RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (21 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "31722-035-23",
      "PackageDescription": "236.5 mL in 1 BOTTLE, PLASTIC (31722-035-23) ",
      "NDC11Code": "31722-0035-23",
      "ProductNDC": "31722-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aminocaproic Acid",
      "NonProprietaryName": "Aminocaproic Acid",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216464",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "AMINOCAPROIC ACID",
      "StrengthNumber": ".25",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
      "Status": "Active",
      "LastUpdate": "2022-11-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).",
      "Description": "Aminocaproic acid, USP is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is freely soluble in water, 0.1N hydrochloric acid, soluble in 0.1N sodium hydroxide. Slightly soluble in methanol, practically insoluble in chloroform and in diethyl ether. Aminocaproic acid oral solution, USP for oral administration, contains 0.25 g/mL of aminocaproic acid, USP with methylparaben 0.20%, propylparaben 0.05%, edetate disodium dihydrate 0.30% as preservatives and the following inactive ingredients: anhydrous citric acid, purified water, raspberry flavor, saccharin sodium and sorbitol solution."
    },
    {
      "NDCCode": "73069-035-23",
      "PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-035-23)  > 2 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "73069-0035-23",
      "ProductNDC": "73069-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Viatrexx-arthros",
      "NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
      "StartMarketingDate": "20190329",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "VIATREXX BIO INCORPORATED",
      "SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
      "StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31",
      "StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190506",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "31722-491-23",
      "PackageDescription": "1 BOTTLE in 1 CARTON (31722-491-23)  / 230 mL in 1 BOTTLE",
      "NDC11Code": "31722-0491-23",
      "ProductNDC": "31722-491",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin",
      "NonProprietaryName": "Nitrofurantoin",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219495",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "NITROFURANTOIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250702",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcusspecies, Staphylococcus aureus, Klebsiellaspecies and Enterobacterspecies . Limitations of Use  Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions ( 5.7)].   Usage  To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Nitrofurantoin oral suspension, USP contains nitrofurantoin monohydrate USP, a synthetic nitrofuran antibacterial agent specific for urinary tract infections. The chemical name is 2,4-Imidazolidinedione,1-[[(5-nitro-2-furanyl) methylene] amino]-;monohydrate. The molecular formula is C 8H 6N 4O 5ꞏH 2O and the molecular weight is 256.18. The structural formula is:.   Nitrofurantoin monohydrate USP is a lemon yellow crystalline powder. Nitrofurantoin oral suspension, USP is available as a opaque yellow color suspension for oral administration containing 25 mg/5 mL nitrofurantoin. Nitrofurantoin oral suspension, USP also contains the following inactive ingredients: banana flavor (contains flavouring ingredients and propylene glycol), carboxymethylcellulose sodium, citric acid monohydrate, glycerin, magnesium aluminum silicate, methylparaben, microcrystalline cellulose & carboxymethylcellulose sodium, natural peppermint flavour (contains flavouring ingredients, propylene glycol and benzyl alcohol), non-crystalline sorbitol solution, propylparaben, purified water, raspberry flavour (contains natural & artificial flavour and propylene glycol), trisodium citrate dihydrate powder."
    },
    {
      "NDCCode": "11084-035-18",
      "PackageDescription": "370 mL in 1 BOTTLE, PLASTIC (11084-035-18) ",
      "NDC11Code": "11084-0035-18",
      "ProductNDC": "11084-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcare Antiseptic Handrub",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210601",
      "EndMarketingDate": "20271231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "SC Johnson Professional USA, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210615",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "for hand sanitizing to reduce bacteria on the skin."
    },
    {
      "NDCCode": "11084-035-27",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (11084-035-27) ",
      "NDC11Code": "11084-0035-27",
      "ProductNDC": "11084-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcare Antiseptic Handrub",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210601",
      "EndMarketingDate": "20271231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "SC Johnson Professional USA, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210615",
      "EndMarketingDatePackage": "20271231",
      "SamplePackage": "N",
      "IndicationAndUsage": "for hand sanitizing to reduce bacteria on the skin."
    },
    {
      "NDCCode": "42851-035-81",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (42851-035-81)  > 81 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "42851-0035-81",
      "ProductNDC": "42851-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zo Skin Health Pigment Control Plus Brightening Creme Hydroquinone Plus Vitamin C",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180501",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "ZO Skin Health, Inc.",
      "SubstanceName": "HYDROQUINONE",
      "StrengthNumber": ".04",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51346-035-01",
      "PackageDescription": "12 g in 1 CARTON (51346-035-01)",
      "NDC11Code": "51346-0035-01",
      "ProductNDC": "51346-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Orchid Secret Pact",
      "ProprietaryNameSuffix": "Spf35 Pa Plus Plus Plus 23 Orchid Beige",
      "NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "NATURE REPUBLIC CO., LTD.",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "1.03; .72; .35",
      "StrengthUnit": "g/12g; g/12g; g/12g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "51621-035-01",
      "PackageDescription": "50 mL in 1 CARTON (51621-035-01)",
      "NDC11Code": "51621-0035-01",
      "ProductNDC": "51621-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Actifirm Recovery",
      "ProprietaryNameSuffix": "Gowoonsesang Expert",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20100601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "GOWOONSESANG COSMETICS CO., LTD.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mL/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-23",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "59285-035-01",
      "PackageDescription": "50 kg in 1 DRUM (59285-035-01) ",
      "NDC11Code": "59285-0035-01",
      "ProductNDC": "59285-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Zileuton",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20201229",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Optimus Drugs Private Limited",
      "SubstanceName": "ZILEUTON",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-11-23",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "29-DEC-20"
    },
    {
      "NDCCode": "61755-035-02",
      "PackageDescription": "1 KIT in 1 DOSE PACK (61755-035-02)  *  1 VIAL, GLASS in 1 CARTON (61755-024-01)  > 11.1 mL in 1 VIAL, GLASS (61755-024-00)  *  1 VIAL, GLASS in 1 CARTON (61755-025-01)  > 11.1 mL in 1 VIAL, GLASS (61755-025-00) ",
      "NDC11Code": "61755-0035-02",
      "ProductNDC": "61755-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Regen-cov",
      "NonProprietaryName": "Casirivimab And Imdevimab",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20210207",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Regeneron Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210207",
      "SamplePackage": "N",
      "IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
      "Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
    },
    {
      "NDCCode": "63187-458-28",
      "PackageDescription": "6 POUCH in 1 CARTON (63187-458-28)  > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63187-0458-28",
      "ProductNDC": "63187-458",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tri-sprintec",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20031229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075808",
      "LabelerName": "Proficient Rx LP",
      "Status": "Active",
      "LastUpdate": "2020-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception. In four clinical trials with Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP), a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 women-years. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. 221 patients received Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) and 234 patients received placebo. Mean age at enrollment for both groups was 28 years. At the end of 6 months, the mean total lesion count changes from 55 to 31 (42% reduction) in patients treated with Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) and from 54 to 38 (27% reduction) in patients similarly treated with placebo. Table 3 summarizes the changes in lesion count for each type of lesion in the ITT population. Based on the investigator’s global assessment conducted at the final visit, patients treated with Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) showed a statistically significant improvement in total lesions compared to those treated with placebo.",
      "Description": "Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate, USP (18,19-Dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol, USP (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized corn starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate, USP (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol, USP (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate, USP (18,19-Dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol, USP (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows. Norgestimate. C23H31NO3 M.W. 369.50. Ethinyl Estradiol. C20H24O2   M.W. 296.40."
    },
    {
      "NDCCode": "63629-2350-1",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (63629-2350-1)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "63629-2350-01",
      "ProductNDC": "63629-2350",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tri-estarylla",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20220901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090793",
      "LabelerName": "Bryant Ranch Prepack",
      "Status": "Active",
      "LastUpdate": "2024-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
      "Description": "Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white tablet contains 0.180 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, and pregelatinized starch., 2 Each active light blue tablet contains 0.215 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch, 3 Each active blue tablet contains 0.250 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch, 4 Each green tablet contains only inert ingredients, as follows: crospovidone, D &C Yellow No.10 Aluminum Lake, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch."
    },
    {
      "NDCCode": "63736-035-01",
      "PackageDescription": "1 KIT in 1 CARTON (63736-035-01)  *  1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE *  1 BOTTLE in 1 CARTON / 147.86 mL in 1 BOTTLE *  2 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE",
      "NDC11Code": "63736-0035-01",
      "ProductNDC": "63736-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nix Complete Lice Treatment",
      "NonProprietaryName": "Permethrin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20131115",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019918",
      "LabelerName": "Insight Pharmaceuticals LLC",
      "Status": "Active",
      "LastUpdate": "2025-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20131115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65923-035-40",
      "PackageDescription": "1 TUBE in 1 CARTON (65923-035-40)  / 40 g in 1 TUBE",
      "NDC11Code": "65923-0035-40",
      "ProductNDC": "65923-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gelmicin Hydrocortisone With Aloe",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210222",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "United Exchange Corp.",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210222",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: 1 before first use, remove or puncture seal under cap by using the tip of the cap, 2 for itching of skin irritation, inflammation, and rashes:, 3 adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily, 4 children under 2 years of age: ask a doctor, 5 for external anal and genital itching, adults:, 6 when practical, clean the affected area with mild soap and warm water and rinse thoroughly, 7 gently dry by patting or blotting with toilet tissue or a soft cloth before applying, 8 apply to affected area not more than 3 to 4 times daily, 9 children under 12 years of age: ask a doctor."
    },
    {
      "NDCCode": "66343-035-50",
      "PackageDescription": "50 mL in 1 BOTTLE, DROPPER (66343-035-50)",
      "NDC11Code": "66343-0035-50",
      "ProductNDC": "66343-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Emvita 23",
      "NonProprietaryName": "Copper, Toxicodendron Pubescens Leaf, Amanita Muscaria Fruiting Body, And Sus Scrofa Pituitary Gland",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150507",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "RUBIMED AG",
      "SubstanceName": "COPPER; TOXICODENDRON PUBESCENS LEAF; AMANITA MUSCARIA FRUITING BODY; SUS SCROFA PITUITARY GLAND",
      "StrengthNumber": "800; 18; 21; 21",
      "StrengthUnit": "[hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Homeopathic Combination Medicine Indications: Tenseness."
    },
    {
      "NDCCode": "71209-035-04",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (71209-035-04) ",
      "NDC11Code": "71209-0035-04",
      "ProductNDC": "71209-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230713",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206452",
      "LabelerName": "Cadila Pharmaceuticals Limited",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230713",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for: : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy , 2 Management of postherpetic neuralgia , 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia , 5 Management of neuropathic pain associated with spinal cord injury.",
      "Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white powder, with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in 3M hydrochloric acid, sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/water) at pH 7.4 is -1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard gelatin capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with mannitol (Pearlitol 160C) and talc as inactive ingredients. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg and 300 mg contains gelatin, red iron oxide and titanium dioxide. The capsule shell for 25 mg, 50 mg and 150 mg contains gelatin and titanium dioxide. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
    },
    {
      "NDCCode": "71610-035-45",
      "PackageDescription": "45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-45) ",
      "NDC11Code": "71610-0035-45",
      "ProductNDC": "71610-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Toprol",
      "ProprietaryNameSuffix": "Xl",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019962",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2018-02-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180126",
      "SamplePackage": "N",
      "IndicationAndUsage": "TOPROL-XL, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. TOPROL-XL is indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3).",
      "Description": "TOPROL-XL, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. TOPROL-XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin."
    },
    {
      "NDCCode": "71610-035-60",
      "PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-60) ",
      "NDC11Code": "71610-0035-60",
      "ProductNDC": "71610-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Toprol",
      "ProprietaryNameSuffix": "Xl",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019962",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2018-02-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180126",
      "SamplePackage": "N",
      "IndicationAndUsage": "TOPROL-XL, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. TOPROL-XL is indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3).",
      "Description": "TOPROL-XL, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. TOPROL-XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin."
    },
    {
      "NDCCode": "72189-035-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (72189-035-30) ",
      "NDC11Code": "72189-0035-30",
      "ProductNDC": "72189-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209743",
      "LabelerName": "Direct_Rx",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190905",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. [structure]. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac."
    },
    {
      "NDCCode": "72189-035-60",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (72189-035-60) ",
      "NDC11Code": "72189-0035-60",
      "ProductNDC": "72189-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209743",
      "LabelerName": "Direct_Rx",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190905",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. [structure]. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac."
    },
    {
      "NDCCode": "72189-035-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (72189-035-90) ",
      "NDC11Code": "72189-0035-90",
      "ProductNDC": "72189-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209743",
      "LabelerName": "Direct_Rx",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190905",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. [structure]. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac."
    },
    {
      "NDCCode": "72643-035-02",
      "PackageDescription": "5 kg in 1 DRUM (72643-035-02) ",
      "NDC11Code": "72643-0035-02",
      "ProductNDC": "72643-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Mebendazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230630",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SOLARA ACIVE PHARMA SCIENCES LIMITED",
      "SubstanceName": "MEBENDAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "30-JUN-23"
    },
    {
      "NDCCode": "72643-035-03",
      "PackageDescription": "10 kg in 1 DRUM (72643-035-03) ",
      "NDC11Code": "72643-0035-03",
      "ProductNDC": "72643-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Mebendazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230630",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SOLARA ACIVE PHARMA SCIENCES LIMITED",
      "SubstanceName": "MEBENDAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "30-JUN-23"
    },
    {
      "NDCCode": "72643-035-08",
      "PackageDescription": "20 kg in 1 DRUM (72643-035-08) ",
      "NDC11Code": "72643-0035-08",
      "ProductNDC": "72643-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Mebendazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230630",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SOLARA ACIVE PHARMA SCIENCES LIMITED",
      "SubstanceName": "MEBENDAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "30-JUN-23"
    },
    {
      "NDCCode": "72643-035-09",
      "PackageDescription": "15 kg in 1 DRUM (72643-035-09) ",
      "NDC11Code": "72643-0035-09",
      "ProductNDC": "72643-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Mebendazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230630",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SOLARA ACIVE PHARMA SCIENCES LIMITED",
      "SubstanceName": "MEBENDAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-12",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "30-JUN-23"
    },
    {
      "NDCCode": "73126-035-01",
      "PackageDescription": "59 mL in 1 BOTTLE, DISPENSING (73126-035-01) ",
      "NDC11Code": "73126-0035-01",
      "ProductNDC": "73126-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210611",
      "EndMarketingDate": "20240420",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "LAB-CLEAN, INC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210611",
      "EndMarketingDatePackage": "20240420",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73126-035-02",
      "PackageDescription": "88 mL in 1 BOTTLE, DISPENSING (73126-035-02) ",
      "NDC11Code": "73126-0035-02",
      "ProductNDC": "73126-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210611",
      "EndMarketingDate": "20240420",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
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      "SubstanceName": "BENZALKONIUM CHLORIDE",
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      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210611",
      "EndMarketingDatePackage": "20240420",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73126-035-03",
      "PackageDescription": "236 mL in 1 BOTTLE, DISPENSING (73126-035-03) ",
      "NDC11Code": "73126-0035-03",
      "ProductNDC": "73126-035",
      "ProductTypeName": "HUMAN OTC DRUG",
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      "SubstanceName": "BENZALKONIUM CHLORIDE",
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      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210611",
      "EndMarketingDatePackage": "20240420",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73126-035-04",
      "PackageDescription": "355 mL in 1 BOTTLE, DISPENSING (73126-035-04) ",
      "NDC11Code": "73126-0035-04",
      "ProductNDC": "73126-035",
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      "EndMarketingDate": "20240420",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "LAB-CLEAN, INC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
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      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210611",
      "EndMarketingDatePackage": "20240420",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "73126-035-05",
      "PackageDescription": "946 mL in 1 BOTTLE, DISPENSING (73126-035-05) ",
      "NDC11Code": "73126-0035-05",
      "ProductNDC": "73126-035",
      "ProductTypeName": "HUMAN OTC DRUG",
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      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210611",
      "EndMarketingDate": "20240420",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "LAB-CLEAN, INC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210611",
      "EndMarketingDatePackage": "20240420",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"31722-035-23","ProprietaryName":"Aminocaproic Acid","NonProprietaryName":"Aminocaproic Acid"},{"NDCCode":"73069-035-23","ProprietaryName":"Viatrexx-arthros","NonProprietaryName":"Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein"},{"NDCCode":"31722-491-23","ProprietaryName":"Nitrofurantoin","NonProprietaryName":"Nitrofurantoin"},{"NDCCode":"11084-035-18","ProprietaryName":"Alcare Antiseptic Handrub","NonProprietaryName":"Alcohol"},{"NDCCode":"11084-035-27","ProprietaryName":"Alcare Antiseptic Handrub","NonProprietaryName":"Alcohol"},{"NDCCode":"42851-035-81","ProprietaryName":"Zo Skin Health Pigment Control Plus Brightening Creme Hydroquinone Plus Vitamin C","NonProprietaryName":"Hydroquinone"},{"NDCCode":"51346-035-01","ProprietaryName":"Orchid Secret Pact","NonProprietaryName":"Titanium Dioxide, Octinoxate, Zinc Oxide"},{"NDCCode":"51621-035-01","ProprietaryName":"Actifirm Recovery","NonProprietaryName":"Dimethicone"},{"NDCCode":"59285-035-01","NonProprietaryName":"Zileuton"},{"NDCCode":"61755-035-02","ProprietaryName":"Regen-cov","NonProprietaryName":"Casirivimab And Imdevimab"},{"NDCCode":"63187-458-28","ProprietaryName":"Tri-sprintec","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"63629-2350-1","ProprietaryName":"Tri-estarylla","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"63736-035-01","ProprietaryName":"Nix Complete Lice Treatment","NonProprietaryName":"Permethrin"},{"NDCCode":"65923-035-40","ProprietaryName":"Gelmicin Hydrocortisone With Aloe","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"66343-035-50","ProprietaryName":"Emvita 23","NonProprietaryName":"Copper, Toxicodendron Pubescens Leaf, Amanita Muscaria Fruiting Body, And Sus Scrofa Pituitary Gland"},{"NDCCode":"71209-035-04","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"71610-035-45","ProprietaryName":"Toprol","NonProprietaryName":"Metoprolol Succinate"},{"NDCCode":"71610-035-60","ProprietaryName":"Toprol","NonProprietaryName":"Metoprolol Succinate"},{"NDCCode":"72189-035-30","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"72189-035-60","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"72189-035-90","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"72643-035-02","NonProprietaryName":"Mebendazole"},{"NDCCode":"72643-035-03","NonProprietaryName":"Mebendazole"},{"NDCCode":"72643-035-08","NonProprietaryName":"Mebendazole"},{"NDCCode":"72643-035-09","NonProprietaryName":"Mebendazole"},{"NDCCode":"73126-035-01","ProprietaryName":"Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"73126-035-02","ProprietaryName":"Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"73126-035-03","ProprietaryName":"Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"73126-035-04","ProprietaryName":"Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"73126-035-05","ProprietaryName":"Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free","NonProprietaryName":"Benzalkonium Chloride"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>31722-035-23</NDCCode>
    <PackageDescription>236.5 mL in 1 BOTTLE, PLASTIC (31722-035-23) </PackageDescription>
    <NDC11Code>31722-0035-23</NDC11Code>
    <ProductNDC>31722-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aminocaproic Acid</ProprietaryName>
    <NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216464</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMINOCAPROIC ACID</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).</IndicationAndUsage>
    <Description>Aminocaproic acid, USP is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is freely soluble in water, 0.1N hydrochloric acid, soluble in 0.1N sodium hydroxide. Slightly soluble in methanol, practically insoluble in chloroform and in diethyl ether. Aminocaproic acid oral solution, USP for oral administration, contains 0.25 g/mL of aminocaproic acid, USP with methylparaben 0.20%, propylparaben 0.05%, edetate disodium dihydrate 0.30% as preservatives and the following inactive ingredients: anhydrous citric acid, purified water, raspberry flavor, saccharin sodium and sorbitol solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>73069-035-23</NDCCode>
    <PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-035-23)  &gt; 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>73069-0035-23</NDC11Code>
    <ProductNDC>73069-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Viatrexx-arthros</ProprietaryName>
    <NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
    <SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
    <StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
    <StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>31722-491-23</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (31722-491-23)  / 230 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>31722-0491-23</NDC11Code>
    <ProductNDC>31722-491</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin</ProprietaryName>
    <NonProprietaryName>Nitrofurantoin</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250702</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219495</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NITROFURANTOIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcusspecies, Staphylococcus aureus, Klebsiellaspecies and Enterobacterspecies . Limitations of Use  Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions ( 5.7)].   Usage  To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Nitrofurantoin oral suspension, USP contains nitrofurantoin monohydrate USP, a synthetic nitrofuran antibacterial agent specific for urinary tract infections. The chemical name is 2,4-Imidazolidinedione,1-[[(5-nitro-2-furanyl) methylene] amino]-;monohydrate. The molecular formula is C 8H 6N 4O 5ꞏH 2O and the molecular weight is 256.18. The structural formula is:.   Nitrofurantoin monohydrate USP is a lemon yellow crystalline powder. Nitrofurantoin oral suspension, USP is available as a opaque yellow color suspension for oral administration containing 25 mg/5 mL nitrofurantoin. Nitrofurantoin oral suspension, USP also contains the following inactive ingredients: banana flavor (contains flavouring ingredients and propylene glycol), carboxymethylcellulose sodium, citric acid monohydrate, glycerin, magnesium aluminum silicate, methylparaben, microcrystalline cellulose &amp; carboxymethylcellulose sodium, natural peppermint flavour (contains flavouring ingredients, propylene glycol and benzyl alcohol), non-crystalline sorbitol solution, propylparaben, purified water, raspberry flavour (contains natural &amp; artificial flavour and propylene glycol), trisodium citrate dihydrate powder.</Description>
  </NDC>
  <NDC>
    <NDCCode>11084-035-18</NDCCode>
    <PackageDescription>370 mL in 1 BOTTLE, PLASTIC (11084-035-18) </PackageDescription>
    <NDC11Code>11084-0035-18</NDC11Code>
    <ProductNDC>11084-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcare Antiseptic Handrub</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210601</StartMarketingDate>
    <EndMarketingDate>20271231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210615</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for hand sanitizing to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11084-035-27</NDCCode>
    <PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (11084-035-27) </PackageDescription>
    <NDC11Code>11084-0035-27</NDC11Code>
    <ProductNDC>11084-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcare Antiseptic Handrub</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210601</StartMarketingDate>
    <EndMarketingDate>20271231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210615</StartMarketingDatePackage>
    <EndMarketingDatePackage>20271231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for hand sanitizing to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42851-035-81</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42851-035-81)  &gt; 81 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>42851-0035-81</NDC11Code>
    <ProductNDC>42851-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zo Skin Health Pigment Control Plus Brightening Creme Hydroquinone Plus Vitamin C</ProprietaryName>
    <NonProprietaryName>Hydroquinone</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180501</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>ZO Skin Health, Inc.</LabelerName>
    <SubstanceName>HYDROQUINONE</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51346-035-01</NDCCode>
    <PackageDescription>12 g in 1 CARTON (51346-035-01)</PackageDescription>
    <NDC11Code>51346-0035-01</NDC11Code>
    <ProductNDC>51346-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Orchid Secret Pact</ProprietaryName>
    <ProprietaryNameSuffix>Spf35 Pa Plus Plus Plus 23 Orchid Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>1.03; .72; .35</StrengthNumber>
    <StrengthUnit>g/12g; g/12g; g/12g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51621-035-01</NDCCode>
    <PackageDescription>50 mL in 1 CARTON (51621-035-01)</PackageDescription>
    <NDC11Code>51621-0035-01</NDC11Code>
    <ProductNDC>51621-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Actifirm Recovery</ProprietaryName>
    <ProprietaryNameSuffix>Gowoonsesang Expert</ProprietaryNameSuffix>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20100601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>GOWOONSESANG COSMETICS CO., LTD.</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mL/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-23</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>59285-035-01</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (59285-035-01) </PackageDescription>
    <NDC11Code>59285-0035-01</NDC11Code>
    <ProductNDC>59285-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Zileuton</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20201229</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Optimus Drugs Private Limited</LabelerName>
    <SubstanceName>ZILEUTON</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-11-23</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-DEC-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>61755-035-02</NDCCode>
    <PackageDescription>1 KIT in 1 DOSE PACK (61755-035-02)  *  1 VIAL, GLASS in 1 CARTON (61755-024-01)  &gt; 11.1 mL in 1 VIAL, GLASS (61755-024-00)  *  1 VIAL, GLASS in 1 CARTON (61755-025-01)  &gt; 11.1 mL in 1 VIAL, GLASS (61755-025-00) </PackageDescription>
    <NDC11Code>61755-0035-02</NDC11Code>
    <ProductNDC>61755-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Regen-cov</ProprietaryName>
    <NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210207</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
    <Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-458-28</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (63187-458-28)  &gt; 1 BLISTER PACK in 1 POUCH &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63187-0458-28</NDC11Code>
    <ProductNDC>63187-458</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tri-sprintec</ProprietaryName>
    <NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20031229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075808</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2020-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception. In four clinical trials with Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP), a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 women-years. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. 221 patients received Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) and 234 patients received placebo. Mean age at enrollment for both groups was 28 years. At the end of 6 months, the mean total lesion count changes from 55 to 31 (42% reduction) in patients treated with Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) and from 54 to 38 (27% reduction) in patients similarly treated with placebo. Table 3 summarizes the changes in lesion count for each type of lesion in the ITT population. Based on the investigator’s global assessment conducted at the final visit, patients treated with Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) showed a statistically significant improvement in total lesions compared to those treated with placebo.</IndicationAndUsage>
    <Description>Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate, USP (18,19-Dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol, USP (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&amp;C blue no. 2, FD&amp;C red no. 40, FD&amp;C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized corn starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate, USP (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol, USP (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&amp;C blue no. 2 aluminum lake (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&amp;C blue no. 2, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate, USP (18,19-Dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol, USP (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&amp;C blue no. 2 aluminum lake (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&amp;C blue no. 2, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows. Norgestimate. C23H31NO3 M.W. 369.50. Ethinyl Estradiol. C20H24O2   M.W. 296.40.</Description>
  </NDC>
  <NDC>
    <NDCCode>63629-2350-1</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (63629-2350-1)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63629-2350-01</NDC11Code>
    <ProductNDC>63629-2350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tri-estarylla</ProprietaryName>
    <NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20220901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090793</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-05-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
    <Description>Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white tablet contains 0.180 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, and pregelatinized starch., 2 Each active light blue tablet contains 0.215 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD &amp; C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch, 3 Each active blue tablet contains 0.250 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD &amp; C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch, 4 Each green tablet contains only inert ingredients, as follows: crospovidone, D &amp;C Yellow No.10 Aluminum Lake, FD &amp; C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>63736-035-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (63736-035-01)  *  1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE *  1 BOTTLE in 1 CARTON / 147.86 mL in 1 BOTTLE *  2 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>63736-0035-01</NDC11Code>
    <ProductNDC>63736-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nix Complete Lice Treatment</ProprietaryName>
    <NonProprietaryName>Permethrin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20131115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019918</ApplicationNumber>
    <LabelerName>Insight Pharmaceuticals LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65923-035-40</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (65923-035-40)  / 40 g in 1 TUBE</PackageDescription>
    <NDC11Code>65923-0035-40</NDC11Code>
    <ProductNDC>65923-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gelmicin Hydrocortisone With Aloe</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>United Exchange Corp.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions: 1 before first use, remove or puncture seal under cap by using the tip of the cap, 2 for itching of skin irritation, inflammation, and rashes:, 3 adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily, 4 children under 2 years of age: ask a doctor, 5 for external anal and genital itching, adults:, 6 when practical, clean the affected area with mild soap and warm water and rinse thoroughly, 7 gently dry by patting or blotting with toilet tissue or a soft cloth before applying, 8 apply to affected area not more than 3 to 4 times daily, 9 children under 12 years of age: ask a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66343-035-50</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE, DROPPER (66343-035-50)</PackageDescription>
    <NDC11Code>66343-0035-50</NDC11Code>
    <ProductNDC>66343-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Emvita 23</ProprietaryName>
    <NonProprietaryName>Copper, Toxicodendron Pubescens Leaf, Amanita Muscaria Fruiting Body, And Sus Scrofa Pituitary Gland</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150507</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>RUBIMED AG</LabelerName>
    <SubstanceName>COPPER; TOXICODENDRON PUBESCENS LEAF; AMANITA MUSCARIA FRUITING BODY; SUS SCROFA PITUITARY GLAND</SubstanceName>
    <StrengthNumber>800; 18; 21; 21</StrengthNumber>
    <StrengthUnit>[hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Homeopathic Combination Medicine Indications: Tenseness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71209-035-04</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (71209-035-04) </PackageDescription>
    <NDC11Code>71209-0035-04</NDC11Code>
    <ProductNDC>71209-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230713</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206452</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy , 2 Management of postherpetic neuralgia , 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia , 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white powder, with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in 3M hydrochloric acid, sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/water) at pH 7.4 is -1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard gelatin capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with mannitol (Pearlitol 160C) and talc as inactive ingredients. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg and 300 mg contains gelatin, red iron oxide and titanium dioxide. The capsule shell for 25 mg, 50 mg and 150 mg contains gelatin and titanium dioxide. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-035-45</NDCCode>
    <PackageDescription>45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-45) </PackageDescription>
    <NDC11Code>71610-0035-45</NDC11Code>
    <ProductNDC>71610-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Toprol</ProprietaryName>
    <ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019962</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-02-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TOPROL-XL, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. TOPROL-XL is indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3).</IndicationAndUsage>
    <Description>TOPROL-XL, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. TOPROL-XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-035-60</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-60) </PackageDescription>
    <NDC11Code>71610-0035-60</NDC11Code>
    <ProductNDC>71610-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Toprol</ProprietaryName>
    <ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019962</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-02-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TOPROL-XL, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. TOPROL-XL is indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3).</IndicationAndUsage>
    <Description>TOPROL-XL, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. TOPROL-XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-035-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (72189-035-30) </PackageDescription>
    <NDC11Code>72189-0035-30</NDC11Code>
    <ProductNDC>72189-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. [structure]. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-035-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (72189-035-60) </PackageDescription>
    <NDC11Code>72189-0035-60</NDC11Code>
    <ProductNDC>72189-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. [structure]. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-035-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (72189-035-90) </PackageDescription>
    <NDC11Code>72189-0035-90</NDC11Code>
    <ProductNDC>72189-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. [structure]. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>72643-035-02</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (72643-035-02) </PackageDescription>
    <NDC11Code>72643-0035-02</NDC11Code>
    <ProductNDC>72643-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Mebendazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SOLARA ACIVE PHARMA SCIENCES LIMITED</LabelerName>
    <SubstanceName>MEBENDAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JUN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>72643-035-03</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (72643-035-03) </PackageDescription>
    <NDC11Code>72643-0035-03</NDC11Code>
    <ProductNDC>72643-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Mebendazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SOLARA ACIVE PHARMA SCIENCES LIMITED</LabelerName>
    <SubstanceName>MEBENDAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JUN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>72643-035-08</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (72643-035-08) </PackageDescription>
    <NDC11Code>72643-0035-08</NDC11Code>
    <ProductNDC>72643-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Mebendazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SOLARA ACIVE PHARMA SCIENCES LIMITED</LabelerName>
    <SubstanceName>MEBENDAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JUN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>72643-035-09</NDCCode>
    <PackageDescription>15 kg in 1 DRUM (72643-035-09) </PackageDescription>
    <NDC11Code>72643-0035-09</NDC11Code>
    <ProductNDC>72643-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Mebendazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SOLARA ACIVE PHARMA SCIENCES LIMITED</LabelerName>
    <SubstanceName>MEBENDAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-JUN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>73126-035-01</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DISPENSING (73126-035-01) </PackageDescription>
    <NDC11Code>73126-0035-01</NDC11Code>
    <ProductNDC>73126-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210611</StartMarketingDate>
    <EndMarketingDate>20240420</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>LAB-CLEAN, INC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210611</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240420</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73126-035-02</NDCCode>
    <PackageDescription>88 mL in 1 BOTTLE, DISPENSING (73126-035-02) </PackageDescription>
    <NDC11Code>73126-0035-02</NDC11Code>
    <ProductNDC>73126-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210611</StartMarketingDate>
    <EndMarketingDate>20240420</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>LAB-CLEAN, INC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210611</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240420</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73126-035-03</NDCCode>
    <PackageDescription>236 mL in 1 BOTTLE, DISPENSING (73126-035-03) </PackageDescription>
    <NDC11Code>73126-0035-03</NDC11Code>
    <ProductNDC>73126-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210611</StartMarketingDate>
    <EndMarketingDate>20240420</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>LAB-CLEAN, INC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210611</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240420</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73126-035-04</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE, DISPENSING (73126-035-04) </PackageDescription>
    <NDC11Code>73126-0035-04</NDC11Code>
    <ProductNDC>73126-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210611</StartMarketingDate>
    <EndMarketingDate>20240420</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>LAB-CLEAN, INC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210611</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240420</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>73126-035-05</NDCCode>
    <PackageDescription>946 mL in 1 BOTTLE, DISPENSING (73126-035-05) </PackageDescription>
    <NDC11Code>73126-0035-05</NDC11Code>
    <ProductNDC>73126-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210611</StartMarketingDate>
    <EndMarketingDate>20240420</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>LAB-CLEAN, INC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210611</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240420</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>31722-035-23</NDCCode><ProprietaryName>Aminocaproic Acid</ProprietaryName><NonProprietaryName>Aminocaproic Acid</NonProprietaryName></NDC><NDC><NDCCode>73069-035-23</NDCCode><ProprietaryName>Viatrexx-arthros</ProprietaryName><NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName></NDC><NDC><NDCCode>31722-491-23</NDCCode><ProprietaryName>Nitrofurantoin</ProprietaryName><NonProprietaryName>Nitrofurantoin</NonProprietaryName></NDC><NDC><NDCCode>11084-035-18</NDCCode><ProprietaryName>Alcare Antiseptic Handrub</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>11084-035-27</NDCCode><ProprietaryName>Alcare Antiseptic Handrub</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>42851-035-81</NDCCode><ProprietaryName>Zo Skin Health Pigment Control Plus Brightening Creme Hydroquinone Plus Vitamin C</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>51346-035-01</NDCCode><ProprietaryName>Orchid Secret Pact</ProprietaryName><NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>51621-035-01</NDCCode><ProprietaryName>Actifirm Recovery</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>59285-035-01</NDCCode><NonProprietaryName>Zileuton</NonProprietaryName></NDC><NDC><NDCCode>61755-035-02</NDCCode><ProprietaryName>Regen-cov</ProprietaryName><NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName></NDC><NDC><NDCCode>63187-458-28</NDCCode><ProprietaryName>Tri-sprintec</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63629-2350-1</NDCCode><ProprietaryName>Tri-estarylla</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>63736-035-01</NDCCode><ProprietaryName>Nix Complete Lice Treatment</ProprietaryName><NonProprietaryName>Permethrin</NonProprietaryName></NDC><NDC><NDCCode>65923-035-40</NDCCode><ProprietaryName>Gelmicin Hydrocortisone With Aloe</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>66343-035-50</NDCCode><ProprietaryName>Emvita 23</ProprietaryName><NonProprietaryName>Copper, Toxicodendron Pubescens Leaf, Amanita Muscaria Fruiting Body, And Sus Scrofa Pituitary Gland</NonProprietaryName></NDC><NDC><NDCCode>71209-035-04</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>71610-035-45</NDCCode><ProprietaryName>Toprol</ProprietaryName><NonProprietaryName>Metoprolol Succinate</NonProprietaryName></NDC><NDC><NDCCode>71610-035-60</NDCCode><ProprietaryName>Toprol</ProprietaryName><NonProprietaryName>Metoprolol Succinate</NonProprietaryName></NDC><NDC><NDCCode>72189-035-30</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>72189-035-60</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>72189-035-90</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>72643-035-02</NDCCode><NonProprietaryName>Mebendazole</NonProprietaryName></NDC><NDC><NDCCode>72643-035-03</NDCCode><NonProprietaryName>Mebendazole</NonProprietaryName></NDC><NDC><NDCCode>72643-035-08</NDCCode><NonProprietaryName>Mebendazole</NonProprietaryName></NDC><NDC><NDCCode>72643-035-09</NDCCode><NonProprietaryName>Mebendazole</NonProprietaryName></NDC><NDC><NDCCode>73126-035-01</NDCCode><ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73126-035-02</NDCCode><ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73126-035-03</NDCCode><ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73126-035-04</NDCCode><ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73126-035-05</NDCCode><ProprietaryName>Bayes Alcohol Free Foaming Hand Sanitizer Fragrance Free</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
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}
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