not absorbed from the digestive tract. 5.5 grams of Prevalite ®(cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula:. Prevalite ®(cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor."
    },
    {
      "NDCCode": "71335-0245-1",
      "PackageDescription": "42 TABLET in 1 BOTTLE (71335-0245-1) ",
      "NDC11Code": "71335-0245-01",
      "ProductNDC": "71335-0245",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "ProprietaryNameSuffix": "Delayed Release",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091432",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20120123",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0245-0215-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (0245-0215-60)",
      "NDC11Code": "00245-0215-60",
      "ProductNDC": "0245-0215",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "B-nexa",
      "NonProprietaryName": "Pyridoxine, Folic Acid, Calcium, And Ginger",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120815",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Upsher-Smith Laboratories, Inc.",
      "SubstanceName": "PYRIDOXINE; FOLIC ACID; CALCIUM; GINGER",
      "StrengthNumber": "42; 1.22; 124.23; 100",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-10-26"
    },
    {
      "NDCCode": "62217-245-49",
      "PackageDescription": "42 mL in 1 BOTTLE (62217-245-49) ",
      "NDC11Code": "62217-0245-49",
      "ProductNDC": "62217-245",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cabana Beach Club With Manuka Honey And Essential Oils Spf 50 Sunscreen",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180530",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Fruit of the Earth, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "30; 100; 45; 80",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190509",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn  if used as directed with other sun protectino measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "0002-0872-00",
      "PackageDescription": "3 mL in 1 CARTRIDGE (0002-0872-00) ",
      "NDC11Code": "00002-0872-00",
      "ProductNDC": "0002-0872",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Insulin Lispro-aabc",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20200615",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "INSULIN LISPRO",
      "StrengthNumber": "100",
      "StrengthUnit": "[iU]/mL",
      "Status": "Unfinished",
      "LastUpdate": "2022-03-16",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "15-JUN-20"
    },
    {
      "NDCCode": "0002-0872-30",
      "PackageDescription": "30 TRAY in 1 BOX (0002-0872-30)  > 330 CARTRIDGE in 1 TRAY > 3 mL in 1 CARTRIDGE",
      "NDC11Code": "00002-0872-30",
      "ProductNDC": "0002-0872",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Insulin Lispro-aabc",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20200615",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "INSULIN LISPRO",
      "StrengthNumber": "100",
      "StrengthUnit": "[iU]/mL",
      "Status": "Unfinished",
      "LastUpdate": "2022-03-16",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "31-DEC-20"
    },
    {
      "NDCCode": "0046-0872-04",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-04)  / 4 g in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "00046-0872-04",
      "ProductNDC": "0046-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Premarin",
      "ProprietaryNameSuffix": "Vaginal",
      "NonProprietaryName": "Conjugated Estrogens",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "19781101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020216",
      "LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED",
      "StrengthNumber": ".625",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19781101",
      "SamplePackage": "N",
      "Description": "Each gram of PREMARIN (CE) vaginal cream contains 0.625 mg CE, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil. PREMARIN vaginal cream is applied intravaginally. PREMARIN vaginal cream contains a mixture of CE obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin."
    },
    {
      "NDCCode": "0046-0872-21",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-21)  / 30 g in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "00046-0872-21",
      "ProductNDC": "0046-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Premarin",
      "ProprietaryNameSuffix": "Vaginal",
      "NonProprietaryName": "Conjugated Estrogens",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "19781101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020216",
      "LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED",
      "StrengthNumber": ".625",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19781101",
      "SamplePackage": "N",
      "Description": "Each gram of PREMARIN (CE) vaginal cream contains 0.625 mg CE, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil. PREMARIN vaginal cream is applied intravaginally. PREMARIN vaginal cream contains a mixture of CE obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin."
    },
    {
      "NDCCode": "0113-0872-40",
      "PackageDescription": "354 mL in 1 BOTTLE (0113-0872-40)",
      "NDC11Code": "00113-0872-40",
      "ProductNDC": "0113-0872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Sense Night Time Cold And Flu",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130104",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "L. Perrigo Company",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "650; 30; 12.5",
      "StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-10"
    },
    {
      "NDCCode": "0121-0872-20",
      "PackageDescription": "2 CASE in 1 CASE (0121-0872-20)  > 4 TRAY in 1 CASE (0121-0872-40)  > 10 CUP in 1 TRAY (0121-0872-10)  > 10 mL in 1 CUP",
      "NDC11Code": "00121-0872-20",
      "ProductNDC": "0121-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205222",
      "LabelerName": "Pharmaceutical Associates, Inc.",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200326",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levofloxacin oral solution is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.",
      "Description": "Levofloxacin Oral Solution, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C 18H 20FN 3O 4  ½ H 2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3>Cu +2>Zn +2>Mg +2>Ca +2. Excipients and Description of Dosage Forms. Levofloxacin Oral Solution, USP. Levofloxacin Oral Solution, USP, 25 mg/mL, is a multi-use self-preserving aqueous solution of levofloxacin with pH ranging from 5.0 to 6.0. The appearance of Levofloxacin Oral Solution, USP may range from clear yellow to clear greenish-yellow. This does not adversely affect product potency. Levofloxacin Oral Solution, USP contains the following inactive ingredients: sucrose, glycerin, saccharin sodium, Magnasweet 110F, hydrochloric acid, purified water, propylene glycol, peppermint flavor, FD&C Yellow No. 6, benzoic acid, and butylated hydroxyanisole. It may also contain a solution of sodium hydroxide for pH adjustment."
    },
    {
      "NDCCode": "0121-0872-40",
      "PackageDescription": "4 TRAY in 1 CASE (0121-0872-40)  > 10 CUP in 1 TRAY (0121-0872-10)  > 10 mL in 1 CUP",
      "NDC11Code": "00121-0872-40",
      "ProductNDC": "0121-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205222",
      "LabelerName": "Pharmaceutical Associates, Inc.",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-03-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200107",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0220-0872-41",
      "PackageDescription": "15 [hp_C] in 1 TUBE (0220-0872-41) ",
      "NDC11Code": "00220-0872-41",
      "ProductNDC": "0220-0872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blatta Orientalis",
      "NonProprietaryName": "Blatta Orientalis",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19830303",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Boiron",
      "SubstanceName": "BLATTA ORIENTALIS",
      "StrengthNumber": "15",
      "StrengthUnit": "[hp_C]/15[hp_C]",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19830303",
      "SamplePackage": "N",
      "IndicationAndUsage": "Respiratory allergies*."
    },
    {
      "NDCCode": "0363-0872-40",
      "PackageDescription": "355 mL in 1 BOTTLE (0363-0872-40)",
      "NDC11Code": "00363-0872-40",
      "ProductNDC": "0363-0872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold And Flu Relief",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120807",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Walgreen Company",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "650; 30; 12.5",
      "StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-20",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0378-0872-99",
      "PackageDescription": "4 POUCH in 1 CARTON (0378-0872-99)  / 1 PATCH in 1 POUCH (0378-0872-16)  / 7 d in 1 PATCH",
      "NDC11Code": "00378-0872-99",
      "ProductNDC": "0378-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine",
      "NonProprietaryName": "Clonidine",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20130304",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076166",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "CLONIDINE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/d",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130304",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine transdermal system, USP is a transdermal system providing continuous systemic delivery of clonidine for 7 days at an approximately constant rate. Clonidine is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2-[(2,6-Dichlorophenyl)imino]imidazolidine and has the following chemical structure. Meets USP Drug Release Test 3."
    },
    {
      "NDCCode": "0555-0872-02",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0555-0872-02) ",
      "NDC11Code": "00555-0872-02",
      "ProductNDC": "0555-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961204",
      "SamplePackage": "N",
      "IndicationAndUsage": "Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.",
      "Description": "Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate."
    },
    {
      "NDCCode": "0555-0872-04",
      "PackageDescription": "500 TABLET in 1 BOTTLE (0555-0872-04) ",
      "NDC11Code": "00555-0872-04",
      "ProductNDC": "0555-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961204",
      "SamplePackage": "N",
      "IndicationAndUsage": "Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.",
      "Description": "Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate."
    },
    {
      "NDCCode": "0573-0872-08",
      "PackageDescription": "1 CYLINDER in 1 BLISTER PACK (0573-0872-08)  / 2.2 g in 1 CYLINDER",
      "NDC11Code": "00573-0872-08",
      "ProductNDC": "0573-0872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Chapstick Total Hydration Moisture Tint Very Berry",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200225",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Haleon US Holdings LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "101",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2024-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 helps prevent sunburn, 2 helps prevent and temporarily protects chafed, chapped or cracked lips."
    },
    {
      "NDCCode": "0573-0872-11",
      "PackageDescription": "1 CYLINDER in 1 CARTON (0573-0872-11)  / 2.2 g in 1 CYLINDER",
      "NDC11Code": "00573-0872-11",
      "ProductNDC": "0573-0872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Chapstick Total Hydration Moisture Tint Very Berry",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200225",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Haleon US Holdings LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "101",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2024-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200311",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 helps prevent sunburn, 2 helps prevent and temporarily protects chafed, chapped or cracked lips."
    },
    {
      "NDCCode": "0574-0872-05",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0574-0872-05)  > 5 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00574-0872-05",
      "ProductNDC": "0574-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Estradiol Valerate",
      "NonProprietaryName": "Estradiol Valerate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20100331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090920",
      "LabelerName": "Perrigo Company",
      "SubstanceName": "ESTRADIOL VALERATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0713-0872-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0872-30) ",
      "NDC11Code": "00713-0872-30",
      "ProductNDC": "0713-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azor",
      "NonProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022100",
      "LabelerName": "Cosette Pharmaceuticals, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Active",
      "LastUpdate": "2023-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.",
      "Description": "Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of Azor is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of Azor is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets)."
    },
    {
      "NDCCode": "10056-872-40",
      "PackageDescription": "355 mL in 1 BOTTLE (10056-872-40)",
      "NDC11Code": "10056-0872-40",
      "ProductNDC": "10056-872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fulton Street Market Night Time Cold And Flu",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120822",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Access Business Group LLC",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "650; 30; 12.5",
      "StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-22"
    },
    {
      "NDCCode": "10237-872-28",
      "PackageDescription": "73 g in 1 CANISTER (10237-872-28) ",
      "NDC11Code": "10237-0872-28",
      "ProductNDC": "10237-872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ultramax Invisible Solid - Cool Blast",
      "ProprietaryNameSuffix": "Antiperspirant Deodorant Cool Blast",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M019",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": ".19",
      "StrengthUnit": "g/g",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use reduces underarm perspiration."
    },
    {
      "NDCCode": "10812-872-01",
      "PackageDescription": "141 g in 1 CAN (10812-872-01)",
      "NDC11Code": "10812-0872-01",
      "ProductNDC": "10812-872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Wet Skin Swim Humidity Sweat",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf30",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101001",
      "EndMarketingDate": "20181201",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "30; 80; 40; 80; 50",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-04",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "13537-872-06",
      "PackageDescription": "1 TUBE in 1 BOX (13537-872-06)  > 4 g in 1 TUBE (13537-872-05)",
      "NDC11Code": "13537-0872-06",
      "ProductNDC": "13537-872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Effet Parfait Rouge Amplifier",
      "ProprietaryNameSuffix": "Amplifying Spf 15 (sobriete) - Brown",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140911",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": ".072",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "14141-872-01",
      "PackageDescription": "30 g in 1 TUBE (14141-872-01) ",
      "NDC11Code": "14141-0872-01",
      "ProductNDC": "14141-872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20 Dulce De Leche 260-n",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200401",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "BEL STAR S A",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "4; 2.4",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200401",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "14593-872-01",
      "PackageDescription": "15 kg in 1 DRUM (14593-872-01) ",
      "NDC11Code": "14593-0872-01",
      "ProductNDC": "14593-872",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Rizatriptan Benzoate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210722",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Emcure Pharmaceuticals Limited",
      "SubstanceName": "RIZATRIPTAN BENZOATE",
      "StrengthNumber": "15",
      "StrengthUnit": "kg/15kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-03",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "22-JUL-21"
    },
    {
      "NDCCode": "14593-872-02",
      "PackageDescription": "50 kg in 1 DRUM (14593-872-02) ",
      "NDC11Code": "14593-0872-02",
      "ProductNDC": "14593-872",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Rizatriptan Benzoate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210722",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Emcure Pharmaceuticals Limited",
      "SubstanceName": "RIZATRIPTAN BENZOATE",
      "StrengthNumber": "15",
      "StrengthUnit": "kg/15kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-03",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "22-JUL-21"
    },
    {
      "NDCCode": "14593-872-03",
      "PackageDescription": "1 kg in 1 POUCH (14593-872-03) ",
      "NDC11Code": "14593-0872-03",
      "ProductNDC": "14593-872",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Rizatriptan Benzoate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210722",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Emcure Pharmaceuticals Limited",
      "SubstanceName": "RIZATRIPTAN BENZOATE",
      "StrengthNumber": "15",
      "StrengthUnit": "kg/15kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-03",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "22-JUL-21"
    }
  ]
}
                    

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<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>0245-0872-42</NDCCode>
    <PackageDescription>2 BOTTLE, PUMP in 1 CARTON (0245-0872-42)  / 60 GEL, METERED in 1 BOTTLE, PUMP (0245-0872-40) </PackageDescription>
    <NDC11Code>00245-0872-42</NDC11Code>
    <ProductNDC>0245-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vogelxo</ProprietaryName>
    <NonProprietaryName>Testosterone</NonProprietaryName>
    <DosageFormName>GEL, METERED</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140609</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204399</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>TESTOSTERONE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140609</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vogelxo is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.</IndicationAndUsage>
    <Description>Vogelxo (testosterone) gel, for topical use is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Vogelxo provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. Vogelxo is available in unit-dose tubes, unit-dose packets, and a metered-dose pump. One 5-g or two 5-g tubes/packets of Vogelxo contains 50 mg or 100 mg of testosterone, respectively. One pump actuation dispenses 1.25 g of gel, which contains 12.5 mg of testosterone. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. Each metered-dose pump container is capable of dispensing 60 pump actuations. The active pharmacological ingredient in Vogelxo is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure. Inactive ingredients in Vogelxo are carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine.</Description>
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  <NDC>
    <NDCCode>17224-872-42</NDCCode>
    <PackageDescription>42 CAPSULE in 1 BOTTLE (17224-872-42) </PackageDescription>
    <NDC11Code>17224-0872-42</NDC11Code>
    <ProductNDC>17224-872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120217</StartMarketingDate>
    <EndMarketingDate>20260430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202248</ApplicationNumber>
    <LabelerName>Calvin Scott &amp; Co., Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120217</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m 2, or ≥27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1,  12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules USP is available as an oral capsule containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base). Each phentermine hydrochloride capsule contains the following inactive ingredients: starch 1500, lactose monohydrate and magnesium stearate. Phentermine hydrochloride capsules 15 mg also contain D&amp;C yellow No. 10, FD&amp;C red No. 3, FD&amp;C blue No 1, FD&amp;C red No. 40, gelatin and titanium dioxide. Phentermine hydrochloride capsules 30 mg also contain D&amp;C yellow No. 10, FD&amp;C red No. 3, gelatin and titanium dioxide. The imprinting ink for the capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&amp;C blue No. 2, FD&amp;C red No. 40, FD &amp;C blue No. 1, and D&amp;C yellow No. 10.</Description>
  </NDC>
  <NDC>
    <NDCCode>0245-0036-42</NDCCode>
    <PackageDescription>42 PACKET in 1 CARTON (0245-0036-42)  / 5.5 g in 1 PACKET (0245-0036-89) </PackageDescription>
    <NDC11Code>00245-0036-42</NDC11Code>
    <ProductNDC>0245-0036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevalite</ProprietaryName>
    <NonProprietaryName>Cholestyramine</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960201</StartMarketingDate>
    <EndMarketingDate>20271031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073263</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>CHOLESTYRAMINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>g/5.5g</StrengthUnit>
    <Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19960201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20271031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ®(cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (&lt;4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total Cholesterol - [(TG/5) + HDL-C]. For TG levels &gt; 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Prevalite ®(cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.</IndicationAndUsage>
    <Description>Prevalite ®(cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ®(cholestyramine for oral suspension, USP) is not absorbed from the digestive tract. 5.5 grams of Prevalite ®(cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula:. Prevalite ®(cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&amp;C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor.</Description>
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  <NDC>
    <NDCCode>71335-0245-1</NDCCode>
    <PackageDescription>42 TABLET in 1 BOTTLE (71335-0245-1) </PackageDescription>
    <NDC11Code>71335-0245-01</NDC11Code>
    <ProductNDC>71335-0245</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091432</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0245-0215-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (0245-0215-60)</PackageDescription>
    <NDC11Code>00245-0215-60</NDC11Code>
    <ProductNDC>0245-0215</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>B-nexa</ProprietaryName>
    <NonProprietaryName>Pyridoxine, Folic Acid, Calcium, And Ginger</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
    <SubstanceName>PYRIDOXINE; FOLIC ACID; CALCIUM; GINGER</SubstanceName>
    <StrengthNumber>42; 1.22; 124.23; 100</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-10-26</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>62217-245-49</NDCCode>
    <PackageDescription>42 mL in 1 BOTTLE (62217-245-49) </PackageDescription>
    <NDC11Code>62217-0245-49</NDC11Code>
    <ProductNDC>62217-245</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cabana Beach Club With Manuka Honey And Essential Oils Spf 50 Sunscreen</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180530</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Fruit of the Earth, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 100; 45; 80</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190509</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> helps prevent sunburn  if used as directed with other sun protectino measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0002-0872-00</NDCCode>
    <PackageDescription>3 mL in 1 CARTRIDGE (0002-0872-00) </PackageDescription>
    <NDC11Code>00002-0872-00</NDC11Code>
    <ProductNDC>0002-0872</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20200615</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>INSULIN LISPRO</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-03-16</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-JUN-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0002-0872-30</NDCCode>
    <PackageDescription>30 TRAY in 1 BOX (0002-0872-30)  &gt; 330 CARTRIDGE in 1 TRAY &gt; 3 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>00002-0872-30</NDC11Code>
    <ProductNDC>0002-0872</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20200615</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>INSULIN LISPRO</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-03-16</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-DEC-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0046-0872-04</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-04)  / 4 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>00046-0872-04</NDC11Code>
    <ProductNDC>0046-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Premarin</ProprietaryName>
    <ProprietaryNameSuffix>Vaginal</ProprietaryNameSuffix>
    <NonProprietaryName>Conjugated Estrogens</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>19781101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020216</ApplicationNumber>
    <LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
    <SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
    <StrengthNumber>.625</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19781101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Each gram of PREMARIN (CE) vaginal cream contains 0.625 mg CE, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil. PREMARIN vaginal cream is applied intravaginally. PREMARIN vaginal cream contains a mixture of CE obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0046-0872-21</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-21)  / 30 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>00046-0872-21</NDC11Code>
    <ProductNDC>0046-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Premarin</ProprietaryName>
    <ProprietaryNameSuffix>Vaginal</ProprietaryNameSuffix>
    <NonProprietaryName>Conjugated Estrogens</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>19781101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020216</ApplicationNumber>
    <LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
    <SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
    <StrengthNumber>.625</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19781101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Each gram of PREMARIN (CE) vaginal cream contains 0.625 mg CE, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil. PREMARIN vaginal cream is applied intravaginally. PREMARIN vaginal cream contains a mixture of CE obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0113-0872-40</NDCCode>
    <PackageDescription>354 mL in 1 BOTTLE (0113-0872-40)</PackageDescription>
    <NDC11Code>00113-0872-40</NDC11Code>
    <ProductNDC>0113-0872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Good Sense Night Time Cold And Flu</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130104</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>L. Perrigo Company</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
    <StrengthNumber>650; 30; 12.5</StrengthNumber>
    <StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-10</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0121-0872-20</NDCCode>
    <PackageDescription>2 CASE in 1 CASE (0121-0872-20)  &gt; 4 TRAY in 1 CASE (0121-0872-40)  &gt; 10 CUP in 1 TRAY (0121-0872-10)  &gt; 10 mL in 1 CUP</PackageDescription>
    <NDC11Code>00121-0872-20</NDC11Code>
    <ProductNDC>0121-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205222</ApplicationNumber>
    <LabelerName>Pharmaceutical Associates, Inc.</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levofloxacin oral solution is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.</IndicationAndUsage>
    <Description>Levofloxacin Oral Solution, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C 18H 20FN 3O 4  ½ H 2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3&gt;Cu +2&gt;Zn +2&gt;Mg +2&gt;Ca +2. Excipients and Description of Dosage Forms. Levofloxacin Oral Solution, USP. Levofloxacin Oral Solution, USP, 25 mg/mL, is a multi-use self-preserving aqueous solution of levofloxacin with pH ranging from 5.0 to 6.0. The appearance of Levofloxacin Oral Solution, USP may range from clear yellow to clear greenish-yellow. This does not adversely affect product potency. Levofloxacin Oral Solution, USP contains the following inactive ingredients: sucrose, glycerin, saccharin sodium, Magnasweet 110F, hydrochloric acid, purified water, propylene glycol, peppermint flavor, FD&amp;C Yellow No. 6, benzoic acid, and butylated hydroxyanisole. It may also contain a solution of sodium hydroxide for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>0121-0872-40</NDCCode>
    <PackageDescription>4 TRAY in 1 CASE (0121-0872-40)  &gt; 10 CUP in 1 TRAY (0121-0872-10)  &gt; 10 mL in 1 CUP</PackageDescription>
    <NDC11Code>00121-0872-40</NDC11Code>
    <ProductNDC>0121-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205222</ApplicationNumber>
    <LabelerName>Pharmaceutical Associates, Inc.</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0220-0872-41</NDCCode>
    <PackageDescription>15 [hp_C] in 1 TUBE (0220-0872-41) </PackageDescription>
    <NDC11Code>00220-0872-41</NDC11Code>
    <ProductNDC>0220-0872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Blatta Orientalis</ProprietaryName>
    <NonProprietaryName>Blatta Orientalis</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19830303</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Boiron</LabelerName>
    <SubstanceName>BLATTA ORIENTALIS</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>[hp_C]/15[hp_C]</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19830303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Respiratory allergies*.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0363-0872-40</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (0363-0872-40)</PackageDescription>
    <NDC11Code>00363-0872-40</NDC11Code>
    <ProductNDC>0363-0872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cold And Flu Relief</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Walgreen Company</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
    <StrengthNumber>650; 30; 12.5</StrengthNumber>
    <StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0378-0872-99</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (0378-0872-99)  / 1 PATCH in 1 POUCH (0378-0872-16)  / 7 d in 1 PATCH</PackageDescription>
    <NDC11Code>00378-0872-99</NDC11Code>
    <ProductNDC>0378-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonidine</ProprietaryName>
    <NonProprietaryName>Clonidine</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20130304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076166</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CLONIDINE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/d</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
    <Description>Clonidine transdermal system, USP is a transdermal system providing continuous systemic delivery of clonidine for 7 days at an approximately constant rate. Clonidine is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2-[(2,6-Dichlorophenyl)imino]imidazolidine and has the following chemical structure. Meets USP Drug Release Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>0555-0872-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0555-0872-02) </PackageDescription>
    <NDC11Code>00555-0872-02</NDC11Code>
    <ProductNDC>0555-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
    <NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19961204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040159</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19961204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
    <Description>Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0555-0872-04</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (0555-0872-04) </PackageDescription>
    <NDC11Code>00555-0872-04</NDC11Code>
    <ProductNDC>0555-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
    <NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19961204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040159</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19961204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
    <Description>Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0573-0872-08</NDCCode>
    <PackageDescription>1 CYLINDER in 1 BLISTER PACK (0573-0872-08)  / 2.2 g in 1 CYLINDER</PackageDescription>
    <NDC11Code>00573-0872-08</NDC11Code>
    <ProductNDC>0573-0872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chapstick Total Hydration Moisture Tint Very Berry</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200225</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>101</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 helps prevent sunburn, 2 helps prevent and temporarily protects chafed, chapped or cracked lips.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0573-0872-11</NDCCode>
    <PackageDescription>1 CYLINDER in 1 CARTON (0573-0872-11)  / 2.2 g in 1 CYLINDER</PackageDescription>
    <NDC11Code>00573-0872-11</NDC11Code>
    <ProductNDC>0573-0872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chapstick Total Hydration Moisture Tint Very Berry</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200225</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Haleon US Holdings LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>101</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200311</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 helps prevent sunburn, 2 helps prevent and temporarily protects chafed, chapped or cracked lips.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0574-0872-05</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0574-0872-05)  &gt; 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00574-0872-05</NDC11Code>
    <ProductNDC>0574-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol Valerate</ProprietaryName>
    <NonProprietaryName>Estradiol Valerate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20100331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090920</ApplicationNumber>
    <LabelerName>Perrigo Company</LabelerName>
    <SubstanceName>ESTRADIOL VALERATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0713-0872-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0872-30) </PackageDescription>
    <NDC11Code>00713-0872-30</NDC11Code>
    <ProductNDC>0713-0872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azor</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022100</ApplicationNumber>
    <LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>5; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP &lt;140 mmHg or &lt;130 mmHg or a DBP &lt;90 mmHg or &lt;80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 51% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 60% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.</IndicationAndUsage>
    <Description>Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of Azor is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of Azor is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>10056-872-40</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (10056-872-40)</PackageDescription>
    <NDC11Code>10056-0872-40</NDC11Code>
    <ProductNDC>10056-872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fulton Street Market Night Time Cold And Flu</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120822</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Access Business Group LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
    <StrengthNumber>650; 30; 12.5</StrengthNumber>
    <StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10237-872-28</NDCCode>
    <PackageDescription>73 g in 1 CANISTER (10237-872-28) </PackageDescription>
    <NDC11Code>10237-0872-28</NDC11Code>
    <ProductNDC>10237-872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ultramax Invisible Solid - Cool Blast</ProprietaryName>
    <ProprietaryNameSuffix>Antiperspirant Deodorant Cool Blast</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M019</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>.19</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use reduces underarm perspiration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10812-872-01</NDCCode>
    <PackageDescription>141 g in 1 CAN (10812-872-01)</PackageDescription>
    <NDC11Code>10812-0872-01</NDC11Code>
    <ProductNDC>10812-872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Wet Skin Swim Humidity Sweat</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101001</StartMarketingDate>
    <EndMarketingDate>20181201</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>30; 80; 40; 80; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>13537-872-06</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-872-06)  &gt; 4 g in 1 TUBE (13537-872-05)</PackageDescription>
    <NDC11Code>13537-0872-06</NDC11Code>
    <ProductNDC>13537-872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Effet Parfait Rouge Amplifier</ProprietaryName>
    <ProprietaryNameSuffix>Amplifying Spf 15 (sobriete) - Brown</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140911</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE</SubstanceName>
    <StrengthNumber>.072</StrengthNumber>
    <StrengthUnit>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>14141-872-01</NDCCode>
    <PackageDescription>30 g in 1 TUBE (14141-872-01) </PackageDescription>
    <NDC11Code>14141-0872-01</NDC11Code>
    <ProductNDC>14141-872</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20 Dulce De Leche 260-n</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>BEL STAR S A</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>4; 2.4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>14593-872-01</NDCCode>
    <PackageDescription>15 kg in 1 DRUM (14593-872-01) </PackageDescription>
    <NDC11Code>14593-0872-01</NDC11Code>
    <ProductNDC>14593-872</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20210722</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>kg/15kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-03</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>22-JUL-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14593-872-02</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (14593-872-02) </PackageDescription>
    <NDC11Code>14593-0872-02</NDC11Code>
    <ProductNDC>14593-872</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20210722</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>kg/15kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-03</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>22-JUL-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14593-872-03</NDCCode>
    <PackageDescription>1 kg in 1 POUCH (14593-872-03) </PackageDescription>
    <NDC11Code>14593-0872-03</NDC11Code>
    <ProductNDC>14593-872</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20210722</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>kg/15kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-03</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>22-JUL-21</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0245-0872-42</NDCCode><ProprietaryName>Vogelxo</ProprietaryName><NonProprietaryName>Testosterone</NonProprietaryName></NDC><NDC><NDCCode>17224-872-42</NDCCode><ProprietaryName>Phentermine Hydrochloride</ProprietaryName><NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0245-0036-42</NDCCode><ProprietaryName>Prevalite</ProprietaryName><NonProprietaryName>Cholestyramine</NonProprietaryName></NDC><NDC><NDCCode>71335-0245-1</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>0245-0215-60</NDCCode><ProprietaryName>B-nexa</ProprietaryName><NonProprietaryName>Pyridoxine, Folic Acid, Calcium, And Ginger</NonProprietaryName></NDC><NDC><NDCCode>62217-245-49</NDCCode><ProprietaryName>Cabana Beach Club With Manuka Honey And Essential Oils Spf 50 Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>0002-0872-00</NDCCode><NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName></NDC><NDC><NDCCode>0002-0872-30</NDCCode><NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName></NDC><NDC><NDCCode>0046-0872-04</NDCCode><ProprietaryName>Premarin</ProprietaryName><NonProprietaryName>Conjugated Estrogens</NonProprietaryName></NDC><NDC><NDCCode>0046-0872-21</NDCCode><ProprietaryName>Premarin</ProprietaryName><NonProprietaryName>Conjugated Estrogens</NonProprietaryName></NDC><NDC><NDCCode>0113-0872-40</NDCCode><ProprietaryName>Good Sense Night Time Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName></NDC><NDC><NDCCode>0121-0872-20</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>0121-0872-40</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>0220-0872-41</NDCCode><ProprietaryName>Blatta Orientalis</ProprietaryName><NonProprietaryName>Blatta Orientalis</NonProprietaryName></NDC><NDC><NDCCode>0363-0872-40</NDCCode><ProprietaryName>Cold And Flu Relief</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName></NDC><NDC><NDCCode>0378-0872-99</NDCCode><ProprietaryName>Clonidine</ProprietaryName><NonProprietaryName>Clonidine</NonProprietaryName></NDC><NDC><NDCCode>0555-0872-02</NDCCode><ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName><NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName></NDC><NDC><NDCCode>0555-0872-04</NDCCode><ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName><NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName></NDC><NDC><NDCCode>0573-0872-08</NDCCode><ProprietaryName>Chapstick Total Hydration Moisture Tint Very Berry</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>0573-0872-11</NDCCode><ProprietaryName>Chapstick Total Hydration Moisture Tint Very Berry</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>0574-0872-05</NDCCode><ProprietaryName>Estradiol Valerate</ProprietaryName><NonProprietaryName>Estradiol Valerate</NonProprietaryName></NDC><NDC><NDCCode>0713-0872-30</NDCCode><ProprietaryName>Azor</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>10056-872-40</NDCCode><ProprietaryName>Fulton Street Market Night Time Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName></NDC><NDC><NDCCode>10237-872-28</NDCCode><ProprietaryName>Ultramax Invisible Solid - Cool Blast</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>10812-872-01</NDCCode><ProprietaryName>Neutrogena Wet Skin Swim Humidity Sweat</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>13537-872-06</NDCCode><ProprietaryName>Effet Parfait Rouge Amplifier</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>14141-872-01</NDCCode><ProprietaryName>Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20 Dulce De Leche 260-n</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>14593-872-01</NDCCode><NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName></NDC><NDC><NDCCode>14593-872-02</NDCCode><NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName></NDC><NDC><NDCCode>14593-872-03</NDCCode><NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
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      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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