{
"NDC": [
{
"NDCCode": "81996-244-08",
"PackageDescription": "228 g in 1 JAR (81996-244-08) ",
"NDC11Code": "81996-0244-08",
"ProductNDC": "81996-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nuturna Arthritis Intensive Concentrate For Pain Relief And Recovery",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201122",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Nuturna International LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "3.7",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "81996-244-02",
"PackageDescription": "57 g in 1 JAR (81996-244-02) ",
"NDC11Code": "81996-0244-02",
"ProductNDC": "81996-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nuturna Arthritis Intensive Concentrate For Pain Relief And Recovery",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201122",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Nuturna International LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "3.7",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "81996-244-04",
"PackageDescription": "114 g in 1 JAR (81996-244-04) ",
"NDC11Code": "81996-0244-04",
"ProductNDC": "81996-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nuturna Arthritis Intensive Concentrate For Pain Relief And Recovery",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201122",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Nuturna International LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "3.7",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "13537-244-08",
"PackageDescription": "1 TUBE in 1 BOX (13537-244-08) > 3 mL in 1 TUBE (13537-244-07)",
"NDC11Code": "13537-0244-08",
"ProductNDC": "13537-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Natural Finish Moisturizing Foundation Spf 25",
"ProprietaryNameSuffix": "(claire 4) - Beige",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".065; .016",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-244-08",
"PackageDescription": "1 TUBE in 1 BOX (14783-244-08) > 3 mL in 1 TUBE (14783-244-07)",
"NDC11Code": "14783-0244-08",
"ProductNDC": "14783-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Natural Finish Moisturizing Foundation Spf 25",
"ProprietaryNameSuffix": "(claire 4) - Beige",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".065; .016",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "50580-244-08",
"PackageDescription": "12 VIAL, PLASTIC in 1 CARTON (50580-244-08) > 8 TABLET, COATED in 1 VIAL, PLASTIC",
"NDC11Code": "50580-0244-08",
"ProductNDC": "50580-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "62217-244-08",
"PackageDescription": "88 g in 1 CAN (62217-244-08) ",
"NDC11Code": "62217-0244-08",
"ProductNDC": "62217-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth Sun Town City Mineral Spf 30 Sunscreen",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Fruit Of The Earth, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "63868-244-08",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (63868-244-08) / 237 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "63868-0244-08",
"ProductNDC": "63868-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Cf",
"ProprietaryNameSuffix": "Non Drowsy",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin, Phenylephrine",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140630",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "QUALITY CHOICE (Chain Drug Marketing Association)",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "20; 200; 10",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"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": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140630",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:nasal congestioncough due to minor throat and bronchial irritation."
},
{
"NDCCode": "69081-002-08",
"PackageDescription": "244.94 g in 1 BOTTLE (69081-002-08) ",
"NDC11Code": "69081-0002-08",
"ProductNDC": "69081-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gloves In A Bottle With Spf15",
"NonProprietaryName": "Octinoxate, Octisalate, Homosalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140707",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Gloves in a Bottle, Inc",
"SubstanceName": "HOMOSALATE; OCTINOXATE; OCTISALATE",
"StrengthNumber": ".03; .07; .05",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140707",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N"
},
{
"NDCCode": "71884-011-08",
"PackageDescription": "244 mL in 1 BOTTLE (71884-011-08) ",
"NDC11Code": "71884-0011-08",
"ProductNDC": "71884-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "My-shield Hand Sanitizer Gel",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200526",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Enviro Specialty Chemicals Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200526",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help decrease bacteria on the skin - Recommended for repeated use."
},
{
"NDCCode": "71884-031-08",
"PackageDescription": "244 mL in 1 BOTTLE (71884-031-08) ",
"NDC11Code": "71884-0031-08",
"ProductNDC": "71884-031",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Shield",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200825",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Enviro Specialty Chemicals Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200825",
"SamplePackage": "N"
},
{
"NDCCode": "71884-032-08",
"PackageDescription": "244 mL in 1 BOTTLE (71884-032-08) ",
"NDC11Code": "71884-0032-08",
"ProductNDC": "71884-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Shield Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200826",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Enviro Specialty Chemicals Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200826",
"SamplePackage": "N"
},
{
"NDCCode": "71884-033-08",
"PackageDescription": "244 mL in 1 BOTTLE (71884-033-08) ",
"NDC11Code": "71884-0033-08",
"ProductNDC": "71884-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Shield Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200826",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Enviro Specialty Chemicals Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200826",
"SamplePackage": "N"
},
{
"NDCCode": "71919-244-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-244-08) ",
"NDC11Code": "71919-0244-08",
"ProductNDC": "71919-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cuprum Oxydatum Nigrum",
"NonProprietaryName": "Cupric Oxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20101202",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CUPRIC OXIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20101202",
"SamplePackage": "N"
},
{
"NDCCode": "0143-9506-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9506-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9506-01) ",
"NDC11Code": "00143-9506-10",
"ProductNDC": "0143-9506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etomidate",
"NonProprietaryName": "Etomidate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202354",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ETOMIDATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160225",
"SamplePackage": "N",
"IndicationAndUsage": "Etomidate Injection, USP is indicated by intravenous injection for induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (seeCLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS). Intravenous etomidate is also indicated for supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.",
"Description": "Etomidate Injection, USP is a sterile, nonpyrogenic solution. Each milliliter contains etomidate, 2 mg, propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0). It is intended for the induction of general anesthesia by intravenous injection. The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenyethyl)-1H-imidazole-5-carboxylate and has the following structural formula. Molecular Formula: C14H16N2O2 Molecular Weight: 244.3."
},
{
"NDCCode": "0143-9507-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9507-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0143-9507-01) ",
"NDC11Code": "00143-9507-10",
"ProductNDC": "0143-9507",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etomidate",
"NonProprietaryName": "Etomidate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202354",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ETOMIDATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160225",
"SamplePackage": "N",
"IndicationAndUsage": "Etomidate Injection, USP is indicated by intravenous injection for induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (seeCLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS). Intravenous etomidate is also indicated for supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.",
"Description": "Etomidate Injection, USP is a sterile, nonpyrogenic solution. Each milliliter contains etomidate, 2 mg, propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0). It is intended for the induction of general anesthesia by intravenous injection. The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenyethyl)-1H-imidazole-5-carboxylate and has the following structural formula. Molecular Formula: C14H16N2O2 Molecular Weight: 244.3."
},
{
"NDCCode": "0187-0007-14",
"PackageDescription": "4 VIAL, GLASS in 1 CARTON (0187-0007-14) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "00187-0007-14",
"ProductNDC": "0187-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Virazole",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19860101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018859",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "6",
"StrengthUnit": "g/1",
"Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19860101",
"SamplePackage": "N",
"IndicationAndUsage": "VIRAZOLE® (Ribavirin for Inhalation Solution, USP) is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with VIRAZOLE. The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of VIRAZOLE aerosol (3 to 7 days) and should not be treated with the drug. Thus the decision to treat with VIRAZOLE should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection. Use of aerosolized VIRAZOLE in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with this mode of administration and the specific ventilator being used (see WARNINGS and DOSAGE AND ADMINISTRATION). Diagnosis. RSV infection should be documented by a rapid diagnostic method such as demonstration of viral antigen in respiratory tract secretions by immunofluorescence3,4 or ELISA5 before or during the first 24 hours of treatment. Treatment may be initiated while awaiting rapid diagnostic test results. However, treatment should not be continued without documentation of RSV infection. Non-culture antigen detection techniques may have false positive or false negative results. Assessment of the clinical situation, the time of year and other parameters may warrant reevaluation of the laboratory diagnosis.",
"Description": "VIRAZOLE® (Ribavirin for Inhalation Solution, USP) is a brand name for ribavirin, a synthetic nucleoside with antiviral activity. VIRAZOLE for inhalation solution is a sterile, lyophilized powder to be reconstituted for aerosol administration. Each 100 mL glass vial contains 6 grams of ribavirin, and when reconstituted to the recommended volume of 300 mL with Sterile Water for Injection, USP or Sterile Water for Inhalation (no preservatives added), will contain 20 mg of ribavirin per mL, pH approximately 5.5. Aerosolization is to be carried out in a Small Particle Aerosol Generator (SPAG®-2) nebulizer only. Ribavirin is 1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide, with the following structural formula. Ribavirin is a stable, white crystalline compound with a maximum solubility in water of 142 mg/mL at 25°C and with only a slight solubility in ethanol. The empirical formula is C8H12N4O5 and the molecular weight is 244.21."
},
{
"NDCCode": "0615-8251-05",
"PackageDescription": "15 TABLET in 1 BLISTER PACK (0615-8251-05) ",
"NDC11Code": "00615-8251-05",
"ProductNDC": "0615-8251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180716",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073589",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181112",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa is a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and has the following structural formula. C10H14N2O4∙H2O M.W. 244.24. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and has the following structural formula. C9H11NO4 M.W. 197.19. Carbidopa and levodopa tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. In addition, each tablet contains the following inactive ingredients."
},
{
"NDCCode": "0615-8251-28",
"PackageDescription": "28 TABLET in 1 BLISTER PACK (0615-8251-28) ",
"NDC11Code": "00615-8251-28",
"ProductNDC": "0615-8251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180716",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073589",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240328",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa is a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and has the following structural formula. C10H14N2O4∙H2O M.W. 244.24. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and has the following structural formula. C9H11NO4 M.W. 197.19. Carbidopa and levodopa tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. In addition, each tablet contains the following inactive ingredients."
},
{
"NDCCode": "0615-8251-39",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (0615-8251-39) ",
"NDC11Code": "00615-8251-39",
"ProductNDC": "0615-8251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180716",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073589",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181112",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa is a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and has the following structural formula. C10H14N2O4∙H2O M.W. 244.24. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and has the following structural formula. C9H11NO4 M.W. 197.19. Carbidopa and levodopa tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. In addition, each tablet contains the following inactive ingredients."
},
{
"NDCCode": "0904-6238-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-6238-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-6238-61",
"ProductNDC": "0904-6238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110211",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074260",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110211",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake."
},
{
"NDCCode": "16571-657-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16571-657-10) ",
"NDC11Code": "16571-0657-10",
"ProductNDC": "16571-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cevimeline Hydrochloride",
"NonProprietaryName": "Cevimeline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203775",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CEVIMELINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140617",
"SamplePackage": "N",
"IndicationAndUsage": "Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.",
"Description": "Cevimeline is cis-2’-methylspiro {1-azabicyclo [2.2.2] octane-3, 5’ -[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is C10H17NOS.HCl.1/2 H2O, and its structural formula is. Cevimeline has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201 to 203°C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Inactive ingredients include lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate. Empty capsule shell consists of Titanium Dioxide and Gelatin. Ink used in the imprint is Black SW-9049 which contains Shellac, Dehydrated alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Purified Water, Strong Ammonia Solution, Potassium Hydroxide, and Black Iron Oxide."
},
{
"NDCCode": "16714-121-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16714-121-01) ",
"NDC11Code": "16714-0121-01",
"ProductNDC": "16714-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pilocarpine Hydrochloride",
"NonProprietaryName": "Pilocarpine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190813",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212377",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "PILOCARPINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190813",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGEPilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.",
"Description": "DESCRIPTION. Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a white or almost white, crystalline powder or colorless crystals, hygroscopic which is very soluble in water and freely soluble in ethanol (96 percent). Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] monohydrochloride, has a molecular weight of 244.72. Each 5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 5 mg of pilocarpine hydrochloride USP. Inactive ingredients in the tablet are: hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide. Each 7.5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 7.5 mg of pilocarpine hydrochloride USP. Inactive ingredients in the tablet are: FD&C blue # 2, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16714-244-01",
"PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (16714-244-01) ",
"NDC11Code": "16714-0244-01",
"ProductNDC": "16714-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091020",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210712",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine for oral suspension is indicated in adults for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy., 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias)., 6 reduction of the risk of duodenal ulcer recurrence.",
"Description": "The active ingredient in famotidine for oral suspension is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each 5 mL of famotidine for oral suspension when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: anhydrous citric acid, cherry flavor, confectioner's sugar, microcrystalline cellulose and carboxymethylcellulose sodium, mint flavor, and xanthan gum. Additionally, following inactive ingredients are added as preservatives: methylparaben sodium 0.1%, and sodium benzoate 0.1%. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "16714-927-01",
"PackageDescription": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (16714-927-01) ",
"NDC11Code": "16714-0927-01",
"ProductNDC": "16714-927",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azacitidine",
"NonProprietaryName": "Azacitidine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20190508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201537",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "AZACITIDINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190508",
"SamplePackage": "N",
"Description": "Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244.20. Azacitidine is a white to off- white powder. Azacitidine was found to be soluble in dimethyl sulphoxide, sparingly soluble in water and insoluble in acetone and ethanol. The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder."
},
{
"NDCCode": "33342-244-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-244-07) ",
"NDC11Code": "33342-0244-07",
"ProductNDC": "33342-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207088",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 12.5",
"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": "Active",
"LastUpdate": "2025-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250718",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets USP, provided as a tablet for oral administration, is 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 USP 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-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1 dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains 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: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets)."
},
{
"NDCCode": "33342-244-10",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (33342-244-10) ",
"NDC11Code": "33342-0244-10",
"ProductNDC": "33342-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207088",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 12.5",
"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": "Active",
"LastUpdate": "2025-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250718",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets USP, provided as a tablet for oral administration, is 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 USP 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-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1 dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains 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: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets)."
},
{
"NDCCode": "37000-244-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (37000-244-40) > 118 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "37000-0244-40",
"ProductNDC": "37000-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Olay Complete All Day Uv Moisturizer",
"ProprietaryNameSuffix": "Combination-oily",
"NonProprietaryName": "Octisalate, Avobenzone, Homosalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090701",
"EndMarketingDate": "20140801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "29.4; 29.4; 49; 25.48",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "37000-244-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (37000-244-60) > 177 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "37000-0244-60",
"ProductNDC": "37000-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Olay Complete All Day Uv Moisturizer",
"ProprietaryNameSuffix": "Combination-oily",
"NonProprietaryName": "Octisalate, Avobenzone, Homosalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090701",
"EndMarketingDate": "20140801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "29.4; 29.4; 49; 25.48",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "37835-244-30",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (37835-244-30) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "37835-0244-30",
"ProductNDC": "37835-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gentle Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Bi-Mart",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). this product generally produces bowel movement in 6 to 12 hours."
}
]
}
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<NDCList>
<NDC>
<NDCCode>81996-244-08</NDCCode>
<PackageDescription>228 g in 1 JAR (81996-244-08) </PackageDescription>
<NDC11Code>81996-0244-08</NDC11Code>
<ProductNDC>81996-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nuturna Arthritis Intensive Concentrate For Pain Relief And Recovery</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Nuturna International LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>3.7</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81996-244-02</NDCCode>
<PackageDescription>57 g in 1 JAR (81996-244-02) </PackageDescription>
<NDC11Code>81996-0244-02</NDC11Code>
<ProductNDC>81996-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nuturna Arthritis Intensive Concentrate For Pain Relief And Recovery</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Nuturna International LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>3.7</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81996-244-04</NDCCode>
<PackageDescription>114 g in 1 JAR (81996-244-04) </PackageDescription>
<NDC11Code>81996-0244-04</NDC11Code>
<ProductNDC>81996-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nuturna Arthritis Intensive Concentrate For Pain Relief And Recovery</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Nuturna International LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>3.7</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-244-08</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-244-08) > 3 mL in 1 TUBE (13537-244-07)</PackageDescription>
<NDC11Code>13537-0244-08</NDC11Code>
<ProductNDC>13537-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Natural Finish Moisturizing Foundation Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(claire 4) - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.065; .016</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-244-08</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-244-08) > 3 mL in 1 TUBE (14783-244-07)</PackageDescription>
<NDC11Code>14783-0244-08</NDC11Code>
<ProductNDC>14783-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Natural Finish Moisturizing Foundation Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(claire 4) - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.065; .016</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-244-08</NDCCode>
<PackageDescription>12 VIAL, PLASTIC in 1 CARTON (50580-244-08) > 8 TABLET, COATED in 1 VIAL, PLASTIC</PackageDescription>
<NDC11Code>50580-0244-08</NDC11Code>
<ProductNDC>50580-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Pm</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div McNeil-PPC, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-09-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>62217-244-08</NDCCode>
<PackageDescription>88 g in 1 CAN (62217-244-08) </PackageDescription>
<NDC11Code>62217-0244-08</NDC11Code>
<ProductNDC>62217-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth Sun Town City Mineral Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fruit Of The Earth, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63868-244-08</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (63868-244-08) / 237 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>63868-0244-08</NDC11Code>
<ProductNDC>63868-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Cf</ProprietaryName>
<ProprietaryNameSuffix>Non Drowsy</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Phenylephrine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>QUALITY CHOICE (Chain Drug Marketing Association)</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 200; 10</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:nasal congestioncough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69081-002-08</NDCCode>
<PackageDescription>244.94 g in 1 BOTTLE (69081-002-08) </PackageDescription>
<NDC11Code>69081-0002-08</NDC11Code>
<ProductNDC>69081-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gloves In A Bottle With Spf15</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Homosalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140707</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Gloves in a Bottle, Inc</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>.03; .07; .05</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140707</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71884-011-08</NDCCode>
<PackageDescription>244 mL in 1 BOTTLE (71884-011-08) </PackageDescription>
<NDC11Code>71884-0011-08</NDC11Code>
<ProductNDC>71884-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>My-shield Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Enviro Specialty Chemicals Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help decrease bacteria on the skin - Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71884-031-08</NDCCode>
<PackageDescription>244 mL in 1 BOTTLE (71884-031-08) </PackageDescription>
<NDC11Code>71884-0031-08</NDC11Code>
<ProductNDC>71884-031</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Shield</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200825</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Enviro Specialty Chemicals Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71884-032-08</NDCCode>
<PackageDescription>244 mL in 1 BOTTLE (71884-032-08) </PackageDescription>
<NDC11Code>71884-0032-08</NDC11Code>
<ProductNDC>71884-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Shield Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Enviro Specialty Chemicals Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<PackageDescription>244 mL in 1 BOTTLE (71884-033-08) </PackageDescription>
<NDC11Code>71884-0033-08</NDC11Code>
<ProductNDC>71884-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Shield Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Enviro Specialty Chemicals Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-244-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-244-08) </PackageDescription>
<NDC11Code>71919-0244-08</NDC11Code>
<ProductNDC>71919-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cuprum Oxydatum Nigrum</ProprietaryName>
<NonProprietaryName>Cupric Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CUPRIC OXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0143-9506-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9506-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9506-01) </PackageDescription>
<NDC11Code>00143-9506-10</NDC11Code>
<ProductNDC>0143-9506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etomidate</ProprietaryName>
<NonProprietaryName>Etomidate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202354</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ETOMIDATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Etomidate Injection, USP is indicated by intravenous injection for induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (seeCLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS). Intravenous etomidate is also indicated for supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.</IndicationAndUsage>
<Description>Etomidate Injection, USP is a sterile, nonpyrogenic solution. Each milliliter contains etomidate, 2 mg, propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0). It is intended for the induction of general anesthesia by intravenous injection. The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenyethyl)-1H-imidazole-5-carboxylate and has the following structural formula. Molecular Formula: C14H16N2O2 Molecular Weight: 244.3.</Description>
</NDC>
<NDC>
<NDCCode>0143-9507-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9507-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0143-9507-01) </PackageDescription>
<NDC11Code>00143-9507-10</NDC11Code>
<ProductNDC>0143-9507</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etomidate</ProprietaryName>
<NonProprietaryName>Etomidate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202354</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ETOMIDATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Etomidate Injection, USP is indicated by intravenous injection for induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (seeCLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS). Intravenous etomidate is also indicated for supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.</IndicationAndUsage>
<Description>Etomidate Injection, USP is a sterile, nonpyrogenic solution. Each milliliter contains etomidate, 2 mg, propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0). It is intended for the induction of general anesthesia by intravenous injection. The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenyethyl)-1H-imidazole-5-carboxylate and has the following structural formula. Molecular Formula: C14H16N2O2 Molecular Weight: 244.3.</Description>
</NDC>
<NDC>
<NDCCode>0187-0007-14</NDCCode>
<PackageDescription>4 VIAL, GLASS in 1 CARTON (0187-0007-14) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00187-0007-14</NDC11Code>
<ProductNDC>0187-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Virazole</ProprietaryName>
<NonProprietaryName>Ribavirin</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19860101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018859</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>RIBAVIRIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIRAZOLE® (Ribavirin for Inhalation Solution, USP) is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with VIRAZOLE. The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of VIRAZOLE aerosol (3 to 7 days) and should not be treated with the drug. Thus the decision to treat with VIRAZOLE should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection. Use of aerosolized VIRAZOLE in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with this mode of administration and the specific ventilator being used (see WARNINGS and DOSAGE AND ADMINISTRATION). Diagnosis. RSV infection should be documented by a rapid diagnostic method such as demonstration of viral antigen in respiratory tract secretions by immunofluorescence3,4 or ELISA5 before or during the first 24 hours of treatment. Treatment may be initiated while awaiting rapid diagnostic test results. However, treatment should not be continued without documentation of RSV infection. Non-culture antigen detection techniques may have false positive or false negative results. Assessment of the clinical situation, the time of year and other parameters may warrant reevaluation of the laboratory diagnosis.</IndicationAndUsage>
<Description>VIRAZOLE® (Ribavirin for Inhalation Solution, USP) is a brand name for ribavirin, a synthetic nucleoside with antiviral activity. VIRAZOLE for inhalation solution is a sterile, lyophilized powder to be reconstituted for aerosol administration. Each 100 mL glass vial contains 6 grams of ribavirin, and when reconstituted to the recommended volume of 300 mL with Sterile Water for Injection, USP or Sterile Water for Inhalation (no preservatives added), will contain 20 mg of ribavirin per mL, pH approximately 5.5. Aerosolization is to be carried out in a Small Particle Aerosol Generator (SPAG®-2) nebulizer only. Ribavirin is 1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide, with the following structural formula. Ribavirin is a stable, white crystalline compound with a maximum solubility in water of 142 mg/mL at 25°C and with only a slight solubility in ethanol. The empirical formula is C8H12N4O5 and the molecular weight is 244.21.</Description>
</NDC>
<NDC>
<NDCCode>0615-8251-05</NDCCode>
<PackageDescription>15 TABLET in 1 BLISTER PACK (0615-8251-05) </PackageDescription>
<NDC11Code>00615-8251-05</NDC11Code>
<ProductNDC>0615-8251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180716</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073589</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181112</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa is a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and has the following structural formula. C10H14N2O4∙H2O M.W. 244.24. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and has the following structural formula. C9H11NO4 M.W. 197.19. Carbidopa and levodopa tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. In addition, each tablet contains the following inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0615-8251-28</NDCCode>
<PackageDescription>28 TABLET in 1 BLISTER PACK (0615-8251-28) </PackageDescription>
<NDC11Code>00615-8251-28</NDC11Code>
<ProductNDC>0615-8251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180716</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073589</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240328</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa is a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and has the following structural formula. C10H14N2O4∙H2O M.W. 244.24. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and has the following structural formula. C9H11NO4 M.W. 197.19. Carbidopa and levodopa tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. In addition, each tablet contains the following inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0615-8251-39</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (0615-8251-39) </PackageDescription>
<NDC11Code>00615-8251-39</NDC11Code>
<ProductNDC>0615-8251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180716</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073589</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181112</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa is a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and has the following structural formula. C10H14N2O4∙H2O M.W. 244.24. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and has the following structural formula. C9H11NO4 M.W. 197.19. Carbidopa and levodopa tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. In addition, each tablet contains the following inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0904-6238-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-6238-61) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-6238-61</NDC11Code>
<ProductNDC>0904-6238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110211</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074260</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110211</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths. 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>16571-657-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16571-657-10) </PackageDescription>
<NDC11Code>16571-0657-10</NDC11Code>
<ProductNDC>16571-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cevimeline Hydrochloride</ProprietaryName>
<NonProprietaryName>Cevimeline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203775</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CEVIMELINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.</IndicationAndUsage>
<Description>Cevimeline is cis-2’-methylspiro {1-azabicyclo [2.2.2] octane-3, 5’ -[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is C10H17NOS.HCl.1/2 H2O, and its structural formula is. Cevimeline has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201 to 203°C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Inactive ingredients include lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate. Empty capsule shell consists of Titanium Dioxide and Gelatin. Ink used in the imprint is Black SW-9049 which contains Shellac, Dehydrated alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Purified Water, Strong Ammonia Solution, Potassium Hydroxide, and Black Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>16714-121-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16714-121-01) </PackageDescription>
<NDC11Code>16714-0121-01</NDC11Code>
<ProductNDC>16714-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pilocarpine Hydrochloride</ProprietaryName>
<NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190813</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212377</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190813</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGEPilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.</IndicationAndUsage>
<Description>DESCRIPTION. Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a white or almost white, crystalline powder or colorless crystals, hygroscopic which is very soluble in water and freely soluble in ethanol (96 percent). Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] monohydrochloride, has a molecular weight of 244.72. Each 5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 5 mg of pilocarpine hydrochloride USP. Inactive ingredients in the tablet are: hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide. Each 7.5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 7.5 mg of pilocarpine hydrochloride USP. Inactive ingredients in the tablet are: FD&C blue # 2, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16714-244-01</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, PLASTIC (16714-244-01) </PackageDescription>
<NDC11Code>16714-0244-01</NDC11Code>
<ProductNDC>16714-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091020</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine for oral suspension is indicated in adults for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy., 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias)., 6 reduction of the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>The active ingredient in famotidine for oral suspension is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each 5 mL of famotidine for oral suspension when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: anhydrous citric acid, cherry flavor, confectioner's sugar, microcrystalline cellulose and carboxymethylcellulose sodium, mint flavor, and xanthan gum. Additionally, following inactive ingredients are added as preservatives: methylparaben sodium 0.1%, and sodium benzoate 0.1%. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>16714-927-01</NDCCode>
<PackageDescription>1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (16714-927-01) </PackageDescription>
<NDC11Code>16714-0927-01</NDC11Code>
<ProductNDC>16714-927</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azacitidine</ProprietaryName>
<NonProprietaryName>Azacitidine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201537</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>AZACITIDINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244.20. Azacitidine is a white to off- white powder. Azacitidine was found to be soluble in dimethyl sulphoxide, sparingly soluble in water and insoluble in acetone and ethanol. The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.</Description>
</NDC>
<NDC>
<NDCCode>33342-244-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-244-07) </PackageDescription>
<NDC11Code>33342-0244-07</NDC11Code>
<ProductNDC>33342-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207088</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets USP, provided as a tablet for oral administration, is 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 USP 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-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1 dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains 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: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>33342-244-10</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (33342-244-10) </PackageDescription>
<NDC11Code>33342-0244-10</NDC11Code>
<ProductNDC>33342-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207088</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets USP, provided as a tablet for oral administration, is 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 USP 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-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1 dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains 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: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>37000-244-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (37000-244-40) > 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>37000-0244-40</NDC11Code>
<ProductNDC>37000-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Olay Complete All Day Uv Moisturizer</ProprietaryName>
<ProprietaryNameSuffix>Combination-oily</ProprietaryNameSuffix>
<NonProprietaryName>Octisalate, Avobenzone, Homosalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<EndMarketingDate>20140801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>29.4; 29.4; 49; 25.48</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>37000-244-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (37000-244-60) > 177 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>37000-0244-60</NDC11Code>
<ProductNDC>37000-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Olay Complete All Day Uv Moisturizer</ProprietaryName>
<ProprietaryNameSuffix>Combination-oily</ProprietaryNameSuffix>
<NonProprietaryName>Octisalate, Avobenzone, Homosalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<EndMarketingDate>20140801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>29.4; 29.4; 49; 25.48</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>37835-244-30</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (37835-244-30) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37835-0244-30</NDC11Code>
<ProductNDC>37835-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gentle Laxative</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Bi-Mart</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation (irregularity). this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
</NDCList>