RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "68428-386-12",
      "PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-386-12) ",
      "NDC11Code": "68428-0386-12",
      "ProductNDC": "68428-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ferrum Picricum",
      "NonProprietaryName": "Ferric Picrate",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "FERRIC PICRATE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "33342-386-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-386-12)  / 10 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "33342-0386-12",
      "ProductNDC": "33342-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211137",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251209",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate 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. Treatment:  Doxycycline is indicated for the treatment of the following infections:   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) caused by 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.   Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.   Nongonococcal urethritis caused by Ureaplasma urealyticum.   Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:   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.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.  Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:   Escherichia coli.   Enterobacter aerogenes.   Shigella species.   Acinetobacter species.   Respiratory tract infections caused by Haemophilus influenzae.   Respiratory tract and urinary tract infections caused by Klebsiella species.  Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:   Upper respiratory infections caused by Streptococcus pneumoniae.   Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.  When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:  Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.   Yaws caused by Treponema pallidum subspecies pertenue.   Listeriosis due to Listeria monocytogenes.   Vincent’s infection caused by Fusobacterium fusiforme.   Actinomycosis caused by Actinomyces israelii.   Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.  In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).",
      "Description": "Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration.  The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate.  Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.  Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide."
    },
    {
      "NDCCode": "61269-386-12",
      "PackageDescription": "10 BLISTER PACK in 1 BOX (61269-386-12)  / 12 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "61269-0386-12",
      "ProductNDC": "61269-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bismuth Subcitrate Potassium, Metronidazole And Tetracycline Hydrochloride",
      "NonProprietaryName": "Bismuth Subcitrate Potassium, Metronidazole And Tetracycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250701",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA050786",
      "LabelerName": "H2-Pharma, LLC",
      "SubstanceName": "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE",
      "StrengthNumber": "140; 125; 125",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250701",
      "SamplePackage": "N",
      "Description": "Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: 1 bismuth subcitrate potassium, 140 mg, 2 metronidazole, 125 mg, 3 smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg."
    },
    {
      "NDCCode": "77368-386-12",
      "PackageDescription": "355 mL in 1 BOTTLE (77368-386-12) ",
      "NDC11Code": "77368-0386-12",
      "ProductNDC": "77368-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nurinse",
      "NonProprietaryName": "Hand Sanitizer Hocl",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200505",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "NuGenTec",
      "SubstanceName": "HYPOCHLOROUS ACID",
      "StrengthNumber": ".000385",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200505",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "79903-386-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (79903-386-24)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "79903-0386-24",
      "ProductNDC": "79903-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equate Maximum Strength Daytime Severe Cold And Flu Softgels",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250910",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "WALMART INC.",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 10; 200; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250910",
      "SamplePackage": "N",
      "IndicationAndUsage": " temporarily relieves common cold/flu symptoms:   nasal congestion  sinus congestion & pressure   cough due to minor throat & bronchial irritation   minor aches & pains  headache  fever   sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
    },
    {
      "NDCCode": "68428-386-03",
      "PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-386-03) ",
      "NDC11Code": "68428-0386-03",
      "ProductNDC": "68428-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ferrum Picricum",
      "NonProprietaryName": "Ferric Picrate",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "FERRIC PICRATE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-386-05",
      "PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-386-05) ",
      "NDC11Code": "68428-0386-05",
      "ProductNDC": "68428-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ferrum Picricum",
      "NonProprietaryName": "Ferric Picrate",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "FERRIC PICRATE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-386-06",
      "PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-386-06) ",
      "NDC11Code": "68428-0386-06",
      "ProductNDC": "68428-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ferrum Picricum",
      "NonProprietaryName": "Ferric Picrate",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "FERRIC PICRATE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-386-11",
      "PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-386-11) ",
      "NDC11Code": "68428-0386-11",
      "ProductNDC": "68428-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ferrum Picricum",
      "NonProprietaryName": "Ferric Picrate",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "FERRIC PICRATE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0046-2575-12",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-2575-12)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "00046-2575-12",
      "ProductNDC": "0046-2575",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Premphase",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120301",
      "SamplePackage": "N",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
    },
    {
      "NDCCode": "0597-0035-10",
      "PackageDescription": "2 VIAL, GLASS in 1 CARTON (0597-0035-10)  / 7.5 mL in 1 VIAL, GLASS",
      "NDC11Code": "00597-0035-10",
      "ProductNDC": "0597-0035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spevigo",
      "NonProprietaryName": "Spesolimab-sbzo",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220901",
      "EndMarketingDate": "20271130",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761244",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "SPESOLIMAB",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220901",
      "EndMarketingDatePackage": "20271130",
      "SamplePackage": "N",
      "IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
      "Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
    },
    {
      "NDCCode": "0597-0620-20",
      "PackageDescription": "2 SYRINGE in 1 CARTON (0597-0620-20)  / 150 INJECTION in 1 SYRINGE (0597-0620-10) ",
      "NDC11Code": "00597-0620-20",
      "ProductNDC": "0597-0620",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spevigo",
      "NonProprietaryName": "Spesolimab-sbzo",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240318",
      "EndMarketingDate": "20270831",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761244",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "SPESOLIMAB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240318",
      "EndMarketingDatePackage": "20270831",
      "SamplePackage": "N",
      "IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
      "Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
    },
    {
      "NDCCode": "0597-7705-41",
      "PackageDescription": "1 SYRINGE in 1 CARTON (0597-7705-41)  / 300 INJECTION in 1 SYRINGE (0597-7705-38) ",
      "NDC11Code": "00597-7705-41",
      "ProductNDC": "0597-7705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spevigo",
      "NonProprietaryName": "Spesolimab-sbzo",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250528",
      "EndMarketingDate": "20270430",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761244",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "SPESOLIMAB",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250528",
      "EndMarketingDatePackage": "20270430",
      "SamplePackage": "N",
      "IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
      "Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
    },
    {
      "NDCCode": "0597-7705-72",
      "PackageDescription": "2 SYRINGE in 1 CARTON (0597-7705-72)  / 300 INJECTION in 1 SYRINGE (0597-7705-38) ",
      "NDC11Code": "00597-7705-72",
      "ProductNDC": "0597-7705",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spevigo",
      "NonProprietaryName": "Spesolimab-sbzo",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250528",
      "EndMarketingDate": "20270430",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761244",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "SPESOLIMAB",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250528",
      "EndMarketingDatePackage": "20270430",
      "SamplePackage": "N",
      "IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
      "Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
    },
    {
      "NDCCode": "10812-386-01",
      "PackageDescription": "5.5 g in 1 CASE (10812-386-01)",
      "NDC11Code": "10812-0386-01",
      "ProductNDC": "10812-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Mineral Sheers",
      "ProprietaryNameSuffix": "Spf20 - Natural Beige 60",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110620",
      "EndMarketingDate": "20160801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Neutrogena Corporation",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "13668-386-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (13668-386-05) ",
      "NDC11Code": "13668-0386-05",
      "ProductNDC": "13668-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161026",
      "EndMarketingDate": "20250831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203580",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5; 12.5; 40",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161026",
      "EndMarketingDatePackage": "20250831",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel 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": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.  Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
    },
    {
      "NDCCode": "13668-386-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (13668-386-30) ",
      "NDC11Code": "13668-0386-30",
      "ProductNDC": "13668-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161026",
      "EndMarketingDate": "20250831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203580",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5; 12.5; 40",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161026",
      "EndMarketingDatePackage": "20250831",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel 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": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.  Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
    },
    {
      "NDCCode": "13668-386-74",
      "PackageDescription": "100 TABLET in 1 CARTON (13668-386-74) ",
      "NDC11Code": "13668-0386-74",
      "ProductNDC": "13668-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203580",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5; 12.5; 40",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20161026",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "13668-386-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (13668-386-90) ",
      "NDC11Code": "13668-0386-90",
      "ProductNDC": "13668-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161026",
      "EndMarketingDate": "20250831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203580",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5; 12.5; 40",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161026",
      "EndMarketingDatePackage": "20250831",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel 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": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.  Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
    },
    {
      "NDCCode": "16103-386-08",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (16103-386-08) ",
      "NDC11Code": "16103-0386-08",
      "ProductNDC": "16103-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Meclizine",
      "NonProprietaryName": "Meclizine Hcl 12.5 Mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "Pharbest Pharmaceuticals, Inc.",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180201",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "16103-386-11",
      "PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (16103-386-11) ",
      "NDC11Code": "16103-0386-11",
      "ProductNDC": "16103-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Meclizine",
      "NonProprietaryName": "Meclizine Hcl 12.5 Mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "Pharbest Pharmaceuticals, Inc.",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180201",
      "SamplePackage": "N",
      "IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
    },
    {
      "NDCCode": "33342-386-08",
      "PackageDescription": "50 CAPSULE in 1 BOTTLE (33342-386-08) ",
      "NDC11Code": "33342-0386-08",
      "ProductNDC": "33342-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211137",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251209",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate 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. Treatment:  Doxycycline is indicated for the treatment of the following infections:   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) caused by 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.   Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.   Nongonococcal urethritis caused by Ureaplasma urealyticum.   Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:   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.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.  Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:   Escherichia coli.   Enterobacter aerogenes.   Shigella species.   Acinetobacter species.   Respiratory tract infections caused by Haemophilus influenzae.   Respiratory tract and urinary tract infections caused by Klebsiella species.  Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:   Upper respiratory infections caused by Streptococcus pneumoniae.   Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.  When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:  Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.   Yaws caused by Treponema pallidum subspecies pertenue.   Listeriosis due to Listeria monocytogenes.   Vincent’s infection caused by Fusobacterium fusiforme.   Actinomycosis caused by Actinomyces israelii.   Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.  In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).",
      "Description": "Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration.  The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate.  Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.  Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide."
    },
    {
      "NDCCode": "33342-386-15",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (33342-386-15) ",
      "NDC11Code": "33342-0386-15",
      "ProductNDC": "33342-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211137",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251209",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate 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. Treatment:  Doxycycline is indicated for the treatment of the following infections:   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) caused by 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.   Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.   Nongonococcal urethritis caused by Ureaplasma urealyticum.   Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:   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.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.  Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:   Escherichia coli.   Enterobacter aerogenes.   Shigella species.   Acinetobacter species.   Respiratory tract infections caused by Haemophilus influenzae.   Respiratory tract and urinary tract infections caused by Klebsiella species.  Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:   Upper respiratory infections caused by Streptococcus pneumoniae.   Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.  When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:  Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.   Yaws caused by Treponema pallidum subspecies pertenue.   Listeriosis due to Listeria monocytogenes.   Vincent’s infection caused by Fusobacterium fusiforme.   Actinomycosis caused by Actinomyces israelii.   Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.  In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).",
      "Description": "Doxycycline hyclate capsules are an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration.  The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8.HCl)2. C2H6O.H2O and the molecular weight is 1025.87. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate.  Doxycycline is a light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.  Inert ingredients in the capsule formulations are: colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The hard gelatin capsules contain gelatin, sodium lauryl sulfate, FD & C Blue 1 and titanium dioxide. The capsules are printed with edible ink containing shellac, and black iron oxide."
    },
    {
      "NDCCode": "37808-386-27",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (37808-386-27)  > 16 TABLET in 1 BLISTER PACK",
      "NDC11Code": "37808-0386-27",
      "ProductNDC": "37808-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sleep-aid",
      "NonProprietaryName": "Doxylamine Succinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020411",
      "EndMarketingDate": "20191201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040564",
      "LabelerName": "H E B",
      "SubstanceName": "DOXYLAMINE SUCCINATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20020411",
      "EndMarketingDatePackage": "20191201",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43547-386-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (43547-386-09) ",
      "NDC11Code": "43547-0386-09",
      "ProductNDC": "43547-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fosinopril Sodium",
      "NonProprietaryName": "Fosinopirl Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205670",
      "LabelerName": "Solco Healthcare LLC",
      "SubstanceName": "FOSINOPRIL SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION). In using fosinopril sodium, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Head and Neck Angioedema and Intestinal Angioedema).",
      "Description": "Fosinopril sodium is the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-. Fosinopril sodium is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. C30 H45NNaO7P                     M.W. 585.65. Fosinopril sodium, USP, is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose monohydrate, microcrystalline cellulose, povidone, and sodium stearyl fumarate."
    },
    {
      "NDCCode": "43547-386-11",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (43547-386-11) ",
      "NDC11Code": "43547-0386-11",
      "ProductNDC": "43547-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fosinopril Sodium",
      "NonProprietaryName": "Fosinopirl Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205670",
      "LabelerName": "Solco Healthcare LLC",
      "SubstanceName": "FOSINOPRIL SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION). In using fosinopril sodium, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Head and Neck Angioedema and Intestinal Angioedema).",
      "Description": "Fosinopril sodium is the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-. Fosinopril sodium is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. C30 H45NNaO7P                     M.W. 585.65. Fosinopril sodium, USP, is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose monohydrate, microcrystalline cellulose, povidone, and sodium stearyl fumarate."
    },
    {
      "NDCCode": "49643-386-05",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-386-05) ",
      "NDC11Code": "49643-0386-05",
      "ProductNDC": "49643-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Timothy Grass",
      "NonProprietaryName": "Phleum Pratense",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19961202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102221",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (13). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.",
      "Description": "Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense). The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration. The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response (12). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts."
    },
    {
      "NDCCode": "49643-386-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-386-10) ",
      "NDC11Code": "49643-0386-10",
      "ProductNDC": "49643-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Timothy Grass",
      "NonProprietaryName": "Phleum Pratense",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19961202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102221",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (13). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.",
      "Description": "Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense). The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration. The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response (12). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts."
    },
    {
      "NDCCode": "49643-386-30",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-386-30) ",
      "NDC11Code": "49643-0386-30",
      "ProductNDC": "49643-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Timothy Grass",
      "NonProprietaryName": "Phleum Pratense",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19961202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102221",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (13). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.",
      "Description": "Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense). The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration. The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response (12). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts."
    },
    {
      "NDCCode": "49643-386-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49643-386-50) ",
      "NDC11Code": "49643-0386-50",
      "ProductNDC": "49643-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Timothy Grass",
      "NonProprietaryName": "Phleum Pratense",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19961202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102221",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (13). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.",
      "Description": "Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense). The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration. The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response (12). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"68428-386-12","ProprietaryName":"Ferrum Picricum","NonProprietaryName":"Ferric Picrate"},{"NDCCode":"33342-386-12","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"61269-386-12","ProprietaryName":"Bismuth Subcitrate Potassium, Metronidazole And Tetracycline Hydrochloride","NonProprietaryName":"Bismuth Subcitrate Potassium, Metronidazole And Tetracycline Hydrochloride"},{"NDCCode":"77368-386-12","ProprietaryName":"Nurinse","NonProprietaryName":"Hand Sanitizer Hocl"},{"NDCCode":"79903-386-24","ProprietaryName":"Equate Maximum Strength Daytime Severe Cold And Flu Softgels","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"},{"NDCCode":"68428-386-03","ProprietaryName":"Ferrum Picricum","NonProprietaryName":"Ferric Picrate"},{"NDCCode":"68428-386-05","ProprietaryName":"Ferrum Picricum","NonProprietaryName":"Ferric Picrate"},{"NDCCode":"68428-386-06","ProprietaryName":"Ferrum Picricum","NonProprietaryName":"Ferric Picrate"},{"NDCCode":"68428-386-11","ProprietaryName":"Ferrum Picricum","NonProprietaryName":"Ferric Picrate"},{"NDCCode":"0046-2575-12","ProprietaryName":"Premphase","NonProprietaryName":"Conjugated Estrogens And Medroxyprogesterone Acetate"},{"NDCCode":"0597-0035-10","ProprietaryName":"Spevigo","NonProprietaryName":"Spesolimab-sbzo"},{"NDCCode":"0597-0620-20","ProprietaryName":"Spevigo","NonProprietaryName":"Spesolimab-sbzo"},{"NDCCode":"0597-7705-41","ProprietaryName":"Spevigo","NonProprietaryName":"Spesolimab-sbzo"},{"NDCCode":"0597-7705-72","ProprietaryName":"Spevigo","NonProprietaryName":"Spesolimab-sbzo"},{"NDCCode":"10812-386-01","ProprietaryName":"Neutrogena Mineral Sheers","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"13668-386-05","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg"},{"NDCCode":"13668-386-30","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg"},{"NDCCode":"13668-386-74","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg"},{"NDCCode":"13668-386-90","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg"},{"NDCCode":"16103-386-08","ProprietaryName":"Meclizine","NonProprietaryName":"Meclizine Hcl 12.5 Mg"},{"NDCCode":"16103-386-11","ProprietaryName":"Meclizine","NonProprietaryName":"Meclizine Hcl 12.5 Mg"},{"NDCCode":"33342-386-08","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"33342-386-15","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"37808-386-27","ProprietaryName":"Sleep-aid","NonProprietaryName":"Doxylamine Succinate"},{"NDCCode":"43547-386-09","ProprietaryName":"Fosinopril Sodium","NonProprietaryName":"Fosinopirl Sodium"},{"NDCCode":"43547-386-11","ProprietaryName":"Fosinopril Sodium","NonProprietaryName":"Fosinopirl Sodium"},{"NDCCode":"49643-386-05","ProprietaryName":"Standardized Timothy Grass","NonProprietaryName":"Phleum Pratense"},{"NDCCode":"49643-386-10","ProprietaryName":"Standardized Timothy Grass","NonProprietaryName":"Phleum Pratense"},{"NDCCode":"49643-386-30","ProprietaryName":"Standardized Timothy Grass","NonProprietaryName":"Phleum Pratense"},{"NDCCode":"49643-386-50","ProprietaryName":"Standardized Timothy Grass","NonProprietaryName":"Phleum Pratense"}]}
                    

<NDCList><NDC><NDCCode>68428-386-12</NDCCode><ProprietaryName>Ferrum Picricum</ProprietaryName><NonProprietaryName>Ferric Picrate</NonProprietaryName></NDC><NDC><NDCCode>33342-386-12</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>61269-386-12</NDCCode><ProprietaryName>Bismuth Subcitrate Potassium, Metronidazole And Tetracycline Hydrochloride</ProprietaryName><NonProprietaryName>Bismuth Subcitrate Potassium, Metronidazole And Tetracycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>77368-386-12</NDCCode><ProprietaryName>Nurinse</ProprietaryName><NonProprietaryName>Hand Sanitizer Hocl</NonProprietaryName></NDC><NDC><NDCCode>79903-386-24</NDCCode><ProprietaryName>Equate Maximum Strength Daytime Severe Cold And Flu Softgels</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68428-386-03</NDCCode><ProprietaryName>Ferrum Picricum</ProprietaryName><NonProprietaryName>Ferric Picrate</NonProprietaryName></NDC><NDC><NDCCode>68428-386-05</NDCCode><ProprietaryName>Ferrum Picricum</ProprietaryName><NonProprietaryName>Ferric Picrate</NonProprietaryName></NDC><NDC><NDCCode>68428-386-06</NDCCode><ProprietaryName>Ferrum Picricum</ProprietaryName><NonProprietaryName>Ferric Picrate</NonProprietaryName></NDC><NDC><NDCCode>68428-386-11</NDCCode><ProprietaryName>Ferrum Picricum</ProprietaryName><NonProprietaryName>Ferric Picrate</NonProprietaryName></NDC><NDC><NDCCode>0046-2575-12</NDCCode><ProprietaryName>Premphase</ProprietaryName><NonProprietaryName>Conjugated Estrogens And Medroxyprogesterone Acetate</NonProprietaryName></NDC><NDC><NDCCode>0597-0035-10</NDCCode><ProprietaryName>Spevigo</ProprietaryName><NonProprietaryName>Spesolimab-sbzo</NonProprietaryName></NDC><NDC><NDCCode>0597-0620-20</NDCCode><ProprietaryName>Spevigo</ProprietaryName><NonProprietaryName>Spesolimab-sbzo</NonProprietaryName></NDC><NDC><NDCCode>0597-7705-41</NDCCode><ProprietaryName>Spevigo</ProprietaryName><NonProprietaryName>Spesolimab-sbzo</NonProprietaryName></NDC><NDC><NDCCode>0597-7705-72</NDCCode><ProprietaryName>Spevigo</ProprietaryName><NonProprietaryName>Spesolimab-sbzo</NonProprietaryName></NDC><NDC><NDCCode>10812-386-01</NDCCode><ProprietaryName>Neutrogena Mineral Sheers</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>13668-386-05</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg</NonProprietaryName></NDC><NDC><NDCCode>13668-386-30</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg</NonProprietaryName></NDC><NDC><NDCCode>13668-386-74</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg</NonProprietaryName></NDC><NDC><NDCCode>13668-386-90</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg</NonProprietaryName></NDC><NDC><NDCCode>16103-386-08</NDCCode><ProprietaryName>Meclizine</ProprietaryName><NonProprietaryName>Meclizine Hcl 12.5 Mg</NonProprietaryName></NDC><NDC><NDCCode>16103-386-11</NDCCode><ProprietaryName>Meclizine</ProprietaryName><NonProprietaryName>Meclizine Hcl 12.5 Mg</NonProprietaryName></NDC><NDC><NDCCode>33342-386-08</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>33342-386-15</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>37808-386-27</NDCCode><ProprietaryName>Sleep-aid</ProprietaryName><NonProprietaryName>Doxylamine Succinate</NonProprietaryName></NDC><NDC><NDCCode>43547-386-09</NDCCode><ProprietaryName>Fosinopril Sodium</ProprietaryName><NonProprietaryName>Fosinopirl Sodium</NonProprietaryName></NDC><NDC><NDCCode>43547-386-11</NDCCode><ProprietaryName>Fosinopril Sodium</ProprietaryName><NonProprietaryName>Fosinopirl Sodium</NonProprietaryName></NDC><NDC><NDCCode>49643-386-05</NDCCode><ProprietaryName>Standardized Timothy Grass</ProprietaryName><NonProprietaryName>Phleum Pratense</NonProprietaryName></NDC><NDC><NDCCode>49643-386-10</NDCCode><ProprietaryName>Standardized Timothy Grass</ProprietaryName><NonProprietaryName>Phleum Pratense</NonProprietaryName></NDC><NDC><NDCCode>49643-386-30</NDCCode><ProprietaryName>Standardized Timothy Grass</ProprietaryName><NonProprietaryName>Phleum Pratense</NonProprietaryName></NDC><NDC><NDCCode>49643-386-50</NDCCode><ProprietaryName>Standardized Timothy Grass</ProprietaryName><NonProprietaryName>Phleum Pratense</NonProprietaryName></NDC></NDCList>