RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "0904-5694-01",
      "PackageDescription": "1 POUCH in 1 PACKAGE (0904-5694-01)  > 5 PATCH in 1 POUCH",
      "NDC11Code": "00904-5694-01",
      "ProductNDC": "0904-5694",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Major Extra Strength Cold And Hot Pain Relief Therapy",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130630",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Directions: 1 adults and children 12 years:, 2 remove backing from patch by grasping both ends firmly and gently pulling until backing seperates in middle, 3 carefully remove backing from patch, 4 apply one patch to affected area, 5 wear one patch up to 8 hours, 6 repeat as necessary, but no more than 4 times daily ."
    },
    {
      "NDCCode": "0591-5694-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-01) ",
      "NDC11Code": "00591-5694-01",
      "ProductNDC": "0591-5694",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19920201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA063181",
      "LabelerName": "Actavis Pharma, Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19920201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules 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": "Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl                      M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, propylene glycol, and shellac glaze."
    },
    {
      "NDCCode": "50090-5694-1",
      "PackageDescription": "90 TABLET in 1 BOTTLE (50090-5694-1) ",
      "NDC11Code": "50090-5694-01",
      "ProductNDC": "50090-5694",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide 20/12.5",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170424",
      "EndMarketingDate": "20240531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206515",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "12.5; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210922",
      "EndMarketingDatePackage": "20240531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of olmesartan, an angiotensin II receptor blocker and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1).",
      "Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, USP is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Additionally, the 40 mg/25 mg tablets contain ferric oxide red. The 20 mg/12.5 mg and 40 mg/12.5 mg tablets contain ferric oxide red and ferric oxide yellow."
    },
    {
      "NDCCode": "50090-5694-0",
      "PackageDescription": "30 TABLET in 1 BOTTLE (50090-5694-0) ",
      "NDC11Code": "50090-5694-00",
      "ProductNDC": "50090-5694",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide 20/12.5",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170424",
      "EndMarketingDate": "20240531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206515",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "12.5; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210922",
      "EndMarketingDatePackage": "20240531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of olmesartan, an angiotensin II receptor blocker and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1).",
      "Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, USP is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Additionally, the 40 mg/25 mg tablets contain ferric oxide red. The 20 mg/12.5 mg and 40 mg/12.5 mg tablets contain ferric oxide red and ferric oxide yellow."
    },
    {
      "NDCCode": "0441-0904-01",
      "PackageDescription": "100 g in 1 BOTTLE, PLASTIC (0441-0904-01) ",
      "NDC11Code": "00441-0904-01",
      "ProductNDC": "0441-0904",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tripalmitin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19851223",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Sigma-Aldrich Corporation",
      "SubstanceName": "TRIPALMITIN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-04-07",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "23-DEC-85"
    },
    {
      "NDCCode": "0904-5415-01",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (0904-5415-01)  *  3 SUPPOSITORY in 1 BLISTER PACK *  9 g in 1 TUBE",
      "NDC11Code": "00904-5415-01",
      "ProductNDC": "0904-5415",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Miconazole 3 Combination Pack",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "KIT",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20021202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074926",
      "LabelerName": "Major Pharmaceuticals",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20021202",
      "SamplePackage": "N",
      "IndicationAndUsage": "treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection."
    },
    {
      "NDCCode": "0904-5758-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0904-5758-01)  > 30 TABLET in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00904-5758-01",
      "ProductNDC": "0904-5758",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucus Relief",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051222",
      "EndMarketingDate": "20181104",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-06",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "0904-5792-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0904-5792-01)  > 30 TABLET in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00904-5792-01",
      "ProductNDC": "0904-5792",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sinus Congestion Pe",
      "NonProprietaryName": "Guaifenesin And Phenylephrine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060415",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "400; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2015-08-21"
    },
    {
      "NDCCode": "0904-6013-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0904-6013-01)  > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00904-6013-01",
      "ProductNDC": "0904-6013",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucus Relief Dm",
      "NonProprietaryName": "Dextromethorphan Hbr And Guiafenesin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
      "StrengthNumber": "20; 400",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "0904-6443-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0904-6443-01) ",
      "NDC11Code": "00904-6443-01",
      "ProductNDC": "0904-6443",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150514",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA086242",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20150514",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-6449-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6449-01)",
      "NDC11Code": "00904-6449-01",
      "ProductNDC": "0904-6449",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isosorbide Mononitrate",
      "NonProprietaryName": "Isosorbide Mononitrate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200270",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "ISOSORBIDE MONONITRATE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-30"
    },
    {
      "NDCCode": "0904-6450-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6450-01)",
      "NDC11Code": "00904-6450-01",
      "ProductNDC": "0904-6450",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isosorbide Mononitrate",
      "NonProprietaryName": "Isosorbide Mononitrate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200495",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "ISOSORBIDE MONONITRATE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-30"
    },
    {
      "NDCCode": "0904-6451-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6451-01)",
      "NDC11Code": "00904-6451-01",
      "ProductNDC": "0904-6451",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isosorbide Mononitrate",
      "NonProprietaryName": "Isosorbide Mononitrate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200495",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "ISOSORBIDE MONONITRATE",
      "StrengthNumber": "120",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-30"
    },
    {
      "NDCCode": "0904-7116-01",
      "PackageDescription": "30 CUP in 1 CASE (0904-7116-01)  / 10 mL in 1 CUP (0904-7116-66) ",
      "NDC11Code": "00904-7116-01",
      "ProductNDC": "0904-7116",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbamazepine",
      "NonProprietaryName": "Carbamazepine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076729",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "CARBAMAZEPINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20040920",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 2.Generalized tonic-clonic seizures (grand mal)., 3 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .",
      "Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 and 200 mg, tablets of 200 mg, extended-release tablets of 100 mg, 200 mg, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients:Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg –ammonio methacrylate copolymer, croscarmellose sodium, diethyl phthalate, FD&C red no. 40 lake, magnesium stearate, microcrystalline cellulose, natural cherry flavor, pregelatinized maize starch and sorbitol. Carbamazepine Tablets USP, 200 mg– ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose. Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg– ammonio methacrylate copolymer, corn starch, diethyl phthalate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Carbamazepine Oral Suspension USP, 100 mg/5 mL– citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum."
    },
    {
      "NDCCode": "0904-7332-17",
      "PackageDescription": "25 POUCH in 1 CARTON (0904-7332-17)  / 1 SUPPOSITORY in 1 POUCH (0904-7332-01) ",
      "NDC11Code": "00904-7332-17",
      "ProductNDC": "0904-7332",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Glycerin",
      "NonProprietaryName": "Glycerin Suppository",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20240713",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "MAJOR� PHARMACEUTICALS",
      "SubstanceName": "GLYCERIN",
      "StrengthNumber": "1.2",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240713",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of occasional constipation. This product usually produces a bowel movement in 1/4 to 1 hour."
    },
    {
      "NDCCode": "0904-7333-17",
      "PackageDescription": "25 POUCH in 1 CARTON (0904-7333-17)  / 1 SUPPOSITORY in 1 POUCH (0904-7333-01) ",
      "NDC11Code": "00904-7333-17",
      "ProductNDC": "0904-7333",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Glycerin",
      "NonProprietaryName": "Glycerin Suppository",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20240703",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "MAJOR� PHARMACEUTICALS",
      "SubstanceName": "GLYCERIN",
      "StrengthNumber": "2",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240703",
      "SamplePackage": "N",
      "IndicationAndUsage": "For relief of occasional constipation. This product usually produces a bowel movement in ¼ to 1 hour."
    },
    {
      "NDCCode": "0904-7342-01",
      "PackageDescription": "1 PATCH in 1 POUCH (0904-7342-01)  / 9 g in 1 PATCH",
      "NDC11Code": "00904-7342-01",
      "ProductNDC": "0904-7342",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Major Arthritis Pain Relief Patch",
      "NonProprietaryName": "Menthol, Methyl Salicylate",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230401",
      "EndMarketingDate": "20260425",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "MENTHOL; METHYL SALICYLATE",
      "StrengthNumber": "3; 10",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230501",
      "EndMarketingDatePackage": "20260425",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: ■ strains ■ sprains ■ simple backache ■ arthritis ■ bruises."
    },
    {
      "NDCCode": "0904-7470-01",
      "PackageDescription": "30 CUP, UNIT-DOSE in 1 CASE (0904-7470-01)  / 10 mL in 1 CUP, UNIT-DOSE (0904-7470-66) ",
      "NDC11Code": "00904-7470-01",
      "ProductNDC": "0904-7470",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sucralfate",
      "NonProprietaryName": "Sucralfate Oral Suspension",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240626",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211884",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "SUCRALFATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/10mL",
      "Pharm_Classes": "Aluminum Complex [EPC], Organometallic Compounds [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240626",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sucralfate Oral Suspension is indicated in the short-term (up to 8weeks) treatment of active duodenal ulcer.",
      "Description": "Sucralfate Oral Suspension contains sucralfate and sucralfate is an β-D-glucopyranoside, α-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate Oral Suspension also contains: colloidal silicon dioxide, FD&C Red No. 40, wild cherry flavor (contains propylene glycol, artificial flavors, natural flavors, ethyl alcohol), glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion, sorbitol solution. Therapeutic category: antiulcer."
    },
    {
      "NDCCode": "11071-904-01",
      "PackageDescription": "40000 TABLET in 1 DRUM (11071-904-01)",
      "NDC11Code": "11071-0904-01",
      "ProductNDC": "11071-904",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Perampanel",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20121022",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Eisai Co., Ltd.",
      "SubstanceName": "PERAMPANEL",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CIII",
      "Status": "Unfinished",
      "LastUpdate": "2019-05-10",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "11822-0904-1",
      "PackageDescription": "20 BLISTER PACK in 1 CARTON (11822-0904-1)  / 1 GUM, CHEWING in 1 BLISTER PACK",
      "NDC11Code": "11822-0904-01",
      "ProductNDC": "11822-0904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nictoine Gum",
      "NonProprietaryName": "Nicotine Polacrilex",
      "DosageFormName": "GUM, CHEWING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170117",
      "EndMarketingDate": "20260930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206394",
      "LabelerName": "Rite Aid Corporation",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170117",
      "EndMarketingDatePackage": "20260930",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
    },
    {
      "NDCCode": "16714-904-01",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-904-01) ",
      "NDC11Code": "16714-0904-01",
      "ProductNDC": "16714-904",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190410",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091272",
      "LabelerName": "NorthStar RxLLC",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190410",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Venlafaxine hydrochloride extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for.",
      "Description": "Venlafaxine hydrochloride extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine hydrochloride extended-release tablets are formulated as an extended-release tablet for once-a-day oral administration. Venlafaxine hydrochloride extended-release tablets use a hydrogel-based technology to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system comprises of a bilayer tablet surrounded by a partially permeable coat. The bilayer tablet core consists of one colored swellable layer and a second drug containing layer. On contact of tablet with aqueous medium, the soluble components of the partially permeable membrane dissolve. Imbibition of the aqueous medium by the swellable layer causes it to swell rapidly. This exerts mechanical pressure on the coating causing it to rupture. The coating is removed from the swellable layer side only to expose a pre-defined surface area from which release of the drug occurs. The controlled rate of drug delivery is a function of controlled surface area and the excipients of the drug layer.The biologically inert fragments of the coating may remain intact and may be eliminated in the feces.Each extended-release coated bilayer tablet contains venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of hypromellose, povidone, lactose monohydrate, methacrylic acid copolymer, talc, magnesium stearate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, sodium lauryl sulfate, FD & C Red No. 40 Aluminum Lake, ethyl cellulose aqueous dispersion, mannitol, dibutyl sebacate, triethyl citrate, polysorbate 20, polyethylene glycol, polysorbate 80, and polyvinyl alcohol.  Imprinting ink contains shellac glaze, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol and ammonium hydroxide."
    },
    {
      "NDCCode": "31722-904-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (31722-904-01)",
      "NDC11Code": "31722-0904-01",
      "ProductNDC": "31722-904",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine",
      "NonProprietaryName": "Fluoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204597",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine  and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax® .",
      "Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3- [(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
    },
    {
      "NDCCode": "37000-904-01",
      "PackageDescription": "1.5 mL in 1 POUCH (37000-904-01)",
      "NDC11Code": "37000-0904-01",
      "ProductNDC": "37000-904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dolce And Gabbana The Lift Foundation Bronze 144",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140405",
      "EndMarketingDate": "20170401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "29.9; 25.2",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-04-04"
    },
    {
      "NDCCode": "37662-0904-1",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-0904-1) ",
      "NDC11Code": "37662-0904-01",
      "ProductNDC": "37662-0904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kalmia Latifolia",
      "NonProprietaryName": "Kalmia Latifolia",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220714",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "KALMIA LATIFOLIA LEAF",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2022-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220714",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37835-904-01",
      "PackageDescription": "1 TUBE in 1 CARTON (37835-904-01)  / 28.4 g in 1 TUBE",
      "NDC11Code": "37835-0904-01",
      "ProductNDC": "37835-904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triple Antibiotic Plus Pain Relief",
      "NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "Bi-Mart",
      "SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
      "StrengthNumber": "400; 5; 10000; 10",
      "StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g; mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240701",
      "SamplePackage": "N",
      "IndicationAndUsage": "first aid to help prevent infection and for the temporary relief of pain in minor: 1 cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "42385-904-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42385-904-01) ",
      "NDC11Code": "42385-0904-01",
      "ProductNDC": "42385-904",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209882",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43742-0904-1",
      "PackageDescription": "1 DOSE PACK in 1 CARTON (43742-0904-1)  > 1 KIT in 1 DOSE PACK *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0905-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0909-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0908-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0907-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0906-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0914-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0913-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0912-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0911-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0910-1) ",
      "NDC11Code": "43742-0904-01",
      "ProductNDC": "43742-0904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bartonella Kit",
      "NonProprietaryName": "Bartonella Bacilliformis, Bartonella Clarridgeiae, Bartonella Elizabethae, Bartonella Henselae, Bartonella Quintana, Bartonella Vinsonii, Bartonella Washoensis",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20161128",
      "EndMarketingDate": "20221023",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Deseret Biologicals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161128",
      "EndMarketingDatePackage": "20221023",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "44911-0904-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (44911-0904-1) ",
      "NDC11Code": "44911-0904-01",
      "ProductNDC": "44911-0904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Renatone",
      "NonProprietaryName": "Berberis Vulgaris, Solidago Virgaurea, Cantharis, Arsenicum Album, Coccus Cacti, Lycopodium Clavatum, Phosphorus, Senecio Aureus, Staphysagria",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260227",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Energique, Inc.",
      "SubstanceName": "BERBERIS VULGARIS ROOT BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; LYTTA VESICATORIA; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PACKERA AUREA WHOLE; STAPHISAGRIA MACROSPERMA SEED",
      "StrengthNumber": "3; 3; 12; 12; 12; 12; 12; 12; 12",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Active",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260227",
      "SamplePackage": "N",
      "IndicationAndUsage": "May temporarily relieve urine that is scanty, dark, and offensive, pain in the back, and sensation as if some urine remained after urinating.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
    },
    {
      "NDCCode": "48292-0904-1",
      "PackageDescription": "1 kg in 1 CARTON (48292-0904-1) ",
      "NDC11Code": "48292-0904-01",
      "ProductNDC": "48292-0904",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Albuterol Salbutamol Base",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150213",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SICOR Societa' Italiana Corticosteroidi s.r.l.",
      "SubstanceName": "ALBUTEROL",
      "StrengthNumber": "100",
      "StrengthUnit": "kg/100kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-02-01",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "13-FEB-15"
    },
    {
      "NDCCode": "49967-904-01",
      "PackageDescription": "1 TUBE in 1 CARTON (49967-904-01)  / 32 mL in 1 TUBE",
      "NDC11Code": "49967-0904-01",
      "ProductNDC": "49967-904",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "It Cosmetics Your Skin But Better Cc Plus Color Correcting Broad Spectrum Spf 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral Rich",
      "NonProprietaryName": "Homosalate, Octisalate And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M",
      "LabelerName": "L�Oreal USA Products Inc",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE",
      "StrengthNumber": "100; 40; 50",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250801",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ helps prevent sunburn. ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>0904-5694-01</NDCCode>
    <PackageDescription>1 POUCH in 1 PACKAGE (0904-5694-01)  &gt; 5 PATCH in 1 POUCH</PackageDescription>
    <NDC11Code>00904-5694-01</NDC11Code>
    <ProductNDC>0904-5694</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Major Extra Strength Cold And Hot Pain Relief Therapy</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions: 1 adults and children 12 years:, 2 remove backing from patch by grasping both ends firmly and gently pulling until backing seperates in middle, 3 carefully remove backing from patch, 4 apply one patch to affected area, 5 wear one patch up to 8 hours, 6 repeat as necessary, but no more than 4 times daily .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0591-5694-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-01) </PackageDescription>
    <NDC11Code>00591-5694-01</NDC11Code>
    <ProductNDC>0591-5694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19920201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA063181</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19920201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules 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>Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl                      M.W. 493.94. Each minocycline hydrochloride capsule, USP, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition, each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg, and 100 mg capsule shells contain: D&amp;C Red No. 28, D&amp;C Yellow No. 10, gelatin, and titanium dioxide. The 75 mg capsule shell also contains FD&amp;C Yellow No. 6. The 100 mg capsule shell also contains black iron oxide. The black imprinting ink contains the following ingredients that are common to all strengths: black iron oxide, butyl alcohol, D&amp;C Yellow #10 aluminum lake, FD&amp;C Blue #1 aluminum lake, FD&amp;C Blue #2 aluminum lake, FD&amp;C Red #40 aluminum lake, propylene glycol, and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5694-1</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-5694-1) </PackageDescription>
    <NDC11Code>50090-5694-01</NDC11Code>
    <ProductNDC>50090-5694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide 20/12.5</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170424</StartMarketingDate>
    <EndMarketingDate>20240531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206515</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>12.5; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210922</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of olmesartan, an angiotensin II receptor blocker and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1).</IndicationAndUsage>
    <Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, USP is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Additionally, the 40 mg/25 mg tablets contain ferric oxide red. The 20 mg/12.5 mg and 40 mg/12.5 mg tablets contain ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5694-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (50090-5694-0) </PackageDescription>
    <NDC11Code>50090-5694-00</NDC11Code>
    <ProductNDC>50090-5694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide 20/12.5</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170424</StartMarketingDate>
    <EndMarketingDate>20240531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206515</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>12.5; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210922</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of olmesartan, an angiotensin II receptor blocker and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1).</IndicationAndUsage>
    <Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, USP is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Additionally, the 40 mg/25 mg tablets contain ferric oxide red. The 20 mg/12.5 mg and 40 mg/12.5 mg tablets contain ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>0441-0904-01</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE, PLASTIC (0441-0904-01) </PackageDescription>
    <NDC11Code>00441-0904-01</NDC11Code>
    <ProductNDC>0441-0904</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tripalmitin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19851223</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Sigma-Aldrich Corporation</LabelerName>
    <SubstanceName>TRIPALMITIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-04-07</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-DEC-85</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-5415-01</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (0904-5415-01)  *  3 SUPPOSITORY in 1 BLISTER PACK *  9 g in 1 TUBE</PackageDescription>
    <NDC11Code>00904-5415-01</NDC11Code>
    <ProductNDC>0904-5415</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Miconazole 3 Combination Pack</ProprietaryName>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20021202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074926</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20021202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-5758-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0904-5758-01)  &gt; 30 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00904-5758-01</NDC11Code>
    <ProductNDC>0904-5758</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051222</StartMarketingDate>
    <EndMarketingDate>20181104</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-06</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>0904-5792-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0904-5792-01)  &gt; 30 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00904-5792-01</NDC11Code>
    <ProductNDC>0904-5792</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sinus Congestion Pe</ProprietaryName>
    <NonProprietaryName>Guaifenesin And Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060415</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>400; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-08-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0904-6013-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0904-6013-01)  &gt; 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00904-6013-01</NDC11Code>
    <ProductNDC>0904-6013</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief Dm</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr And Guiafenesin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051231</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>20; 400</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0904-6443-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0904-6443-01) </PackageDescription>
    <NDC11Code>00904-6443-01</NDC11Code>
    <ProductNDC>0904-6443</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA086242</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150514</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0904-6449-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6449-01)</PackageDescription>
    <NDC11Code>00904-6449-01</NDC11Code>
    <ProductNDC>0904-6449</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
    <NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200270</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-30</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0904-6450-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6450-01)</PackageDescription>
    <NDC11Code>00904-6450-01</NDC11Code>
    <ProductNDC>0904-6450</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
    <NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200495</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-30</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0904-6451-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6451-01)</PackageDescription>
    <NDC11Code>00904-6451-01</NDC11Code>
    <ProductNDC>0904-6451</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
    <NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200495</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-30</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0904-7116-01</NDCCode>
    <PackageDescription>30 CUP in 1 CASE (0904-7116-01)  / 10 mL in 1 CUP (0904-7116-66) </PackageDescription>
    <NDC11Code>00904-7116-01</NDC11Code>
    <ProductNDC>0904-7116</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbamazepine</ProprietaryName>
    <NonProprietaryName>Carbamazepine</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076729</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>CARBAMAZEPINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 2.Generalized tonic-clonic seizures (grand mal)., 3 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .</IndicationAndUsage>
    <Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 and 200 mg, tablets of 200 mg, extended-release tablets of 100 mg, 200 mg, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients:Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg –ammonio methacrylate copolymer, croscarmellose sodium, diethyl phthalate, FD&amp;C red no. 40 lake, magnesium stearate, microcrystalline cellulose, natural cherry flavor, pregelatinized maize starch and sorbitol. Carbamazepine Tablets USP, 200 mg– ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose. Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg– ammonio methacrylate copolymer, corn starch, diethyl phthalate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Carbamazepine Oral Suspension USP, 100 mg/5 mL– citric acid monohydrate, FD&amp;C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7332-17</NDCCode>
    <PackageDescription>25 POUCH in 1 CARTON (0904-7332-17)  / 1 SUPPOSITORY in 1 POUCH (0904-7332-01) </PackageDescription>
    <NDC11Code>00904-7332-17</NDC11Code>
    <ProductNDC>0904-7332</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Glycerin</ProprietaryName>
    <NonProprietaryName>Glycerin Suppository</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20240713</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>MAJOR� PHARMACEUTICALS</LabelerName>
    <SubstanceName>GLYCERIN</SubstanceName>
    <StrengthNumber>1.2</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of occasional constipation. This product usually produces a bowel movement in 1/4 to 1 hour.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-7333-17</NDCCode>
    <PackageDescription>25 POUCH in 1 CARTON (0904-7333-17)  / 1 SUPPOSITORY in 1 POUCH (0904-7333-01) </PackageDescription>
    <NDC11Code>00904-7333-17</NDC11Code>
    <ProductNDC>0904-7333</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Glycerin</ProprietaryName>
    <NonProprietaryName>Glycerin Suppository</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20240703</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>MAJOR� PHARMACEUTICALS</LabelerName>
    <SubstanceName>GLYCERIN</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240703</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of occasional constipation. This product usually produces a bowel movement in ¼ to 1 hour.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-7342-01</NDCCode>
    <PackageDescription>1 PATCH in 1 POUCH (0904-7342-01)  / 9 g in 1 PATCH</PackageDescription>
    <NDC11Code>00904-7342-01</NDC11Code>
    <ProductNDC>0904-7342</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Major Arthritis Pain Relief Patch</ProprietaryName>
    <NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230401</StartMarketingDate>
    <EndMarketingDate>20260425</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>3; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260425</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: ■ strains ■ sprains ■ simple backache ■ arthritis ■ bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0904-7470-01</NDCCode>
    <PackageDescription>30 CUP, UNIT-DOSE in 1 CASE (0904-7470-01)  / 10 mL in 1 CUP, UNIT-DOSE (0904-7470-66) </PackageDescription>
    <NDC11Code>00904-7470-01</NDC11Code>
    <ProductNDC>0904-7470</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sucralfate</ProprietaryName>
    <NonProprietaryName>Sucralfate Oral Suspension</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211884</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>SUCRALFATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Aluminum Complex [EPC], Organometallic Compounds [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sucralfate Oral Suspension is indicated in the short-term (up to 8weeks) treatment of active duodenal ulcer.</IndicationAndUsage>
    <Description>Sucralfate Oral Suspension contains sucralfate and sucralfate is an β-D-glucopyranoside, α-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate Oral Suspension also contains: colloidal silicon dioxide, FD&amp;C Red No. 40, wild cherry flavor (contains propylene glycol, artificial flavors, natural flavors, ethyl alcohol), glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion, sorbitol solution. Therapeutic category: antiulcer.</Description>
  </NDC>
  <NDC>
    <NDCCode>11071-904-01</NDCCode>
    <PackageDescription>40000 TABLET in 1 DRUM (11071-904-01)</PackageDescription>
    <NDC11Code>11071-0904-01</NDC11Code>
    <ProductNDC>11071-904</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20121022</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Eisai Co., Ltd.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2019-05-10</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11822-0904-1</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (11822-0904-1)  / 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>11822-0904-01</NDC11Code>
    <ProductNDC>11822-0904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nictoine Gum</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>GUM, CHEWING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170117</StartMarketingDate>
    <EndMarketingDate>20260930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206394</ApplicationNumber>
    <LabelerName>Rite Aid Corporation</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170117</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-904-01</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-904-01) </PackageDescription>
    <NDC11Code>16714-0904-01</NDC11Code>
    <ProductNDC>16714-904</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190410</StartMarketingDate>
    <EndMarketingDate>20240630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091272</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190410</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine hydrochloride extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine hydrochloride extended-release tablets are formulated as an extended-release tablet for once-a-day oral administration. Venlafaxine hydrochloride extended-release tablets use a hydrogel-based technology to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system comprises of a bilayer tablet surrounded by a partially permeable coat. The bilayer tablet core consists of one colored swellable layer and a second drug containing layer. On contact of tablet with aqueous medium, the soluble components of the partially permeable membrane dissolve. Imbibition of the aqueous medium by the swellable layer causes it to swell rapidly. This exerts mechanical pressure on the coating causing it to rupture. The coating is removed from the swellable layer side only to expose a pre-defined surface area from which release of the drug occurs. The controlled rate of drug delivery is a function of controlled surface area and the excipients of the drug layer.The biologically inert fragments of the coating may remain intact and may be eliminated in the feces.Each extended-release coated bilayer tablet contains venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of hypromellose, povidone, lactose monohydrate, methacrylic acid copolymer, talc, magnesium stearate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, sodium lauryl sulfate, FD &amp; C Red No. 40 Aluminum Lake, ethyl cellulose aqueous dispersion, mannitol, dibutyl sebacate, triethyl citrate, polysorbate 20, polyethylene glycol, polysorbate 80, and polyvinyl alcohol.  Imprinting ink contains shellac glaze, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol and ammonium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-904-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (31722-904-01)</PackageDescription>
    <NDC11Code>31722-0904-01</NDC11Code>
    <ProductNDC>31722-904</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204597</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine  and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax® .</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3- [(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&amp;C Blue #1, FD&amp;C Red #3, and titanium dioxide. In addition 20 mg capsules also contains D&amp;C Yellow #10 and 10 mg capsules also contains FD&amp;C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-904-01</NDCCode>
    <PackageDescription>1.5 mL in 1 POUCH (37000-904-01)</PackageDescription>
    <NDC11Code>37000-0904-01</NDC11Code>
    <ProductNDC>37000-904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dolce And Gabbana The Lift Foundation Bronze 144</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140405</StartMarketingDate>
    <EndMarketingDate>20170401</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>29.9; 25.2</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-04-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>37662-0904-1</NDCCode>
    <PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-0904-1) </PackageDescription>
    <NDC11Code>37662-0904-01</NDC11Code>
    <ProductNDC>37662-0904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kalmia Latifolia</ProprietaryName>
    <NonProprietaryName>Kalmia Latifolia</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220714</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>KALMIA LATIFOLIA LEAF</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_M]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>37835-904-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37835-904-01)  / 28.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>37835-0904-01</NDC11Code>
    <ProductNDC>37835-904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triple Antibiotic Plus Pain Relief</ProprietaryName>
    <NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>Bi-Mart</LabelerName>
    <SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>400; 5; 10000; 10</StrengthNumber>
    <StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis &amp; Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent infection and for the temporary relief of pain in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42385-904-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42385-904-01) </PackageDescription>
    <NDC11Code>42385-0904-01</NDC11Code>
    <ProductNDC>42385-904</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209882</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43742-0904-1</NDCCode>
    <PackageDescription>1 DOSE PACK in 1 CARTON (43742-0904-1)  &gt; 1 KIT in 1 DOSE PACK *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0905-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0909-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0908-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0907-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0906-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0914-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0913-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0912-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0911-1)  *  2 mL in 1 VIAL, SINGLE-DOSE (43742-0910-1) </PackageDescription>
    <NDC11Code>43742-0904-01</NDC11Code>
    <ProductNDC>43742-0904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bartonella Kit</ProprietaryName>
    <NonProprietaryName>Bartonella Bacilliformis, Bartonella Clarridgeiae, Bartonella Elizabethae, Bartonella Henselae, Bartonella Quintana, Bartonella Vinsonii, Bartonella Washoensis</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20161128</StartMarketingDate>
    <EndMarketingDate>20221023</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Deseret Biologicals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20161128</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221023</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>44911-0904-1</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, DROPPER (44911-0904-1) </PackageDescription>
    <NDC11Code>44911-0904-01</NDC11Code>
    <ProductNDC>44911-0904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Renatone</ProprietaryName>
    <NonProprietaryName>Berberis Vulgaris, Solidago Virgaurea, Cantharis, Arsenicum Album, Coccus Cacti, Lycopodium Clavatum, Phosphorus, Senecio Aureus, Staphysagria</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260227</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Energique, Inc.</LabelerName>
    <SubstanceName>BERBERIS VULGARIS ROOT BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; LYTTA VESICATORIA; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PACKERA AUREA WHOLE; STAPHISAGRIA MACROSPERMA SEED</SubstanceName>
    <StrengthNumber>3; 3; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>May temporarily relieve urine that is scanty, dark, and offensive, pain in the back, and sensation as if some urine remained after urinating.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48292-0904-1</NDCCode>
    <PackageDescription>1 kg in 1 CARTON (48292-0904-1) </PackageDescription>
    <NDC11Code>48292-0904-01</NDC11Code>
    <ProductNDC>48292-0904</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Albuterol Salbutamol Base</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150213</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SICOR Societa' Italiana Corticosteroidi s.r.l.</LabelerName>
    <SubstanceName>ALBUTEROL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-02-01</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>13-FEB-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>49967-904-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (49967-904-01)  / 32 mL in 1 TUBE</PackageDescription>
    <NDC11Code>49967-0904-01</NDC11Code>
    <ProductNDC>49967-904</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>It Cosmetics Your Skin But Better Cc Plus Color Correcting Broad Spectrum Spf 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral Rich</ProprietaryName>
    <NonProprietaryName>Homosalate, Octisalate And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M</ApplicationNumber>
    <LabelerName>L�Oreal USA Products Inc</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTISALATE</SubstanceName>
    <StrengthNumber>100; 40; 50</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ helps prevent sunburn. ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0904-5694-01</NDCCode><ProprietaryName>Major Extra Strength Cold And Hot Pain Relief Therapy</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>0591-5694-01</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-5694-1</NDCCode><ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide 20/12.5</NonProprietaryName></NDC><NDC><NDCCode>50090-5694-0</NDCCode><ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide 20/12.5</NonProprietaryName></NDC><NDC><NDCCode>0441-0904-01</NDCCode><NonProprietaryName>Tripalmitin</NonProprietaryName></NDC><NDC><NDCCode>0904-5415-01</NDCCode><ProprietaryName>Miconazole 3 Combination Pack</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>0904-5758-01</NDCCode><ProprietaryName>Mucus Relief</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>0904-5792-01</NDCCode><ProprietaryName>Sinus Congestion Pe</ProprietaryName><NonProprietaryName>Guaifenesin And Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>0904-6013-01</NDCCode><ProprietaryName>Mucus Relief Dm</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr And Guiafenesin</NonProprietaryName></NDC><NDC><NDCCode>0904-6443-01</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0904-6449-01</NDCCode><ProprietaryName>Isosorbide Mononitrate</ProprietaryName><NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName></NDC><NDC><NDCCode>0904-6450-01</NDCCode><ProprietaryName>Isosorbide Mononitrate</ProprietaryName><NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName></NDC><NDC><NDCCode>0904-6451-01</NDCCode><ProprietaryName>Isosorbide Mononitrate</ProprietaryName><NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName></NDC><NDC><NDCCode>0904-7116-01</NDCCode><ProprietaryName>Carbamazepine</ProprietaryName><NonProprietaryName>Carbamazepine</NonProprietaryName></NDC><NDC><NDCCode>0904-7332-17</NDCCode><ProprietaryName>Glycerin</ProprietaryName><NonProprietaryName>Glycerin Suppository</NonProprietaryName></NDC><NDC><NDCCode>0904-7333-17</NDCCode><ProprietaryName>Glycerin</ProprietaryName><NonProprietaryName>Glycerin Suppository</NonProprietaryName></NDC><NDC><NDCCode>0904-7342-01</NDCCode><ProprietaryName>Major Arthritis Pain Relief Patch</ProprietaryName><NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>0904-7470-01</NDCCode><ProprietaryName>Sucralfate</ProprietaryName><NonProprietaryName>Sucralfate Oral Suspension</NonProprietaryName></NDC><NDC><NDCCode>11071-904-01</NDCCode><NonProprietaryName>Perampanel</NonProprietaryName></NDC><NDC><NDCCode>11822-0904-1</NDCCode><ProprietaryName>Nictoine Gum</ProprietaryName><NonProprietaryName>Nicotine Polacrilex</NonProprietaryName></NDC><NDC><NDCCode>16714-904-01</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>31722-904-01</NDCCode><ProprietaryName>Fluoxetine</ProprietaryName><NonProprietaryName>Fluoxetine</NonProprietaryName></NDC><NDC><NDCCode>37000-904-01</NDCCode><ProprietaryName>Dolce And Gabbana The Lift Foundation Bronze 144</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>37662-0904-1</NDCCode><ProprietaryName>Kalmia Latifolia</ProprietaryName><NonProprietaryName>Kalmia Latifolia</NonProprietaryName></NDC><NDC><NDCCode>37835-904-01</NDCCode><ProprietaryName>Triple Antibiotic Plus Pain Relief</ProprietaryName><NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42385-904-01</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43742-0904-1</NDCCode><ProprietaryName>Bartonella Kit</ProprietaryName><NonProprietaryName>Bartonella Bacilliformis, Bartonella Clarridgeiae, Bartonella Elizabethae, Bartonella Henselae, Bartonella Quintana, Bartonella Vinsonii, Bartonella Washoensis</NonProprietaryName></NDC><NDC><NDCCode>44911-0904-1</NDCCode><ProprietaryName>Renatone</ProprietaryName><NonProprietaryName>Berberis Vulgaris, Solidago Virgaurea, Cantharis, Arsenicum Album, Coccus Cacti, Lycopodium Clavatum, Phosphorus, Senecio Aureus, Staphysagria</NonProprietaryName></NDC><NDC><NDCCode>48292-0904-1</NDCCode><NonProprietaryName>Albuterol Salbutamol Base</NonProprietaryName></NDC><NDC><NDCCode>49967-904-01</NDCCode><ProprietaryName>It Cosmetics Your Skin But Better Cc Plus Color Correcting Broad Spectrum Spf 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral Rich</ProprietaryName><NonProprietaryName>Homosalate, Octisalate And Octocrylene</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",
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      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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