{
"NDC": [
{
"NDCCode": "75983-000-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-000-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0000-28",
"ProductNDC": "75983-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Antibiotic Bacitraycin Plus",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130630",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "BACITRACIN",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161006",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage."
},
{
"NDCCode": "54705-000-21",
"PackageDescription": "28 mL in 1 BOTTLE, SPRAY (54705-000-21)",
"NDC11Code": "54705-0000-21",
"ProductNDC": "54705-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Air-vita Allergy",
"NonProprietaryName": "Allium Cepa, Ambrosia Artemisiaefolia, Apis Mellifica, Chamomilla, Eucalyptol, Eucalyptus Globulus, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Natrum Muriaticum, Nux Vomica, Quercus Robur, Silicea, Wyethia Helenioides",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141028",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Flutrends International Corporation",
"SubstanceName": "ONION; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; MATRICARIA RECUTITA; EUCALYPTOL; EUCALYPTUS GLOBULUS LEAF; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; QUERCUS ROBUR TWIG BARK; SILICON DIOXIDE; WYETHIA HELENIOIDES ROOT",
"StrengthNumber": "10; 12; 30; 18; 3; 3; 12; 4; 12; 10; 15; 4; 8; 12",
"StrengthUnit": "[hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves allergy and hay fever symptoms such as: itchy, watery eyes sneezing runny nose nasal congestion sinus pressure or headache post nasal drip itchy ears, throat or nose. Natural multi-symptom relief from indoor and seasonal allergies, pollen, ragweed, hay fever, dust, mold, and pet dander."
},
{
"NDCCode": "72383-000-01",
"PackageDescription": "28 g in 1 TUBE (72383-000-01) ",
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"ProductNDC": "72383-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Conzerol",
"NonProprietaryName": "Thuja Oil",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180530",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Discovery Pharma Sp Z O O",
"SubstanceName": "CEDAR LEAF OIL",
"StrengthNumber": "7",
"StrengthUnit": "[hp_C]/g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180530",
"SamplePackage": "N",
"IndicationAndUsage": "Molluscum Contagiosum lesion relief."
},
{
"NDCCode": "73603-000-00",
"PackageDescription": "1 TUBE in 1 BOX (73603-000-00) / 28 g in 1 TUBE",
"NDC11Code": "73603-0000-00",
"ProductNDC": "73603-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Comforte Menstrual Cramp Relief Cream",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230201",
"EndMarketingDate": "20281030",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PMS4PMS LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230201",
"EndMarketingDatePackage": "20281030",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor pain associated with cramps."
},
{
"NDCCode": "78852-000-28",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (78852-000-28) ",
"NDC11Code": "78852-0000-28",
"ProductNDC": "78852-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Si Master Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Ningbo Youcheng Trade Developing Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200616",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to help decrease bacteria on the skin that may cause disease."
},
{
"NDCCode": "81119-000-15",
"PackageDescription": "15 PATCH in 1 PACKAGE (81119-000-15) > 2.28 mL in 1 PATCH",
"NDC11Code": "81119-0000-15",
"ProductNDC": "81119-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smile Antibacterial Wet Wipes With Vitamins",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "KPD, Limited Liability Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "kill germs and remove dirt."
},
{
"NDCCode": "82480-000-01",
"PackageDescription": "1 CAN in 1 BLISTER PACK (82480-000-01) / 28 g in 1 CAN",
"NDC11Code": "82480-0000-01",
"ProductNDC": "82480-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menthol Davis Analgesic",
"NonProprietaryName": "Menthol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230904",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Genia Care Phamaceutical S.A.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20230904",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints."
},
{
"NDCCode": "82710-000-01",
"PackageDescription": "28 g in 1 BOTTLE, GLASS (82710-000-01) ",
"NDC11Code": "82710-0000-01",
"ProductNDC": "82710-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kathari Sun Shield Drops Natural Spf 50",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kathari LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "72; 95",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Provides high protection against sunburns."
},
{
"NDCCode": "83853-000-00",
"PackageDescription": "28 POUCH in 1 CARTON (83853-000-00) / 1 GRANULE, FOR SOLUTION in 1 POUCH",
"NDC11Code": "83853-0000-00",
"ProductNDC": "83853-000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brand Name",
"NonProprietaryName": "N-acetyl-l-leucine",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240118",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "IntraBio Inc",
"SubstanceName": "ACETYLLEUCINE, L-",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240118",
"SamplePackage": "N",
"IndicationAndUsage": "<BRAND NAME> is indicated for the chronic treatment of Niemann-Pick Type C (NPC) in adults and children aged 4 years and older.",
"Description": "<PROPOSED USAN> is a modified amino acid. The chemical name is 2-acetamido-4-methylpentanoic acid. Its molecular formula is C8H15NO3, the molecular mass is 173.21 g/mol, and it has the following chemical structure. Each sachet of <BRAND NAME> granules for oral solution contains 1 g <PROPOSED USAN>. The inactive ingredients are isomalt, hypromellose and strawberry flavor."
},
{
"NDCCode": "87236-000-01",
"PackageDescription": "1 TUBE in 1 CARTON (87236-000-01) / 28.4 g in 1 TUBE",
"NDC11Code": "87236-0000-01",
"ProductNDC": "87236-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "AlderMed Inc.",
"SubstanceName": "BACITRACIN",
"StrengthNumber": "500",
"StrengthUnit": "[iU]/g",
"Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "deep or puncture wounds, animal bites, or serious burns."
},
{
"NDCCode": "75983-001-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-001-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0001-28",
"ProductNDC": "75983-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Antibiotic Bacitracin With Zinc",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170214",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "75983-002-02",
"PackageDescription": "1 TUBE in 1 CARTON (75983-002-02) > 28 g in 1 TUBE (75983-002-01) ",
"NDC11Code": "75983-0002-02",
"ProductNDC": "75983-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Antifungal Medicated",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). proven effective in the prevention of athlete's foot with daily use. for effective relief of itching, burning and cracking."
},
{
"NDCCode": "75983-002-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-002-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0002-28",
"ProductNDC": "75983-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Antifungal Medicated",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180102",
"SamplePackage": "N",
"IndicationAndUsage": "proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). proven effective in the prevention of athlete's foot with daily use. for effective relief of itching, burning and cracking."
},
{
"NDCCode": "75983-003-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-003-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0003-28",
"ProductNDC": "75983-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Original Bacitraycin Plus",
"NonProprietaryName": "Bacitraycin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140305",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "BACITRACIN",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161006",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage."
},
{
"NDCCode": "75983-004-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-004-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0004-28",
"ProductNDC": "75983-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Antibiotic Bacitraycin Plus Maximum Strength",
"NonProprietaryName": "Bacitracin And Pramoxine Hcl",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180220",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "BACITRACIN; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 10",
"StrengthUnit": "[USP'U]/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180220",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "75983-005-02",
"PackageDescription": "1 TUBE in 1 CARTON (75983-005-02) > 28 g in 1 TUBE (75983-005-01) ",
"NDC11Code": "75983-0005-02",
"ProductNDC": "75983-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Bacitraycin Plus Original",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180403",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "BACITRACIN",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180403",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. First Aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "75983-005-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-005-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0005-28",
"ProductNDC": "75983-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Bacitraycin Plus Original",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180403",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "BACITRACIN",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180403",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. First Aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "75983-055-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-055-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0055-28",
"ProductNDC": "75983-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Maximum Strength Bacitraycin Plus",
"NonProprietaryName": "Bacitracin, And Pramoxine Hcl",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp",
"SubstanceName": "BACITRACIN; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 10",
"StrengthUnit": "[USP'U]/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage."
},
{
"NDCCode": "75983-056-01",
"PackageDescription": "1 TUBE in 1 BOX (75983-056-01) > 28 g in 1 TUBE",
"NDC11Code": "75983-0056-01",
"ProductNDC": "75983-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitraycin Plus",
"NonProprietaryName": "Bacitracin Zinc And Pramoxine Hydrochloride",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp",
"SubstanceName": "BACITRACIN ZINC; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 10",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190109",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 adults and children 2 years of age and older:, 2 clean the affected area, 3 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 4 children under 2 years of age: ask a doctor."
},
{
"NDCCode": "75983-056-02",
"PackageDescription": "1 TUBE in 1 BOX (75983-056-02) > 28 g in 1 TUBE",
"NDC11Code": "75983-0056-02",
"ProductNDC": "75983-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitraycin Plus",
"NonProprietaryName": "Bacitracin Zinc And Pramoxine Hydrochloride",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp",
"SubstanceName": "BACITRACIN ZINC; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 10",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190109",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 adults and children 2 years of age and older:, 2 clean the affected area, 3 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 4 children under 2 years of age: ask a doctor."
},
{
"NDCCode": "75983-464-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-464-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0464-28",
"ProductNDC": "75983-464",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Research Antifungal Cream 1oz",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141014",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions: 1 wash affected area and dry thoroughly, 2 apply a thin layer over affected area twice daily (morning and night), 3 supervise children in the use of this product, 4 for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily, 5 for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks, 6 if condition persists longer, ask a doctor, 7 this product is not effective on the scalp or nails."
},
{
"NDCCode": "75983-495-55",
"PackageDescription": "1 TUBE in 1 CARTON (75983-495-55) > 28 g in 1 TUBE",
"NDC11Code": "75983-0495-55",
"ProductNDC": "75983-495",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Macimum Sterngth Bacitraycin Plus",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130630",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp",
"SubstanceName": "BACITRACIN; LIDOCAINE",
"StrengthNumber": "500; 40",
"StrengthUnit": "[USP'U]/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage."
},
{
"NDCCode": "75983-537-28",
"PackageDescription": "1 TUBE in 1 CARTON (75983-537-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0537-28",
"ProductNDC": "75983-537",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Antifungal Medicated Cream 1oz",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141009",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "First Aid Reserach Corp",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions: 1 wash affected area and dry throughly, 2 apply a thin layer over affected area twie daily (morning and night), 3 supervise children in the use of this product, 4 for athlete's foot:pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily, 5 use daily for 4 weeks; if condition persists longer, ask a doctor, 6 to prevent athlete's foot, apply once or twice daily (morning and/or night), 7 this product is not effective on the scalp or nails."
},
{
"NDCCode": "75983-555-28",
"PackageDescription": "1 TUBE in 1 BOX (75983-555-28) > 28 g in 1 TUBE",
"NDC11Code": "75983-0555-28",
"ProductNDC": "75983-555",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Research Bacitraycin Plus Maximum Vertical",
"NonProprietaryName": "Bacitracin Lidocaine",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140306",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "First Aid Research Corp.",
"SubstanceName": "BACITRACIN; LIDOCAINE",
"StrengthNumber": "500; 40",
"StrengthUnit": "[USP'U]/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be convered with a sterile bandage."
},
{
"NDCCode": "0002-5137-11",
"PackageDescription": "1 SYRINGE in 1 CARTON (0002-5137-11) / 3 mL in 1 SYRINGE (0002-5137-01) ",
"NDC11Code": "00002-5137-11",
"ProductNDC": "0002-5137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Onswik",
"ProprietaryNameSuffix": "Kwikpen",
"NonProprietaryName": "Insulin Efsitora Alfa-gobe",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260923",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761408",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN EFSITORA ALFA",
"StrengthNumber": "500",
"StrengthUnit": "[iU]/mL",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260923",
"SamplePackage": "N",
"IndicationAndUsage": "ONSWIK is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Insulin efsitora alfa-gobe is a long-acting insulin analog that is divalent (dimer), consisting of a single-chain insulin (comprised of insulin B-chain analog, a short peptide linker, and an insulin A-chain analog) fused to a second peptide linker that is fused to a human IgG2 Fc region. Each monomer is comprised of 299 amino acid residues. Insulin efsitora alfa-gobe is produced using Chinese Hamster Ovary cells by recombinant DNA technology. The molecule contains 24-Cys residues that are involved in 2 interchain and 10 intrachain disulfide bonds. The predominant post-translational modification includes N-linked glycosylation of the heavy chain (Asn150). The molecular weight of insulin efsitora alfa-gobe is approximately 64 kDa. ONSWIK (insulin efsitora alfa-gobe) injection is a clear and colorless to yellow solution for subcutaneous use. ONSWIK injection is a sterile, preserved formulation supplied in two concentrations (500 units/mL or 1,000 units/mL) manufactured for use in a prefilled pen. Each mL of ONSWIK U-500 contains 500 units of insulin efsitora alfa-gobe and the inactive ingredients benzyl alcohol (9 mg), dibasic sodium phosphate (0.084 mg), glycerin (17 mg), monobasic sodium phosphate (0.53 mg), phenol (1.8 mg), poloxamer 188 (0.4 mg), and Water for Injection. The 500 units/mL cartridge delivers 5 units of ONSWIK per 0.01 mL (14.3 mg/mL). Each mL of ONSWIK U-1,000 contains 1,000 units of insulin efsitora alfa-gobe and the inactive ingredients benzyl alcohol (9 mg), dibasic sodium phosphate (0.168 mg), glycerin (17 mg), monobasic sodium phosphate (1.06 mg), phenol (1.8 mg), poloxamer 188 (0.4 mg), and Water for Injection. The 1,000 units/mL cartridge delivers 10 units of ONSWIK per 0.01 mL (28.6 mg/mL). Hydrochloric acid, glacial acetic acid and/or sodium hydroxide may be added to adjust the pH. ONSWIK has a pH of approximately 6.5."
},
{
"NDCCode": "0002-5240-11",
"PackageDescription": "1 SYRINGE in 1 CARTON (0002-5240-11) / 3 mL in 1 SYRINGE (0002-5240-01) ",
"NDC11Code": "00002-5240-11",
"ProductNDC": "0002-5240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Onswik",
"ProprietaryNameSuffix": "Kwikpen",
"NonProprietaryName": "Insulin Efsitora Alfa-gobe",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260923",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761408",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN EFSITORA ALFA",
"StrengthNumber": "1000",
"StrengthUnit": "[iU]/mL",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260923",
"SamplePackage": "N",
"IndicationAndUsage": "ONSWIK is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Insulin efsitora alfa-gobe is a long-acting insulin analog that is divalent (dimer), consisting of a single-chain insulin (comprised of insulin B-chain analog, a short peptide linker, and an insulin A-chain analog) fused to a second peptide linker that is fused to a human IgG2 Fc region. Each monomer is comprised of 299 amino acid residues. Insulin efsitora alfa-gobe is produced using Chinese Hamster Ovary cells by recombinant DNA technology. The molecule contains 24-Cys residues that are involved in 2 interchain and 10 intrachain disulfide bonds. The predominant post-translational modification includes N-linked glycosylation of the heavy chain (Asn150). The molecular weight of insulin efsitora alfa-gobe is approximately 64 kDa. ONSWIK (insulin efsitora alfa-gobe) injection is a clear and colorless to yellow solution for subcutaneous use. ONSWIK injection is a sterile, preserved formulation supplied in two concentrations (500 units/mL or 1,000 units/mL) manufactured for use in a prefilled pen. Each mL of ONSWIK U-500 contains 500 units of insulin efsitora alfa-gobe and the inactive ingredients benzyl alcohol (9 mg), dibasic sodium phosphate (0.084 mg), glycerin (17 mg), monobasic sodium phosphate (0.53 mg), phenol (1.8 mg), poloxamer 188 (0.4 mg), and Water for Injection. The 500 units/mL cartridge delivers 5 units of ONSWIK per 0.01 mL (14.3 mg/mL). Each mL of ONSWIK U-1,000 contains 1,000 units of insulin efsitora alfa-gobe and the inactive ingredients benzyl alcohol (9 mg), dibasic sodium phosphate (0.168 mg), glycerin (17 mg), monobasic sodium phosphate (1.06 mg), phenol (1.8 mg), poloxamer 188 (0.4 mg), and Water for Injection. The 1,000 units/mL cartridge delivers 10 units of ONSWIK per 0.01 mL (28.6 mg/mL). Hydrochloric acid, glacial acetic acid and/or sodium hydroxide may be added to adjust the pH. ONSWIK has a pH of approximately 6.5."
},
{
"NDCCode": "0008-1030-06",
"PackageDescription": "1 CARTON in 1 KIT (0008-1030-06) / 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) / 60 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00008-1030-06",
"ProductNDC": "0008-1030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19990901",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021083",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990901",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1040-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05) ",
"NDC11Code": "00008-1040-05",
"ProductNDC": "0008-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100301",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100301",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1040-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-1040-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00008-1040-10",
"ProductNDC": "0008-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100301",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100301",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1041-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1041-05) ",
"NDC11Code": "00008-1041-05",
"ProductNDC": "0008-1041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20010701",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
}
]
}
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brand Name</ProprietaryName>
<NonProprietaryName>N-acetyl-l-leucine</NonProprietaryName>
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<Status>Deprecated</Status>
<LastUpdate>2024-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ApplicationNumber>part333B</ApplicationNumber>
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<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<PackageDescription>1 TUBE in 1 CARTON (75983-002-02) > 28 g in 1 TUBE (75983-002-01) </PackageDescription>
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<ProductNDC>75983-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Antifungal Medicated</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>First Aid Research Corp.</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). proven effective in the prevention of athlete's foot with daily use. for effective relief of itching, burning and cracking.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (75983-002-28) > 28 g in 1 TUBE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Antifungal Medicated</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>First Aid Research Corp.</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). proven effective in the prevention of athlete's foot with daily use. for effective relief of itching, burning and cracking.</IndicationAndUsage>
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<PackageDescription>1 TUBE in 1 CARTON (75983-003-28) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0003-28</NDC11Code>
<ProductNDC>75983-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Original Bacitraycin Plus</ProprietaryName>
<NonProprietaryName>Bacitraycin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140305</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp.</LabelerName>
<SubstanceName>BACITRACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-004-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (75983-004-28) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0004-28</NDC11Code>
<ProductNDC>75983-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Antibiotic Bacitraycin Plus Maximum Strength</ProprietaryName>
<NonProprietaryName>Bacitracin And Pramoxine Hcl</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180220</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp.</LabelerName>
<SubstanceName>BACITRACIN; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-005-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (75983-005-02) > 28 g in 1 TUBE (75983-005-01) </PackageDescription>
<NDC11Code>75983-0005-02</NDC11Code>
<ProductNDC>75983-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Bacitraycin Plus Original</ProprietaryName>
<NonProprietaryName>Bacitracin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180403</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp.</LabelerName>
<SubstanceName>BACITRACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Synthesis & Repair [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. First Aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-005-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (75983-005-28) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0005-28</NDC11Code>
<ProductNDC>75983-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Bacitraycin Plus Original</ProprietaryName>
<NonProprietaryName>Bacitracin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180403</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp.</LabelerName>
<SubstanceName>BACITRACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. First Aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-055-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (75983-055-28) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0055-28</NDC11Code>
<ProductNDC>75983-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Maximum Strength Bacitraycin Plus</ProprietaryName>
<NonProprietaryName>Bacitracin, And Pramoxine Hcl</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp</LabelerName>
<SubstanceName>BACITRACIN; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-056-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (75983-056-01) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0056-01</NDC11Code>
<ProductNDC>75983-056</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitraycin Plus</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp</LabelerName>
<SubstanceName>BACITRACIN ZINC; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Synthesis & Repair [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 adults and children 2 years of age and older:, 2 clean the affected area, 3 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 4 children under 2 years of age: ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-056-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (75983-056-02) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0056-02</NDC11Code>
<ProductNDC>75983-056</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitraycin Plus</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp</LabelerName>
<SubstanceName>BACITRACIN ZINC; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Synthesis & Repair [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 adults and children 2 years of age and older:, 2 clean the affected area, 3 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 4 children under 2 years of age: ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-464-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (75983-464-28) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0464-28</NDC11Code>
<ProductNDC>75983-464</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Research Antifungal Cream 1oz</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141014</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>First Aid Research Corp.</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 wash affected area and dry thoroughly, 2 apply a thin layer over affected area twice daily (morning and night), 3 supervise children in the use of this product, 4 for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily, 5 for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks, 6 if condition persists longer, ask a doctor, 7 this product is not effective on the scalp or nails.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-495-55</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (75983-495-55) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0495-55</NDC11Code>
<ProductNDC>75983-495</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Macimum Sterngth Bacitraycin Plus</ProprietaryName>
<NonProprietaryName>Bacitracin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp</LabelerName>
<SubstanceName>BACITRACIN; LIDOCAINE</SubstanceName>
<StrengthNumber>500; 40</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-537-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (75983-537-28) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0537-28</NDC11Code>
<ProductNDC>75983-537</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Antifungal Medicated Cream 1oz</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141009</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>First Aid Reserach Corp</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 wash affected area and dry throughly, 2 apply a thin layer over affected area twie daily (morning and night), 3 supervise children in the use of this product, 4 for athlete's foot:pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily, 5 use daily for 4 weeks; if condition persists longer, ask a doctor, 6 to prevent athlete's foot, apply once or twice daily (morning and/or night), 7 this product is not effective on the scalp or nails.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75983-555-28</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (75983-555-28) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>75983-0555-28</NDC11Code>
<ProductNDC>75983-555</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Research Bacitraycin Plus Maximum Vertical</ProprietaryName>
<NonProprietaryName>Bacitracin Lidocaine</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>First Aid Research Corp.</LabelerName>
<SubstanceName>BACITRACIN; LIDOCAINE</SubstanceName>
<StrengthNumber>500; 40</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be convered with a sterile bandage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0002-5137-11</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-5137-11) / 3 mL in 1 SYRINGE (0002-5137-01) </PackageDescription>
<NDC11Code>00002-5137-11</NDC11Code>
<ProductNDC>0002-5137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Onswik</ProprietaryName>
<ProprietaryNameSuffix>Kwikpen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Efsitora Alfa-gobe</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260923</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761408</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN EFSITORA ALFA</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ONSWIK is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Insulin efsitora alfa-gobe is a long-acting insulin analog that is divalent (dimer), consisting of a single-chain insulin (comprised of insulin B-chain analog, a short peptide linker, and an insulin A-chain analog) fused to a second peptide linker that is fused to a human IgG2 Fc region. Each monomer is comprised of 299 amino acid residues. Insulin efsitora alfa-gobe is produced using Chinese Hamster Ovary cells by recombinant DNA technology. The molecule contains 24-Cys residues that are involved in 2 interchain and 10 intrachain disulfide bonds. The predominant post-translational modification includes N-linked glycosylation of the heavy chain (Asn150). The molecular weight of insulin efsitora alfa-gobe is approximately 64 kDa. ONSWIK (insulin efsitora alfa-gobe) injection is a clear and colorless to yellow solution for subcutaneous use. ONSWIK injection is a sterile, preserved formulation supplied in two concentrations (500 units/mL or 1,000 units/mL) manufactured for use in a prefilled pen. Each mL of ONSWIK U-500 contains 500 units of insulin efsitora alfa-gobe and the inactive ingredients benzyl alcohol (9 mg), dibasic sodium phosphate (0.084 mg), glycerin (17 mg), monobasic sodium phosphate (0.53 mg), phenol (1.8 mg), poloxamer 188 (0.4 mg), and Water for Injection. The 500 units/mL cartridge delivers 5 units of ONSWIK per 0.01 mL (14.3 mg/mL). Each mL of ONSWIK U-1,000 contains 1,000 units of insulin efsitora alfa-gobe and the inactive ingredients benzyl alcohol (9 mg), dibasic sodium phosphate (0.168 mg), glycerin (17 mg), monobasic sodium phosphate (1.06 mg), phenol (1.8 mg), poloxamer 188 (0.4 mg), and Water for Injection. The 1,000 units/mL cartridge delivers 10 units of ONSWIK per 0.01 mL (28.6 mg/mL). Hydrochloric acid, glacial acetic acid and/or sodium hydroxide may be added to adjust the pH. ONSWIK has a pH of approximately 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0002-5240-11</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-5240-11) / 3 mL in 1 SYRINGE (0002-5240-01) </PackageDescription>
<NDC11Code>00002-5240-11</NDC11Code>
<ProductNDC>0002-5240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Onswik</ProprietaryName>
<ProprietaryNameSuffix>Kwikpen</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Efsitora Alfa-gobe</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260923</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761408</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN EFSITORA ALFA</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ONSWIK is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Insulin efsitora alfa-gobe is a long-acting insulin analog that is divalent (dimer), consisting of a single-chain insulin (comprised of insulin B-chain analog, a short peptide linker, and an insulin A-chain analog) fused to a second peptide linker that is fused to a human IgG2 Fc region. Each monomer is comprised of 299 amino acid residues. Insulin efsitora alfa-gobe is produced using Chinese Hamster Ovary cells by recombinant DNA technology. The molecule contains 24-Cys residues that are involved in 2 interchain and 10 intrachain disulfide bonds. The predominant post-translational modification includes N-linked glycosylation of the heavy chain (Asn150). The molecular weight of insulin efsitora alfa-gobe is approximately 64 kDa. ONSWIK (insulin efsitora alfa-gobe) injection is a clear and colorless to yellow solution for subcutaneous use. ONSWIK injection is a sterile, preserved formulation supplied in two concentrations (500 units/mL or 1,000 units/mL) manufactured for use in a prefilled pen. Each mL of ONSWIK U-500 contains 500 units of insulin efsitora alfa-gobe and the inactive ingredients benzyl alcohol (9 mg), dibasic sodium phosphate (0.084 mg), glycerin (17 mg), monobasic sodium phosphate (0.53 mg), phenol (1.8 mg), poloxamer 188 (0.4 mg), and Water for Injection. The 500 units/mL cartridge delivers 5 units of ONSWIK per 0.01 mL (14.3 mg/mL). Each mL of ONSWIK U-1,000 contains 1,000 units of insulin efsitora alfa-gobe and the inactive ingredients benzyl alcohol (9 mg), dibasic sodium phosphate (0.168 mg), glycerin (17 mg), monobasic sodium phosphate (1.06 mg), phenol (1.8 mg), poloxamer 188 (0.4 mg), and Water for Injection. The 1,000 units/mL cartridge delivers 10 units of ONSWIK per 0.01 mL (28.6 mg/mL). Hydrochloric acid, glacial acetic acid and/or sodium hydroxide may be added to adjust the pH. ONSWIK has a pH of approximately 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0008-1030-06</NDCCode>
<PackageDescription>1 CARTON in 1 KIT (0008-1030-06) / 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) / 60 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00008-1030-06</NDC11Code>
<ProductNDC>0008-1030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990901</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021083</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990901</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-1040-05</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05) </PackageDescription>
<NDC11Code>00008-1040-05</NDC11Code>
<ProductNDC>0008-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
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<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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