{
"NDC": [
{
"NDCCode": "82494-000-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-000-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0000-17",
"ProductNDC": "82494-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 00 Amande",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-000-01",
"PackageDescription": "1 mL in 1 BAG (82494-000-01) ",
"NDC11Code": "82494-0000-01",
"ProductNDC": "82494-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 00 Amande",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-000-40",
"PackageDescription": "1 TUBE in 1 CARTON (82494-000-40) / 40 mL in 1 TUBE",
"NDC11Code": "82494-0000-40",
"ProductNDC": "82494-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 00 Amande",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "59779-000-17",
"PackageDescription": "283 g in 1 BOTTLE, PLASTIC (59779-000-17)",
"NDC11Code": "59779-0000-17",
"ProductNDC": "59779-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Spf 8",
"NonProprietaryName": "Octinoxate, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121211",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "5; 2",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in water."
},
{
"NDCCode": "74168-000-17",
"PackageDescription": "200 mL in 1 BOTTLE, PUMP (74168-000-17) ",
"NDC11Code": "74168-0000-17",
"ProductNDC": "74168-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Gel",
"ProprietaryNameSuffix": "75% Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Yasili Cosmetics Co. Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200408",
"SamplePackage": "N"
},
{
"NDCCode": "78852-000-17",
"PackageDescription": "750 mL in 1 BOTTLE (78852-000-17) ",
"NDC11Code": "78852-0000-17",
"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": "84334-000-03",
"PackageDescription": "473.17 mL in 1 BOTTLE, PUMP (84334-000-03) ",
"NDC11Code": "84334-0000-03",
"ProductNDC": "84334-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relieving Cream",
"NonProprietaryName": "Camphor And Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20041202",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "GOLDEN TIGER DISTRIBUTION L.L.C.",
"SubstanceName": "MENTHOL; CAMPHOR (SYNTHETIC)",
"StrengthNumber": "3; 3",
"StrengthUnit": "mg/100mL; mg/100mL",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041202",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves the minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 sprains, 4 bruises, 5 strains."
},
{
"NDCCode": "82494-001-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-001-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0001-17",
"ProductNDC": "82494-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 10 Coquillage",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-002-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-002-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0002-17",
"ProductNDC": "82494-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 20 Sable",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-003-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-003-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0003-17",
"ProductNDC": "82494-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 30 Ficelle",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-004-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-004-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0004-17",
"ProductNDC": "82494-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 40 Chanvre",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-005-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-005-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0005-17",
"ProductNDC": "82494-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 50 Palomino",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-006-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-006-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0006-17",
"ProductNDC": "82494-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 60 Sienne",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-007-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-007-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0007-17",
"ProductNDC": "82494-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 70 Santal",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "124",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-008-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-008-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0008-17",
"ProductNDC": "82494-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 80 Barenia",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "73",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-009-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-009-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0009-17",
"ProductNDC": "82494-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 90 Alezan",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "73",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun."
},
{
"NDCCode": "82494-010-17",
"PackageDescription": "1 TUBE in 1 CARTON (82494-010-17) / 17 mL in 1 TUBE",
"NDC11Code": "82494-0010-17",
"ProductNDC": "82494-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermes Plein Air-baume De Teint Perfecteur Naturel-enhancing Complexion Balm 85 Tamarin",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220601",
"EndMarketingDate": "20270124",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "73",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220601",
"EndMarketingDatePackage": "20270124",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see ), decreases the risk of skin cancer and early skin ageing caused by the sun. Directions."
},
{
"NDCCode": "0065-0631-36",
"PackageDescription": "3.5 g in 1 TUBE (0065-0631-36) ",
"NDC11Code": "00065-0631-36",
"ProductNDC": "0065-0631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxitrol",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19720117",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050065",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "1; 3.5; 10000",
"StrengthUnit": "mg/g; mg/g; [USP'U]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19720117",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.",
"Description": "MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is. Neomycin B (R1=H, R2=CH2NH2). Neomycin C (R1=CH2NH2, R2=H). The chemical structure for the active ingredient Polymyxin B Sulfate is. The chemical structure for the active ingredient Dexamethasone is. C22H29FO5. MW = 392.47. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of MAXITROL* (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains:. Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: white petrolatum, anhydrous liquid lanolin."
},
{
"NDCCode": "0069-1305-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1305-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1305-01) ",
"NDC11Code": "00069-1305-10",
"ProductNDC": "0069-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retacrit",
"NonProprietaryName": "Epoetin Alfa-epbx",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20180618",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125545",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "EPOETIN",
"StrengthNumber": "2000",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180618",
"SamplePackage": "N",
"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
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"ProprietaryName": "Retacrit",
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"DosageFormName": "INJECTION, SOLUTION",
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"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
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"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
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"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
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"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1307-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1307-01) ",
"NDC11Code": "00069-1307-10",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retacrit",
"NonProprietaryName": "Epoetin Alfa-epbx",
"DosageFormName": "INJECTION, SOLUTION",
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"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
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"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
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"NDC11Code": "00069-1308-10",
"ProductNDC": "0069-1308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retacrit",
"NonProprietaryName": "Epoetin Alfa-epbx",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
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"ApplicationNumber": "BLA125545",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "EPOETIN",
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"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
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"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
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"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 CARTON (0069-1309-04) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1309-01) ",
"NDC11Code": "00069-1309-04",
"ProductNDC": "0069-1309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retacrit",
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"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20180618",
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"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
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"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2025-06-26",
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"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
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"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (0069-1311-10) / 1 mL in 1 VIAL, MULTI-DOSE (0069-1311-01) ",
"NDC11Code": "00069-1311-10",
"ProductNDC": "0069-1311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retacrit",
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"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125545",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "EPOETIN",
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"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20201109",
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"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
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"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "EPOETIN",
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"LastUpdate": "2025-06-26",
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"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
"NDCCode": "0078-0771-01",
"PackageDescription": "3.5 g in 1 TUBE (0078-0771-01) ",
"NDC11Code": "00078-0771-01",
"ProductNDC": "0078-0771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxitrol",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19720117",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050065",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
"StrengthNumber": "3.5; 10000; 1",
"StrengthUnit": "mg/g; [USP'U]/g; mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200825",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.",
"Description": "MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is. Neomycin B (R1=H, R2=CH2NH2). Neomycin C (R1=CH2NH2, R2=H). The chemical structure for the active ingredient Polymyxin B Sulfate is. The chemical structure for the active ingredient dexamethasone is. C22H29FO5. Molecular Weight = 392.47 g/mol. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains: Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: anhydrous liquid lanolin and white petrolatum."
},
{
"NDCCode": "0078-0792-05",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (0078-0792-05) ",
"NDC11Code": "00078-0792-05",
"ProductNDC": "0078-0792",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxitrol",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19641115",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050023",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "1; 3.5; 10000",
"StrengthUnit": "mg/mL; mg/mL; [USP'U]/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221201",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilusinfluenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.",
"Description": "MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is:. Molecular Weight = 392.45 g/mol. C22H29FO5. Established name:dexamethasone. Chemical name:pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. Neomycin B (R 1=H, R 2=CH 2NH 2). Neomycin C (R 1=CH 2NH 2, R 2=H). The structural formula for polymyxin B sulfate is. Each mL of MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: benzalkonium chloride 0.004% (preservative), hydrochloric acid and/or sodium hydroxide (to adjust pH), hypromellose 2910 0.5%, polysorbate 20, purified water, sodium chloride."
},
{
"NDCCode": "0116-4026-11",
"PackageDescription": "10 TRAY in 1 CASE (0116-4026-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05) ",
"NDC11Code": "00116-4026-11",
"ProductNDC": "0116-4026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin Oral Suspension",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062512",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260206",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. C 47H 75NO 17 MW 926.13. Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C Yellow #10, FD&C Red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment."
},
{
"NDCCode": "0116-4026-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0116-4026-16) ",
"NDC11Code": "00116-4026-16",
"ProductNDC": "0116-4026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin Oral Suspension",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062512",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260209",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. C 47H 75NO 17 MW 926.13. Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C Yellow #10, FD&C Red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment."
},
{
"NDCCode": "0116-4026-50",
"PackageDescription": "5 TRAY in 1 CASE (0116-4026-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05) ",
"NDC11Code": "00116-4026-50",
"ProductNDC": "0116-4026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin Oral Suspension",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062512",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260209",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. C 47H 75NO 17 MW 926.13. Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C Yellow #10, FD&C Red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment."
}
]
}
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<NDCList>
<NDC>
<NDCCode>82494-000-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-000-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0000-17</NDC11Code>
<ProductNDC>82494-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 00 Amande</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
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<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-000-01</NDCCode>
<PackageDescription>1 mL in 1 BAG (82494-000-01) </PackageDescription>
<NDC11Code>82494-0000-01</NDC11Code>
<ProductNDC>82494-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-000-40</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-000-40) / 40 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0000-40</NDC11Code>
<ProductNDC>82494-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 00 Amande</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59779-000-17</NDCCode>
<PackageDescription>283 g in 1 BOTTLE, PLASTIC (59779-000-17)</PackageDescription>
<NDC11Code>59779-0000-17</NDC11Code>
<ProductNDC>59779-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Spf 8</ProprietaryName>
<NonProprietaryName>Octinoxate, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>5; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74168-000-17</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE, PUMP (74168-000-17) </PackageDescription>
<NDC11Code>74168-0000-17</NDC11Code>
<ProductNDC>74168-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Gel</ProprietaryName>
<ProprietaryNameSuffix>75% Alcohol</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Yasili Cosmetics Co. Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78852-000-17</NDCCode>
<PackageDescription>750 mL in 1 BOTTLE (78852-000-17) </PackageDescription>
<NDC11Code>78852-0000-17</NDC11Code>
<ProductNDC>78852-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Si Master Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Ningbo Youcheng Trade Developing Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to help decrease bacteria on the skin that may cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84334-000-03</NDCCode>
<PackageDescription>473.17 mL in 1 BOTTLE, PUMP (84334-000-03) </PackageDescription>
<NDC11Code>84334-0000-03</NDC11Code>
<ProductNDC>84334-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relieving Cream</ProprietaryName>
<NonProprietaryName>Camphor And Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20041202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>GOLDEN TIGER DISTRIBUTION L.L.C.</LabelerName>
<SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>3; 3</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves the minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 sprains, 4 bruises, 5 strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-001-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-001-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0001-17</NDC11Code>
<ProductNDC>82494-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 10 Coquillage</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-002-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-002-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0002-17</NDC11Code>
<ProductNDC>82494-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 20 Sable</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-003-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-003-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0003-17</NDC11Code>
<ProductNDC>82494-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 30 Ficelle</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-004-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-004-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0004-17</NDC11Code>
<ProductNDC>82494-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 40 Chanvre</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-005-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-005-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0005-17</NDC11Code>
<ProductNDC>82494-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 50 Palomino</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-006-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-006-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0006-17</NDC11Code>
<ProductNDC>82494-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 60 Sienne</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-007-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-007-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0007-17</NDC11Code>
<ProductNDC>82494-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 70 Santal</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>124</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-008-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-008-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0008-17</NDC11Code>
<ProductNDC>82494-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 80 Barenia</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>73</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-009-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-009-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0009-17</NDC11Code>
<ProductNDC>82494-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air Natural Enhancing Complexion Balm Spf 30 Sunscreen 90 Alezan</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>73</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82494-010-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82494-010-17) / 17 mL in 1 TUBE</PackageDescription>
<NDC11Code>82494-0010-17</NDC11Code>
<ProductNDC>82494-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermes Plein Air-baume De Teint Perfecteur Naturel-enhancing Complexion Balm 85 Tamarin</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220601</StartMarketingDate>
<EndMarketingDate>20270124</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>73</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220601</StartMarketingDatePackage>
<EndMarketingDatePackage>20270124</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see ), decreases the risk of skin cancer and early skin ageing caused by the sun. Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0065-0631-36</NDCCode>
<PackageDescription>3.5 g in 1 TUBE (0065-0631-36) </PackageDescription>
<NDC11Code>00065-0631-36</NDC11Code>
<ProductNDC>0065-0631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maxitrol</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19720117</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050065</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>1; 3.5; 10000</StrengthNumber>
<StrengthUnit>mg/g; mg/g; [USP'U]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19720117</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
<Description>MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is. Neomycin B (R1=H, R2=CH2NH2). Neomycin C (R1=CH2NH2, R2=H). The chemical structure for the active ingredient Polymyxin B Sulfate is. The chemical structure for the active ingredient Dexamethasone is. C22H29FO5. MW = 392.47. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of MAXITROL* (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains:. Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: white petrolatum, anhydrous liquid lanolin.</Description>
</NDC>
<NDC>
<NDCCode>0069-1305-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1305-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1305-01) </PackageDescription>
<NDC11Code>00069-1305-10</NDC11Code>
<ProductNDC>0069-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Retacrit</ProprietaryName>
<NonProprietaryName>Epoetin Alfa-epbx</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180618</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125545</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>EPOETIN</SubstanceName>
<StrengthNumber>2000</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
</NDC>
<NDC>
<NDCCode>0069-1306-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1306-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1306-01) </PackageDescription>
<NDC11Code>00069-1306-10</NDC11Code>
<ProductNDC>0069-1306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Retacrit</ProprietaryName>
<NonProprietaryName>Epoetin Alfa-epbx</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180618</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125545</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>EPOETIN</SubstanceName>
<StrengthNumber>3000</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
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<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
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<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
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<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
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<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
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<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
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<IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
<Description>MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is. Neomycin B (R1=H, R2=CH2NH2). Neomycin C (R1=CH2NH2, R2=H). The chemical structure for the active ingredient Polymyxin B Sulfate is. The chemical structure for the active ingredient dexamethasone is. C22H29FO5. Molecular Weight = 392.47 g/mol. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains: Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: anhydrous liquid lanolin and white petrolatum.</Description>
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<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19641115</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050023</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>1; 3.5; 10000</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; [USP'U]/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
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<LastUpdate>2024-11-01</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilusinfluenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
<Description>MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is:. Molecular Weight = 392.45 g/mol. C22H29FO5. Established name:dexamethasone. Chemical name:pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. Neomycin B (R 1=H, R 2=CH 2NH 2). Neomycin C (R 1=CH 2NH 2, R 2=H). The structural formula for polymyxin B sulfate is. Each mL of MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: benzalkonium chloride 0.004% (preservative), hydrochloric acid and/or sodium hydroxide (to adjust pH), hypromellose 2910 0.5%, polysorbate 20, purified water, sodium chloride.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin Oral Suspension</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062512</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. C 47H 75NO 17 MW 926.13. Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C Yellow #10, FD&C Red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment.</Description>
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<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0116-4026-16) </PackageDescription>
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<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062512</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. C 47H 75NO 17 MW 926.13. Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C Yellow #10, FD&C Red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment.</Description>
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<NDC>
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<PackageDescription>5 TRAY in 1 CASE (0116-4026-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05) </PackageDescription>
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<ProductNDC>0116-4026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin Oral Suspension</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062512</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. C 47H 75NO 17 MW 926.13. Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C Yellow #10, FD&C Red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment.</Description>
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