{
"NDC": [
{
"NDCCode": "45802-144-64",
"PackageDescription": "1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE",
"NDC11Code": "45802-0144-64",
"ProductNDC": "45802-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"NonProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085368",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "1; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100413",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Hydrocortisone Acetate 1% and Pramoxine HCl 1% Cream is a topical preparation containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below."
},
{
"NDCCode": "20276-144-64",
"PackageDescription": "1890 mL in 1 BOTTLE, PLASTIC (20276-144-64) ",
"NDC11Code": "20276-0144-64",
"ProductNDC": "20276-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lucky",
"ProprietaryNameSuffix": "Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Delta Brands, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201104",
"SamplePackage": "N",
"IndicationAndUsage": "for hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "47682-144-64",
"PackageDescription": "24 CELLO PACK in 1 BOX, UNIT-DOSE (47682-144-64) > 1 LOZENGE in 1 CELLO PACK",
"NDC11Code": "47682-0144-64",
"ProductNDC": "47682-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medique Sepasoothe",
"NonProprietaryName": "Hexylresorcinol, Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20110308",
"EndMarketingDate": "20140613",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "HEXYLRESORCINOL; MENTHOL",
"StrengthNumber": "2.4; 4.5",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-06-17"
},
{
"NDCCode": "45802-060-70",
"PackageDescription": "144 PACKET in 1 CARTON (45802-060-70) / .9 g in 1 PACKET",
"NDC11Code": "45802-0060-70",
"ProductNDC": "45802-060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BACITRACIN",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110620",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent infection in: : 1 minor cuts , 2 scrapes , 3 burns."
},
{
"NDCCode": "45802-061-70",
"PackageDescription": "144 PACKET in 1 CARTON (45802-061-70) > .9 g in 1 PACKET",
"NDC11Code": "45802-0061-70",
"ProductNDC": "45802-061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin, Neomycin, Polymyxin B",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110307",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2019-02-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "45802-143-70",
"PackageDescription": "144 PACKET in 1 CARTON (45802-143-70) / .9 g in 1 PACKET (45802-143-00) ",
"NDC11Code": "45802-0143-70",
"ProductNDC": "45802-143",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin, Polymyxin B",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140520",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2024-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140520",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "45802-438-70",
"PackageDescription": "144 PACKET in 1 CARTON (45802-438-70) > .9 g in 1 PACKET",
"NDC11Code": "45802-0438-70",
"ProductNDC": "45802-438",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110901",
"SamplePackage": "N"
},
{
"NDCCode": "45802-040-64",
"PackageDescription": "118 mL in 1 BOTTLE (45802-040-64) ",
"NDC11Code": "45802-0040-64",
"ProductNDC": "45802-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selenium Sulfide",
"NonProprietaryName": "Selenium Sulfide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089996",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SELENIUM SULFIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060925",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.",
"Description": "A liquid antiseborrheic, antifungal preparation for topical application. Selenium sulfide has the molecular formula SeS2 and has a molecular weight of 143.09."
},
{
"NDCCode": "45802-124-64",
"PackageDescription": "1 TUBE in 1 CARTON (45802-124-64) / 28.4 g in 1 TUBE",
"NDC11Code": "45802-0124-64",
"ProductNDC": "45802-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"NonProprietaryName": "Hydrocortisone Acetate, Pramoxine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "2.5; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170329",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below."
},
{
"NDCCode": "45802-346-64",
"PackageDescription": "1 KIT in 1 CARTON (45802-346-64) * 1 TUBE in 1 CARTON (45802-041-64) > 28.35 g in 1 TUBE * 6 g in 1 POUCH (45802-474-01)",
"NDC11Code": "45802-0346-64",
"ProductNDC": "45802-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"NonProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20100915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "45802-465-64",
"PackageDescription": "120 mL in 1 BOTTLE (45802-465-64) ",
"NDC11Code": "45802-0465-64",
"ProductNDC": "45802-465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoconazole",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO, SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076419",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100119",
"SamplePackage": "N",
"IndicationAndUsage": "Ketoconazole Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare). Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.",
"Description": "Ketoconazole Shampoo, 2% is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty acid diethanolamide, disodium laureth sulfosuccinate, FD & C Red No. 40, hydrochloric acid, imidurea, laurdimonium hydroxypropyl hydrolyzed collagen, PEG-120 methyl glucose dioleate, purified water, sodium chloride, sodium hydroxide, and sodium lauryl ether sulfate. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]piperazine and has the following structural formula."
},
{
"NDCCode": "45802-472-64",
"PackageDescription": "1 TUBE in 1 CARTON (45802-472-64) / 28.35 g in 1 TUBE",
"NDC11Code": "45802-0472-64",
"ProductNDC": "45802-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"NonProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960927",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "2.5; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100413",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below. hydrocortisone acetate. Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11. 17-dihydroxy-, (11-beta)-. C23H32O6; mol. wt: 404.50. pramoxine hydrochloride. 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride. C17H27NO3.HCl; mol. wt: 329.87."
},
{
"NDCCode": "45802-930-64",
"PackageDescription": "1 TUBE in 1 CARTON (45802-930-64) > 28.4 g in 1 TUBE",
"NDC11Code": "45802-0930-64",
"ProductNDC": "45802-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Iodoquinol",
"NonProprietaryName": "Hydrocortisone, Iodoquinol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080714",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "HYDROCORTISONE; IODOQUINOL",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080714",
"SamplePackage": "N"
},
{
"NDCCode": "45802-975-64",
"PackageDescription": "1 TUBE in 1 CARTON (45802-975-64) > 28.35 g in 1 TUBE",
"NDC11Code": "45802-0975-64",
"ProductNDC": "45802-975",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Hydroquinone",
"ProprietaryNameSuffix": "With Sunscreens",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081023",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "HYDROQUINONE; DIOXYBENZONE; OXYBENZONE; PADIMATE O",
"StrengthNumber": "40; 30; 20; 80",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-980-64",
"PackageDescription": "1 TUBE in 1 CARTON (45802-980-64) > 28.35 g in 1 TUBE",
"NDC11Code": "45802-0980-64",
"ProductNDC": "45802-980",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroquinone",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080617",
"EndMarketingDate": "20181121",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "HYDROQUINONE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "45802-982-64",
"PackageDescription": "1 TUBE in 1 CARTON (45802-982-64) > 28.35 g in 1 TUBE",
"NDC11Code": "45802-0982-64",
"ProductNDC": "45802-982",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Hydroquinone",
"ProprietaryNameSuffix": "With Sunscreens",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090204",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "HYDROQUINONE; DIOXYBENZONE; PADIMATE O",
"StrengthNumber": "40; 30; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-984-64",
"PackageDescription": "1 JAR in 1 CARTON (45802-984-64) > 28.4 g in 1 JAR",
"NDC11Code": "45802-0984-64",
"ProductNDC": "45802-984",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Hydroquinone",
"ProprietaryNameSuffix": "With Sunscreens",
"NonProprietaryName": "Hydroquinone, Octinoxate, Oxybenzone, Padimate O",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080923",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "HYDROQUINONE; OCTINOXATE; OXYBENZONE; PADIMATE O",
"StrengthNumber": "40; 40; 40; 80",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-021-46",
"PackageDescription": "56.2 g in 1 BOTTLE, PLASTIC (45802-021-46) ",
"NDC11Code": "45802-0021-46",
"ProductNDC": "45802-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072538",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060630",
"SamplePackage": "N",
"IndicationAndUsage": "Betamethasone Dipropionate Lotion USP, 0.05% is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.",
"Description": "Betamethasone Dipropionate Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water. Sodium hydroxide is used to adjust pH."
},
{
"NDCCode": "45802-505-14",
"PackageDescription": "1 TUBE in 1 CARTON (45802-505-14) / 15 g in 1 TUBE",
"NDC11Code": "45802-0505-14",
"ProductNDC": "45802-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215847",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220520",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is. Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "45802-505-84",
"PackageDescription": "1 TUBE in 1 CARTON (45802-505-84) / 45 g in 1 TUBE",
"NDC11Code": "45802-0505-84",
"ProductNDC": "45802-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215847",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220520",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is. Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "45802-608-01",
"PackageDescription": "1 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBE",
"NDC11Code": "45802-0608-01",
"ProductNDC": "45802-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120308",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022087",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": "3",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120308",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitriol Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older (1.1)Limitations of UseThe safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. (1.2).",
"Description": "Calcitriol Ointment, 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9, 10-secocholesta-5,7,10(19)-triene-1α, 3β,25-triol. The structural formula is. Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C27H44O3, and the molecular weight is 416.64. Calcitriol Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum."
},
{
"NDCCode": "0006-5084-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) ",
"NDC11Code": "00006-5084-01",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "0006-5084-59",
"PackageDescription": "1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) ",
"NDC11Code": "00006-5084-59",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "Y",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "0052-0313-01",
"PackageDescription": "1 KIT in 1 CARTON (0052-0313-01) / 1 CARTRIDGE in 1 KIT / .42 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0313-01",
"ProductNDC": "0052-0313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "350",
"StrengthUnit": "[iU]/.42mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0052-0313-81",
"PackageDescription": "1 KIT in 1 CARTON (0052-0313-81) / 1 CARTRIDGE in 1 KIT / .42 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0313-81",
"ProductNDC": "0052-0313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "350",
"StrengthUnit": "[iU]/.42mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0052-0316-01",
"PackageDescription": "1 KIT in 1 CARTON (0052-0316-01) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0316-01",
"ProductNDC": "0052-0316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "650",
"StrengthUnit": "[iU]/.78mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0052-0316-81",
"PackageDescription": "1 KIT in 1 CARTON (0052-0316-81) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0316-81",
"ProductNDC": "0052-0316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "650",
"StrengthUnit": "[iU]/.78mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0052-0326-01",
"PackageDescription": "1 KIT in 1 CARTON (0052-0326-01) / 1 CARTRIDGE in 1 KIT / 1.17 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0326-01",
"ProductNDC": "0052-0326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "975",
"StrengthUnit": "[iU]/1.17mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "78206-129-01",
"PackageDescription": "1 KIT in 1 CARTON (78206-129-01) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-99) ",
"NDC11Code": "78206-0129-01",
"ProductNDC": "78206-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Organon LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "300",
"StrengthUnit": "[iU]/.36mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2026-05-28",
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"StartMarketingDatePackage": "20230724",
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"IndicationAndUsage": "FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "SUBCUTANEOUS",
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"MarketingCategoryName": "BLA",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta."
}
]
}
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<ProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</ProprietaryName>
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<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
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<EndMarketingDate>20140613</EndMarketingDate>
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<ApplicationNumber>part356</ApplicationNumber>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-06-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-060-70</NDCCode>
<PackageDescription>144 PACKET in 1 CARTON (45802-060-70) / .9 g in 1 PACKET</PackageDescription>
<NDC11Code>45802-0060-70</NDC11Code>
<ProductNDC>45802-060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitracin</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BACITRACIN</SubstanceName>
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<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Synthesis & Repair [PE]</Pharm_Classes>
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<LastUpdate>2024-08-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection in: : 1 minor cuts , 2 scrapes , 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-061-70</NDCCode>
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<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45802-143-70</NDCCode>
<PackageDescription>144 PACKET in 1 CARTON (45802-143-70) / .9 g in 1 PACKET (45802-143-00) </PackageDescription>
<NDC11Code>45802-0143-70</NDC11Code>
<ProductNDC>45802-143</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Neomycin, Polymyxin B</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140520</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
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<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-438-70</NDCCode>
<PackageDescription>144 PACKET in 1 CARTON (45802-438-70) > .9 g in 1 PACKET</PackageDescription>
<NDC11Code>45802-0438-70</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
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<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45802-040-64</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (45802-040-64) </PackageDescription>
<NDC11Code>45802-0040-64</NDC11Code>
<ProductNDC>45802-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selenium Sulfide</ProprietaryName>
<NonProprietaryName>Selenium Sulfide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089996</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SELENIUM SULFIDE</SubstanceName>
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<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.</IndicationAndUsage>
<Description>A liquid antiseborrheic, antifungal preparation for topical application. Selenium sulfide has the molecular formula SeS2 and has a molecular weight of 143.09.</Description>
</NDC>
<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (45802-124-64) / 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0124-64</NDC11Code>
<ProductNDC>45802-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate, Pramoxine Hcl</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>g/100g; g/100g</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below.</Description>
</NDC>
<NDC>
<NDCCode>45802-346-64</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (45802-346-64) * 1 TUBE in 1 CARTON (45802-041-64) > 28.35 g in 1 TUBE * 6 g in 1 POUCH (45802-474-01)</PackageDescription>
<NDC11Code>45802-0346-64</NDC11Code>
<ProductNDC>45802-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-465-64</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (45802-465-64) </PackageDescription>
<NDC11Code>45802-0465-64</NDC11Code>
<ProductNDC>45802-465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoconazole</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO, SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076419</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketoconazole Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare). Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.</IndicationAndUsage>
<Description>Ketoconazole Shampoo, 2% is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty acid diethanolamide, disodium laureth sulfosuccinate, FD & C Red No. 40, hydrochloric acid, imidurea, laurdimonium hydroxypropyl hydrolyzed collagen, PEG-120 methyl glucose dioleate, purified water, sodium chloride, sodium hydroxide, and sodium lauryl ether sulfate. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]piperazine and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>45802-472-64</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-472-64) / 28.35 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0472-64</NDC11Code>
<ProductNDC>45802-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960927</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below. hydrocortisone acetate. Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11. 17-dihydroxy-, (11-beta)-. C23H32O6; mol. wt: 404.50. pramoxine hydrochloride. 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride. C17H27NO3.HCl; mol. wt: 329.87.</Description>
</NDC>
<NDC>
<NDCCode>45802-930-64</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-930-64) > 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0930-64</NDC11Code>
<ProductNDC>45802-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Iodoquinol</ProprietaryName>
<NonProprietaryName>Hydrocortisone, Iodoquinol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080714</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>HYDROCORTISONE; IODOQUINOL</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45802-975-64</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-975-64) > 28.35 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0975-64</NDC11Code>
<ProductNDC>45802-975</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Hydroquinone</ProprietaryName>
<ProprietaryNameSuffix>With Sunscreens</ProprietaryNameSuffix>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081023</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>HYDROQUINONE; DIOXYBENZONE; OXYBENZONE; PADIMATE O</SubstanceName>
<StrengthNumber>40; 30; 20; 80</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-980-64</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-980-64) > 28.35 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0980-64</NDC11Code>
<ProductNDC>45802-980</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroquinone</ProprietaryName>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080617</StartMarketingDate>
<EndMarketingDate>20181121</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>HYDROQUINONE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>45802-982-64</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-982-64) > 28.35 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0982-64</NDC11Code>
<ProductNDC>45802-982</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Hydroquinone</ProprietaryName>
<ProprietaryNameSuffix>With Sunscreens</ProprietaryNameSuffix>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>HYDROQUINONE; DIOXYBENZONE; PADIMATE O</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-984-64</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (45802-984-64) > 28.4 g in 1 JAR</PackageDescription>
<NDC11Code>45802-0984-64</NDC11Code>
<ProductNDC>45802-984</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Hydroquinone</ProprietaryName>
<ProprietaryNameSuffix>With Sunscreens</ProprietaryNameSuffix>
<NonProprietaryName>Hydroquinone, Octinoxate, Oxybenzone, Padimate O</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080923</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>HYDROQUINONE; OCTINOXATE; OXYBENZONE; PADIMATE O</SubstanceName>
<StrengthNumber>40; 40; 40; 80</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-021-46</NDCCode>
<PackageDescription>56.2 g in 1 BOTTLE, PLASTIC (45802-021-46) </PackageDescription>
<NDC11Code>45802-0021-46</NDC11Code>
<ProductNDC>45802-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072538</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betamethasone Dipropionate Lotion USP, 0.05% is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.</IndicationAndUsage>
<Description>Betamethasone Dipropionate Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water. Sodium hydroxide is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>45802-505-14</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-505-14) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0505-14</NDC11Code>
<ProductNDC>45802-505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215847</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is. Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-505-84</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-505-84) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0505-84</NDC11Code>
<ProductNDC>45802-505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215847</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is. Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-608-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0608-01</NDC11Code>
<ProductNDC>45802-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120308</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022087</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitriol Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older (1.1)Limitations of UseThe safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. (1.2).</IndicationAndUsage>
<Description>Calcitriol Ointment, 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9, 10-secocholesta-5,7,10(19)-triene-1α, 3β,25-triol. The structural formula is. Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C27H44O3, and the molecular weight is 416.64. Calcitriol Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0006-5084-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) </PackageDescription>
<NDC11Code>00006-5084-01</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>0006-5084-59</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) </PackageDescription>
<NDC11Code>00006-5084-59</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>0052-0313-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0313-01) / 1 CARTRIDGE in 1 KIT / .42 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0313-01</NDC11Code>
<ProductNDC>0052-0313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>[iU]/.42mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0052-0313-81</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0313-81) / 1 CARTRIDGE in 1 KIT / .42 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0313-81</NDC11Code>
<ProductNDC>0052-0313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>[iU]/.42mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0052-0316-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0316-01) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0316-01</NDC11Code>
<ProductNDC>0052-0316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>[iU]/.78mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0052-0316-81</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0316-81) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0316-81</NDC11Code>
<ProductNDC>0052-0316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>[iU]/.78mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0052-0326-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0326-01) / 1 CARTRIDGE in 1 KIT / 1.17 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0326-01</NDC11Code>
<ProductNDC>0052-0326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>975</StrengthNumber>
<StrengthUnit>[iU]/1.17mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>78206-129-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (78206-129-01) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-99) </PackageDescription>
<NDC11Code>78206-0129-01</NDC11Code>
<ProductNDC>78206-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>[iU]/.36mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>78206-129-59</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (78206-129-59) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58) </PackageDescription>
<NDC11Code>78206-0129-59</NDC11Code>
<ProductNDC>78206-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>[iU]/.36mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
</NDCList>