{
"NDC": [
{
"NDCCode": "72133-120-45",
"PackageDescription": "128 g in 1 TUBE (72133-120-45) ",
"NDC11Code": "72133-0120-45",
"ProductNDC": "72133-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Personal Care",
"ProprietaryNameSuffix": "Vitamin E",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180409",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Delta Brands & Products LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "30",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180409",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily protects minor: ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "72133-121-45",
"PackageDescription": "127 g in 1 TUBE (72133-121-45) ",
"NDC11Code": "72133-0121-45",
"ProductNDC": "72133-121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Personal Care",
"ProprietaryNameSuffix": "Cocoa Butter",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180409",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Delta Brands & Products LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "30",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180409",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily protects minor: ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "72133-321-45",
"PackageDescription": "127 g in 1 TUBE (72133-321-45) ",
"NDC11Code": "72133-0321-45",
"ProductNDC": "72133-321",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Love Personal Care",
"ProprietaryNameSuffix": "Diaper Rash",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180409",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Delta Brands & Products LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180409",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps treat and prevent diaper rash. ■ soothes and relieves irritated skin. ■ protects your baby's skin from wetness."
},
{
"NDCCode": "72133-905-01",
"PackageDescription": "45 g in 1 BOTTLE, SPRAY (72133-905-01) ",
"NDC11Code": "72133-0905-01",
"ProductNDC": "72133-905",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Personal Care Quick Dry Antiperspirant",
"NonProprietaryName": "Aluminum Chlorohydrate 20.2%",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Delta Brands & Products, LLC",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "9.05",
"StrengthUnit": "g/45g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180331",
"SamplePackage": "N",
"IndicationAndUsage": "Use reduces underarm wetness."
},
{
"NDCCode": "72133-906-01",
"PackageDescription": "45 g in 1 BOTTLE, SPRAY (72133-906-01) ",
"NDC11Code": "72133-0906-01",
"ProductNDC": "72133-906",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Personal Care Quick Dry Antiperspirant",
"NonProprietaryName": "Aluminum Chlorohydrate 20.2%",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180331",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Delta Brands & Products, LLC",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "9.05",
"StrengthUnit": "g/45g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180331",
"SamplePackage": "N",
"IndicationAndUsage": "Use reduces underarm wetness."
},
{
"NDCCode": "20276-120-45",
"PackageDescription": "127 g in 1 TUBE (20276-120-45) ",
"NDC11Code": "20276-0120-45",
"ProductNDC": "20276-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lucky Super Soft",
"ProprietaryNameSuffix": "Vitamin E",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Delta Brands Inc",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "30",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150301",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "35000-120-45",
"PackageDescription": "127 g in 1 CARTON (35000-120-45)",
"NDC11Code": "35000-0120-45",
"ProductNDC": "35000-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Protex",
"ProprietaryNameSuffix": "Deep Clean",
"NonProprietaryName": "Triclocarban",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130603",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "TRICLOCARBAN",
"StrengthNumber": "4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "43353-120-45",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (43353-120-45) ",
"NDC11Code": "43353-0120-45",
"ProductNDC": "43353-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130128",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020702",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151104",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion."
},
{
"NDCCode": "44781-120-01",
"PackageDescription": "45 mL in 1 CARTON (44781-120-01)",
"NDC11Code": "44781-0120-01",
"ProductNDC": "44781-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wrinkless Plus",
"ProprietaryNameSuffix": "Ct-1 Lifting Up Essence",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "CREAM",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "ZION SYNTHETIC FIBER CO., LTD.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": ".45",
"StrengthUnit": "mL/45mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications and Usage:Tighten the lid after using it.Don't keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.Please apply it an adequate quantity evenly on face, throat, arms and legs at the last stage of basic makeup.Please apply it once again on your skin at the time when you're going out, sports activity, and any activities of outside."
},
{
"NDCCode": "50844-120-45",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (50844-120-45) ",
"NDC11Code": "50844-0120-45",
"ProductNDC": "50844-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220428",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "L.N.K. International, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220428",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms:sore throatnasal congestionfeverheadacheminor aches and painscough due to minor throat and bronchial irritation."
},
{
"NDCCode": "52915-120-45",
"PackageDescription": "133 mL in 1 CONTAINER (52915-120-45) ",
"NDC11Code": "52915-0120-45",
"ProductNDC": "52915-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema",
"NonProprietaryName": "Oatmeal",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "ORGANIC & SUSTAINABLE BEAUTY",
"SubstanceName": "OATMEAL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121201",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects & helps relieve minor skin irritation and itching due to: 1 Rashes, 2 Eczema, 3 Poison ivy, oak, or sumac, 4 Insect bites."
},
{
"NDCCode": "60429-120-45",
"PackageDescription": "450 mL in 1 BOTTLE (60429-120-45)",
"NDC11Code": "60429-0120-45",
"ProductNDC": "60429-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20040920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076729",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68988-120-01",
"PackageDescription": "45 g in 1 CARTON (68988-120-01)",
"NDC11Code": "68988-0120-01",
"ProductNDC": "68988-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Plagentra Soothing Revolution Suncity",
"NonProprietaryName": "Octinoxate, Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "C.A Pharm Co., Ltd.",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "2.25; 2.25",
"StrengthUnit": "g/45g; g/45g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indication and usage:1) Tighten the lid after using it.2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.3) Use it on the day you will be in the sun, 30 minutes before you go outside, apply on ounce of sunscreen."
},
{
"NDCCode": "69452-116-45",
"PackageDescription": "1 BOTTLE in 1 CARTON (69452-116-45) / 120 mL in 1 BOTTLE",
"NDC11Code": "69452-0116-45",
"ProductNDC": "69452-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobazam",
"NonProprietaryName": "Clobazam",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208819",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "CLOBAZAM",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "N",
"IndicationAndUsage": "Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.",
"Description": "Clobazam is a white to almost white crystalline powder with a slightly bitter taste; is practically insoluble in water, sparingly soluble in ethanol and in methanol, freely soluble in dichloromethane and in acetone. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is C 16H 13O 2N 2Cl and the molecular weight is 300.7. Clobazam is available for oral administration as a white to off-white suspension containing clobazam at a concentration of 2.5 mg/mL. Inactive ingredients include artificial mixed berry flavor, citric acid monohydrate, disodium hydrogen phosphate dihydrate, magnesium aluminum silicate, maltitol solution, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, simethicone emulsion, sucralose powder, and xanthan gum."
},
{
"NDCCode": "69842-237-45",
"PackageDescription": "2 BOTTLE in 1 CARTON (69842-237-45) / 120 TABLET in 1 BOTTLE",
"NDC11Code": "69842-0237-45",
"ProductNDC": "69842-237",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride (allergy)",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090760",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190726",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
},
{
"NDCCode": "69842-242-45",
"PackageDescription": "2 BOTTLE in 1 CARTON (69842-242-45) / 120 TABLET in 1 BOTTLE",
"NDC11Code": "69842-0242-45",
"ProductNDC": "69842-242",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208314",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190826",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
},
{
"NDCCode": "71322-120-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (71322-120-02) > 45 g in 1 CONTAINER (71322-120-01)",
"NDC11Code": "71322-0120-02",
"ProductNDC": "71322-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sonatural Pow Der4room Fixing It Full Cover Neutral Beige",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170302",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Sonatural Global Co.,Ltd",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "9.04; 2.83",
"StrengthUnit": "g/45g; g/45g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"Description": "Indications & Usage: In base make up stage, take up adequate amount and smooth evenly to the face from the inside of the face outward. Dosage & Administration: Take up adequate amount and smooth evenly."
},
{
"NDCCode": "71970-303-45",
"PackageDescription": "120 mL in 1 JAR (71970-303-45) ",
"NDC11Code": "71970-0303-45",
"ProductNDC": "71970-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Active Again",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180830",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Hope Science Inc",
"SubstanceName": "MENTHOL",
"StrengthNumber": "1.25",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180830",
"SamplePackage": "N"
},
{
"NDCCode": "72578-120-08",
"PackageDescription": "1 TUBE in 1 CARTON (72578-120-08) / 45 g in 1 TUBE",
"NDC11Code": "72578-0120-08",
"ProductNDC": "72578-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215210",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230610",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.",
"Description": "Ivermectin cream, 1% is a white to pale yellow homogeneous cream. Each gram of ivermectin cream contains 10 mg of ivermectin, USP. It is intended for topical use. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0 % and not more than 102.0 % of 5-O-demethyl-22,23-dihydroavermectin A1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b or H2B1a and H2B1b, respectively; and the ratio (calculated by area percentage) of component H2B1a/(H2B1a + H2B1b)) is not less than 90.0 %. The respective empirical formulas of H2B1a and H2B1b are C48H74O14 and C47H72O14 with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H2B1a: R = C2H5, Component H2B1b: R = CH3. Ivermectin cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, cocodiethanolamide, dimethicone, dimethyl isosorbide, edetate disodium, glycerin, isopropyl palmitate, methyl paraben, propyl paraben, purified water, sodium hydroxide, sodium lauryl sulfate, and stearyl alcohol."
},
{
"NDCCode": "72650-080-01",
"PackageDescription": "1 KIT in 1 BOX (72650-080-01) * 120 mL in 1 BOTTLE, SPRAY * 45 mL in 1 BOTTLE",
"NDC11Code": "72650-0080-01",
"ProductNDC": "72650-080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Incellderm Dermatology First Package",
"NonProprietaryName": "Niacinamide, Adenosine",
"DosageFormName": "KIT",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Riman Co., Ltd.",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200801",
"SamplePackage": "N",
"IndicationAndUsage": "Helps to brighten the skin.Helps to improve wrinkles in the skin."
},
{
"NDCCode": "78898-275-02",
"PackageDescription": "120 PATCH in 1 PACKET (78898-275-02) > 6.45 mL in 1 PATCH",
"NDC11Code": "78898-0275-02",
"ProductNDC": "78898-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ecowipes Antiseptic Hand Sanitizer Wipes",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200312",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Eco Wipes Vietnam Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".75",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "79122-001-45",
"PackageDescription": "120 mL in 1 BOTTLE (79122-001-45) ",
"NDC11Code": "79122-0001-45",
"ProductNDC": "79122-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Biowellness LLC",
"SubstanceName": "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL",
"StrengthNumber": ".25; 70",
"StrengthUnit": "g/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-10-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200625",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79180-001-45",
"PackageDescription": "120 mL in 1 BOTTLE (79180-001-45) ",
"NDC11Code": "79180-0001-45",
"ProductNDC": "79180-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "DEWARS COSMETIQUE LTDA",
"SubstanceName": "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL",
"StrengthNumber": ".25; 70",
"StrengthUnit": "g/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200625",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0069-0227-03",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03) ",
"NDC11Code": "00069-0227-03",
"ProductNDC": "0069-0227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorbrena",
"NonProprietaryName": "Lorlatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210868",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "LORLATINIB",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Cation Transporter 1 Inhibitors [MoA], P-Glycoprotein Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250103",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"IndicationAndUsage": "LORBRENA® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.",
"Description": "LORBRENA (lorlatinib) is a kinase inhibitor for oral administration. The molecular formula is C21H19FN6O2 (anhydrous form) and the molecular weight is 406.41 Daltons. The chemical name is (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-4,8-methenopyrazolo[4,3-h][2,5,11] benzoxadiazacyclotetradecine-3-carbonitrile. The chemical structure is shown below. Lorlatinib is a white to off-white powder with a pKa of 4.92. The solubility of lorlatinib in aqueous media decreases over the range pH 2.55 to pH 8.02 from 32.38 mg/mL to 0.17 mg/mL. The log of the distribution coefficient (octanol/water) at pH 9 is 2.45. LORBRENA is supplied as tablets containing 25 mg or 100 mg of lorlatinib with the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate. The film-coating contains hydroxypropyl methylcellulose (HPMC) 2910/hypromellose, lactose monohydrate, macrogol/polyethylene glycol (PEG) 3350, triacetin, titanium dioxide, ferrosoferric oxide/black iron oxide, and iron oxide red."
},
{
"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)."
},
{
"NDCCode": "0069-1306-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1306-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1306-01) ",
"NDC11Code": "00069-1306-10",
"ProductNDC": "0069-1306",
"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": "3000",
"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)."
},
{
"NDCCode": "0069-1307-10",
"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",
"ProductNDC": "0069-1307",
"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": "4000",
"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)."
},
{
"NDCCode": "0069-1308-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1308-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1308-01) ",
"NDC11Code": "00069-1308-10",
"ProductNDC": "0069-1308",
"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": "10000",
"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)."
},
{
"NDCCode": "0069-1309-04",
"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",
"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": "40000",
"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)."
},
{
"NDCCode": "0069-1311-10",
"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",
"NonProprietaryName": "Epoetin Alfa-epbx",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125545",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "EPOETIN",
"StrengthNumber": "20000",
"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": "20201109",
"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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<NDCList>
<NDC>
<NDCCode>72133-120-45</NDCCode>
<PackageDescription>128 g in 1 TUBE (72133-120-45) </PackageDescription>
<NDC11Code>72133-0120-45</NDC11Code>
<ProductNDC>72133-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Personal Care</ProprietaryName>
<ProprietaryNameSuffix>Vitamin E</ProprietaryNameSuffix>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180409</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Delta Brands & Products LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily protects minor: ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72133-121-45</NDCCode>
<PackageDescription>127 g in 1 TUBE (72133-121-45) </PackageDescription>
<NDC11Code>72133-0121-45</NDC11Code>
<ProductNDC>72133-121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Personal Care</ProprietaryName>
<ProprietaryNameSuffix>Cocoa Butter</ProprietaryNameSuffix>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180409</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Delta Brands & Products LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily protects minor: ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72133-321-45</NDCCode>
<PackageDescription>127 g in 1 TUBE (72133-321-45) </PackageDescription>
<NDC11Code>72133-0321-45</NDC11Code>
<ProductNDC>72133-321</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Love Personal Care</ProprietaryName>
<ProprietaryNameSuffix>Diaper Rash</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180409</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Delta Brands & Products LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ helps treat and prevent diaper rash. ■ soothes and relieves irritated skin. ■ protects your baby's skin from wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72133-905-01</NDCCode>
<PackageDescription>45 g in 1 BOTTLE, SPRAY (72133-905-01) </PackageDescription>
<NDC11Code>72133-0905-01</NDC11Code>
<ProductNDC>72133-905</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Personal Care Quick Dry Antiperspirant</ProprietaryName>
<NonProprietaryName>Aluminum Chlorohydrate 20.2%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Delta Brands & Products, LLC</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>9.05</StrengthNumber>
<StrengthUnit>g/45g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72133-906-01</NDCCode>
<PackageDescription>45 g in 1 BOTTLE, SPRAY (72133-906-01) </PackageDescription>
<NDC11Code>72133-0906-01</NDC11Code>
<ProductNDC>72133-906</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Personal Care Quick Dry Antiperspirant</ProprietaryName>
<NonProprietaryName>Aluminum Chlorohydrate 20.2%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Delta Brands & Products, LLC</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>9.05</StrengthNumber>
<StrengthUnit>g/45g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>20276-120-45</NDCCode>
<PackageDescription>127 g in 1 TUBE (20276-120-45) </PackageDescription>
<NDC11Code>20276-0120-45</NDC11Code>
<ProductNDC>20276-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lucky Super Soft</ProprietaryName>
<ProprietaryNameSuffix>Vitamin E</ProprietaryNameSuffix>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Delta Brands Inc</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-120-45</NDCCode>
<PackageDescription>127 g in 1 CARTON (35000-120-45)</PackageDescription>
<NDC11Code>35000-0120-45</NDC11Code>
<ProductNDC>35000-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Protex</ProprietaryName>
<ProprietaryNameSuffix>Deep Clean</ProprietaryNameSuffix>
<NonProprietaryName>Triclocarban</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130603</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>TRICLOCARBAN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>43353-120-45</NDCCode>
<PackageDescription>45 TABLET, FILM COATED in 1 BOTTLE (43353-120-45) </PackageDescription>
<NDC11Code>43353-0120-45</NDC11Code>
<ProductNDC>43353-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130128</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
</NDC>
<NDC>
<NDCCode>44781-120-01</NDCCode>
<PackageDescription>45 mL in 1 CARTON (44781-120-01)</PackageDescription>
<NDC11Code>44781-0120-01</NDC11Code>
<ProductNDC>44781-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wrinkless Plus</ProprietaryName>
<ProprietaryNameSuffix>Ct-1 Lifting Up Essence</ProprietaryNameSuffix>
<NonProprietaryName>Dimethicone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>ZION SYNTHETIC FIBER CO., LTD.</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>.45</StrengthNumber>
<StrengthUnit>mL/45mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications and Usage:Tighten the lid after using it.Don't keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.Please apply it an adequate quantity evenly on face, throat, arms and legs at the last stage of basic makeup.Please apply it once again on your skin at the time when you're going out, sports activity, and any activities of outside.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50844-120-45</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (50844-120-45) </PackageDescription>
<NDC11Code>50844-0120-45</NDC11Code>
<ProductNDC>50844-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>L.N.K. International, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms:sore throatnasal congestionfeverheadacheminor aches and painscough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52915-120-45</NDCCode>
<PackageDescription>133 mL in 1 CONTAINER (52915-120-45) </PackageDescription>
<NDC11Code>52915-0120-45</NDC11Code>
<ProductNDC>52915-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eczema</ProprietaryName>
<NonProprietaryName>Oatmeal</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ORGANIC & SUSTAINABLE BEAUTY</LabelerName>
<SubstanceName>OATMEAL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects & helps relieve minor skin irritation and itching due to: 1 Rashes, 2 Eczema, 3 Poison ivy, oak, or sumac, 4 Insect bites.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60429-120-45</NDCCode>
<PackageDescription>450 mL in 1 BOTTLE (60429-120-45)</PackageDescription>
<NDC11Code>60429-0120-45</NDC11Code>
<ProductNDC>60429-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076729</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>68988-120-01</NDCCode>
<PackageDescription>45 g in 1 CARTON (68988-120-01)</PackageDescription>
<NDC11Code>68988-0120-01</NDC11Code>
<ProductNDC>68988-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Plagentra Soothing Revolution Suncity</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>C.A Pharm Co., Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>2.25; 2.25</StrengthNumber>
<StrengthUnit>g/45g; g/45g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indication and usage:1) Tighten the lid after using it.2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.3) Use it on the day you will be in the sun, 30 minutes before you go outside, apply on ounce of sunscreen.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69452-116-45</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69452-116-45) / 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69452-0116-45</NDC11Code>
<ProductNDC>69452-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobazam</ProprietaryName>
<NonProprietaryName>Clobazam</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208819</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>CLOBAZAM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.</IndicationAndUsage>
<Description>Clobazam is a white to almost white crystalline powder with a slightly bitter taste; is practically insoluble in water, sparingly soluble in ethanol and in methanol, freely soluble in dichloromethane and in acetone. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is C 16H 13O 2N 2Cl and the molecular weight is 300.7. Clobazam is available for oral administration as a white to off-white suspension containing clobazam at a concentration of 2.5 mg/mL. Inactive ingredients include artificial mixed berry flavor, citric acid monohydrate, disodium hydrogen phosphate dihydrate, magnesium aluminum silicate, maltitol solution, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, simethicone emulsion, sucralose powder, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>69842-237-45</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (69842-237-45) / 120 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0237-45</NDC11Code>
<ProductNDC>69842-237</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090760</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-242-45</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (69842-242-45) / 120 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0242-45</NDC11Code>
<ProductNDC>69842-242</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208314</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71322-120-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (71322-120-02) > 45 g in 1 CONTAINER (71322-120-01)</PackageDescription>
<NDC11Code>71322-0120-02</NDC11Code>
<ProductNDC>71322-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sonatural Pow Der4room Fixing It Full Cover Neutral Beige</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170302</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Sonatural Global Co.,Ltd</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>9.04; 2.83</StrengthNumber>
<StrengthUnit>g/45g; g/45g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<Description>Indications & Usage: In base make up stage, take up adequate amount and smooth evenly to the face from the inside of the face outward. Dosage & Administration: Take up adequate amount and smooth evenly.</Description>
</NDC>
<NDC>
<NDCCode>71970-303-45</NDCCode>
<PackageDescription>120 mL in 1 JAR (71970-303-45) </PackageDescription>
<NDC11Code>71970-0303-45</NDC11Code>
<ProductNDC>71970-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Active Again</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Hope Science Inc</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72578-120-08</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72578-120-08) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>72578-0120-08</NDC11Code>
<ProductNDC>72578-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215210</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>Ivermectin cream, 1% is a white to pale yellow homogeneous cream. Each gram of ivermectin cream contains 10 mg of ivermectin, USP. It is intended for topical use. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin is a mixture containing not less than 95.0 % and not more than 102.0 % of 5-O-demethyl-22,23-dihydroavermectin A1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b or H2B1a and H2B1b, respectively; and the ratio (calculated by area percentage) of component H2B1a/(H2B1a + H2B1b)) is not less than 90.0 %. The respective empirical formulas of H2B1a and H2B1b are C48H74O14 and C47H72O14 with molecular weights of 875.10 and 861.07 respectively. The structural formulas are. Component H2B1a: R = C2H5, Component H2B1b: R = CH3. Ivermectin cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, cocodiethanolamide, dimethicone, dimethyl isosorbide, edetate disodium, glycerin, isopropyl palmitate, methyl paraben, propyl paraben, purified water, sodium hydroxide, sodium lauryl sulfate, and stearyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>72650-080-01</NDCCode>
<PackageDescription>1 KIT in 1 BOX (72650-080-01) * 120 mL in 1 BOTTLE, SPRAY * 45 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72650-0080-01</NDC11Code>
<ProductNDC>72650-080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Incellderm Dermatology First Package</ProprietaryName>
<NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Riman Co., Ltd.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps to brighten the skin.Helps to improve wrinkles in the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78898-275-02</NDCCode>
<PackageDescription>120 PATCH in 1 PACKET (78898-275-02) > 6.45 mL in 1 PATCH</PackageDescription>
<NDC11Code>78898-0275-02</NDC11Code>
<ProductNDC>78898-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ecowipes Antiseptic Hand Sanitizer Wipes</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200312</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Eco Wipes Vietnam Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79122-001-45</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (79122-001-45) </PackageDescription>
<NDC11Code>79122-0001-45</NDC11Code>
<ProductNDC>79122-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Biowellness LLC</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.25; 70</StrengthNumber>
<StrengthUnit>g/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79180-001-45</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (79180-001-45) </PackageDescription>
<NDC11Code>79180-0001-45</NDC11Code>
<ProductNDC>79180-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>DEWARS COSMETIQUE LTDA</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.25; 70</StrengthNumber>
<StrengthUnit>g/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-0227-03</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03) </PackageDescription>
<NDC11Code>00069-0227-03</NDC11Code>
<ProductNDC>0069-0227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorbrena</ProprietaryName>
<NonProprietaryName>Lorlatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210868</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>LORLATINIB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Cation Transporter 1 Inhibitors [MoA], P-Glycoprotein Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250103</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LORBRENA® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.</IndicationAndUsage>
<Description>LORBRENA (lorlatinib) is a kinase inhibitor for oral administration. The molecular formula is C21H19FN6O2 (anhydrous form) and the molecular weight is 406.41 Daltons. The chemical name is (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-4,8-methenopyrazolo[4,3-h][2,5,11] benzoxadiazacyclotetradecine-3-carbonitrile. The chemical structure is shown below. Lorlatinib is a white to off-white powder with a pKa of 4.92. The solubility of lorlatinib in aqueous media decreases over the range pH 2.55 to pH 8.02 from 32.38 mg/mL to 0.17 mg/mL. The log of the distribution coefficient (octanol/water) at pH 9 is 2.45. LORBRENA is supplied as tablets containing 25 mg or 100 mg of lorlatinib with the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate. The film-coating contains hydroxypropyl methylcellulose (HPMC) 2910/hypromellose, lactose monohydrate, macrogol/polyethylene glycol (PEG) 3350, triacetin, titanium dioxide, ferrosoferric oxide/black iron oxide, and iron oxide red.</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>
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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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