{
"NDC": [
{
"NDCCode": "50804-085-17",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (50804-085-17) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "50804-0085-17",
"ProductNDC": "50804-085",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Allergy 24 Hour",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20150619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078104",
"LabelerName": "Geiss, Destin & Dunn Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "55",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: : 1 ■nasal congestion , 2 ■runny nose , 3 ■sneezing, 4 ■itchy nose."
},
{
"NDCCode": "50804-112-17",
"PackageDescription": "150 TABLET, CHEWABLE in 1 BOTTLE (50804-112-17) ",
"NDC11Code": "50804-0112-17",
"ProductNDC": "50804-112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Goodsense Regular Strength Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20231207",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part331",
"LabelerName": "GoodSense",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231207",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "50804-113-17",
"PackageDescription": "150 TABLET, CHEWABLE in 1 BOTTLE (50804-113-17) ",
"NDC11Code": "50804-0113-17",
"ProductNDC": "50804-113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Goodsense Regular Strength Antacid Peppermint",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180808",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "GoodSense",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190320",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "50804-007-01",
"PackageDescription": ".4 mL in 1 POUCH (50804-007-01) ",
"NDC11Code": "50804-0007-01",
"ProductNDC": "50804-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Goodsense Alcohol Swabs",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Geiss, Destin and Dunn",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".07",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2023-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191104",
"SamplePackage": "N",
"IndicationAndUsage": "Wipe injection site vigorously and discard."
},
{
"NDCCode": "50804-311-15",
"PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (50804-311-15) ",
"NDC11Code": "50804-0311-15",
"ProductNDC": "50804-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Everyday Clean",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090609",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Perrigo Direct, Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090609",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "50804-318-13",
"PackageDescription": "1250 mL in 1 BOTTLE, PLASTIC (50804-318-13) ",
"NDC11Code": "50804-0318-13",
"ProductNDC": "50804-318",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic",
"NonProprietaryName": "Eucayptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "19900915",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Perrigo Direct, Inc.",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19900915",
"SamplePackage": "N",
"IndicationAndUsage": "helps control plaque that leads to gingivitis."
},
{
"NDCCode": "50804-318-69",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (50804-318-69) ",
"NDC11Code": "50804-0318-69",
"ProductNDC": "50804-318",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic",
"NonProprietaryName": "Eucayptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "19900915",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Perrigo Direct, Inc.",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19900915",
"SamplePackage": "N",
"IndicationAndUsage": "helps control plaque that leads to gingivitis."
},
{
"NDCCode": "50804-601-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50804-601-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50804-0601-05",
"ProductNDC": "50804-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Itch Relief",
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021996",
"LabelerName": "PERRIGO DIRECT INC.",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander."
},
{
"NDCCode": "50804-748-03",
"PackageDescription": "9 mL in 1 BOTTLE, WITH APPLICATOR (50804-748-03) ",
"NDC11Code": "50804-0748-03",
"ProductNDC": "50804-748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Wart Remover Liquid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150810",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M028",
"LabelerName": "Perrigo Direct, Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".17",
"StrengthUnit": "g/9mL",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150810",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. Plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern."
},
{
"NDCCode": "50804-749-03",
"PackageDescription": "9.8 mL in 1 BOTTLE, WITH APPLICATOR (50804-749-03) ",
"NDC11Code": "50804-0749-03",
"ProductNDC": "50804-749",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Corn And Callus Remover",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150810",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M030",
"LabelerName": "Geiss, Destin & Dunn, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".17",
"StrengthUnit": "g/9.8mL",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150810",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of corns and calluses. relieves pain by removing corns and calluses."
},
{
"NDCCode": "0264-1915-00",
"PackageDescription": "6 CARTON in 1 CASE (0264-1915-00) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-1915-00",
"ProductNDC": "0264-1915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Procalamine",
"NonProprietaryName": "Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19820506",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018582",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE",
"StrengthNumber": ".21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "0264-1915-07",
"PackageDescription": "6 CARTON in 1 CASE (0264-1915-07) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-1915-07",
"ProductNDC": "0264-1915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Procalamine",
"NonProprietaryName": "Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19820506",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018582",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE",
"StrengthNumber": ".21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19820506",
"SamplePackage": "N"
},
{
"NDCCode": "0480-3493-16",
"PackageDescription": "6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22) ",
"NDC11Code": "00480-3493-16",
"ProductNDC": "0480-3493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cryselle",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075840",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. The light green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP. C21H28O2 MW: 312.45. Ethinyl Estradiol, USP. C20H24O2 MW: 296.40."
},
{
"NDCCode": "0555-9049-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9049-58) / 1 BLISTER PACK in 1 POUCH (0555-9049-79) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9049-58",
"ProductNDC": "0555-9049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cryselle",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20020724",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075840",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20020724",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and pregelatinized corn starch. The light-green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP. C21H28O2 MW: 312.45. Ethinyl Estradiol, USP. C20H24O2 MW: 296.40."
},
{
"NDCCode": "13107-085-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-085-01) ",
"NDC11Code": "13107-0085-01",
"ProductNDC": "13107-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203572",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
"Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "13107-085-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13107-085-05) ",
"NDC11Code": "13107-0085-05",
"ProductNDC": "13107-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203572",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
"Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "13107-085-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (13107-085-10) ",
"NDC11Code": "13107-0085-10",
"ProductNDC": "13107-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203572",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
"Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "13107-085-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (13107-085-99) ",
"NDC11Code": "13107-0085-99",
"ProductNDC": "13107-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203572",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
"Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "14789-125-05",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (14789-125-05) / 2.5 mL in 1 VIAL, GLASS (14789-125-07) ",
"NDC11Code": "14789-0125-05",
"ProductNDC": "14789-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclophosphamide",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216783",
"LabelerName": "Nexus Pharmaceuticals, LLC",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260330",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: 1 Malignant Diseases:malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1.1) .",
"Description": "Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide has a molecular formula of C 7H 15C l2N 2O 2PH 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 500 mg and 1 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 1.55 g Ethanol, 0.085 g Propylene Glycol, 0.085 g Polyethylene glycol 400 and 0.345 mg Monothioglycerol., 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3.1 g Ethanol, 0.17 g Propylene Glycol, 0.17 g Polyethylene glycol 400, and 0.69 mg Monothioglycerol."
},
{
"NDCCode": "14789-126-05",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (14789-126-05) / 5 mL in 1 VIAL, GLASS (14789-126-07) ",
"NDC11Code": "14789-0126-05",
"ProductNDC": "14789-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclophosphamide",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216783",
"LabelerName": "Nexus Pharmaceuticals, LLC",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260330",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: 1 Malignant Diseases:malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1.1) .",
"Description": "Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide has a molecular formula of C 7H 15C l2N 2O 2PH 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 500 mg and 1 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 1.55 g Ethanol, 0.085 g Propylene Glycol, 0.085 g Polyethylene glycol 400 and 0.345 mg Monothioglycerol., 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3.1 g Ethanol, 0.17 g Propylene Glycol, 0.17 g Polyethylene glycol 400, and 0.69 mg Monothioglycerol."
},
{
"NDCCode": "16714-365-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (16714-365-01) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0365-01",
"ProductNDC": "16714-365",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elinest",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20120107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091105",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120107",
"SamplePackage": "N",
"IndicationAndUsage": "ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.Each pill pack contains 21 pale pink active tablets and 7 white inert tablets."
},
{
"NDCCode": "16714-365-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-365-02) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0365-02",
"ProductNDC": "16714-365",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elinest",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20120107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091105",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120107",
"SamplePackage": "N",
"IndicationAndUsage": "ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.Each pill pack contains 21 pale pink active tablets and 7 white inert tablets."
},
{
"NDCCode": "16714-365-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (16714-365-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0365-03",
"ProductNDC": "16714-365",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elinest",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20120107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091105",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120107",
"SamplePackage": "N",
"IndicationAndUsage": "ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.Each pill pack contains 21 pale pink active tablets and 7 white inert tablets."
},
{
"NDCCode": "16714-365-04",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (16714-365-04) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0365-04",
"ProductNDC": "16714-365",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elinest",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20120107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091105",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120107",
"SamplePackage": "N",
"IndicationAndUsage": "ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.Each pill pack contains 21 pale pink active tablets and 7 white inert tablets."
},
{
"NDCCode": "21922-085-06",
"PackageDescription": "1 TUBE in 1 CARTON (21922-085-06) / 42.5 g in 1 TUBE",
"NDC11Code": "21922-0085-06",
"ProductNDC": "21922-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Vaginal",
"NonProprietaryName": "Estradiol",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20250814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209767",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "ESTRADIOL HEMIHYDRATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250814",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Vaginal Cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.",
"Description": "Each gram of estradiol vaginal cream USP, 0.01% contains 0.1 mg estradiol (as estradiol hemihydrate) in a nonliquefying base containing propylene glycol, methylparaben, sodium lauryl sulfate, mono- and diglycerides, stearyl alcohol, ceresin wax, tert-butylhydroquinone, disodium EDTA, hypromellose, and purified water. Estradiol hemihydrate is chemically described as estra-1,3,5(10)-triene-3,17 β-diol hemihydrate. It has an empirical formula of C18H24O2 . ½H O and molecular weight of 272.37. The structural formula is."
},
{
"NDCCode": "33342-085-07",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-085-07) ",
"NDC11Code": "33342-0085-07",
"ProductNDC": "33342-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20150227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203044",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150227",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2."
},
{
"NDCCode": "33342-085-11",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-085-11) ",
"NDC11Code": "33342-0085-11",
"ProductNDC": "33342-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20150227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203044",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150227",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2."
},
{
"NDCCode": "33342-085-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-085-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "33342-0085-12",
"ProductNDC": "33342-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20150227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203044",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150227",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2."
},
{
"NDCCode": "33342-085-15",
"PackageDescription": "500 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-085-15) ",
"NDC11Code": "33342-0085-15",
"ProductNDC": "33342-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20150227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203044",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150227",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2."
},
{
"NDCCode": "49967-085-01",
"PackageDescription": "143 g in 1 BOTTLE, SPRAY (49967-085-01)",
"NDC11Code": "49967-0085-01",
"ProductNDC": "49967-085",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay",
"ProprietaryNameSuffix": "Anthelios 30 Ultralight Sunscreen",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "4.29; 17.16; 7.17; 10.01; 8.58",
"StrengthUnit": "g/143g; g/143g; g/143g; g/143g; g/143g",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50804-085-17</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (50804-085-17) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>50804-0085-17</NDC11Code>
<ProductNDC>50804-085</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Allergy 24 Hour</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20150619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078104</ApplicationNumber>
<LabelerName>Geiss, Destin & Dunn Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>55</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies: : 1 ■nasal congestion , 2 ■runny nose , 3 ■sneezing, 4 ■itchy nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-112-17</NDCCode>
<PackageDescription>150 TABLET, CHEWABLE in 1 BOTTLE (50804-112-17) </PackageDescription>
<NDC11Code>50804-0112-17</NDC11Code>
<ProductNDC>50804-112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Goodsense Regular Strength Antacid</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231207</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>GoodSense</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-113-17</NDCCode>
<PackageDescription>150 TABLET, CHEWABLE in 1 BOTTLE (50804-113-17) </PackageDescription>
<NDC11Code>50804-0113-17</NDC11Code>
<ProductNDC>50804-113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Goodsense Regular Strength Antacid Peppermint</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>GoodSense</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-007-01</NDCCode>
<PackageDescription>.4 mL in 1 POUCH (50804-007-01) </PackageDescription>
<NDC11Code>50804-0007-01</NDC11Code>
<ProductNDC>50804-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Goodsense Alcohol Swabs</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Geiss, Destin and Dunn</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Wipe injection site vigorously and discard.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-311-15</NDCCode>
<PackageDescription>420 mL in 1 BOTTLE, PLASTIC (50804-311-15) </PackageDescription>
<NDC11Code>50804-0311-15</NDC11Code>
<ProductNDC>50804-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Everyday Clean</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Perrigo Direct, Inc.</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-318-13</NDCCode>
<PackageDescription>1250 mL in 1 BOTTLE, PLASTIC (50804-318-13) </PackageDescription>
<NDC11Code>50804-0318-13</NDC11Code>
<ProductNDC>50804-318</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic</ProprietaryName>
<NonProprietaryName>Eucayptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Perrigo Direct, Inc.</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-318-69</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (50804-318-69) </PackageDescription>
<NDC11Code>50804-0318-69</NDC11Code>
<ProductNDC>50804-318</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic</ProprietaryName>
<NonProprietaryName>Eucayptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Perrigo Direct, Inc.</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-601-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (50804-601-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50804-0601-05</NDC11Code>
<ProductNDC>50804-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eye Itch Relief</ProprietaryName>
<NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021996</ApplicationNumber>
<LabelerName>PERRIGO DIRECT INC.</LabelerName>
<SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-748-03</NDCCode>
<PackageDescription>9 mL in 1 BOTTLE, WITH APPLICATOR (50804-748-03) </PackageDescription>
<NDC11Code>50804-0748-03</NDC11Code>
<ProductNDC>50804-748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Wart Remover Liquid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M028</ApplicationNumber>
<LabelerName>Perrigo Direct, Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.17</StrengthNumber>
<StrengthUnit>g/9mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. Plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-749-03</NDCCode>
<PackageDescription>9.8 mL in 1 BOTTLE, WITH APPLICATOR (50804-749-03) </PackageDescription>
<NDC11Code>50804-0749-03</NDC11Code>
<ProductNDC>50804-749</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Corn And Callus Remover</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M030</ApplicationNumber>
<LabelerName>Geiss, Destin & Dunn, Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.17</StrengthNumber>
<StrengthUnit>g/9.8mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of corns and calluses. relieves pain by removing corns and calluses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0264-1915-00</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-1915-00) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1915-00</NDC11Code>
<ProductNDC>0264-1915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Procalamine</ProprietaryName>
<NonProprietaryName>Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19820506</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018582</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE</SubstanceName>
<StrengthNumber>.21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0264-1915-07</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-1915-07) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1915-07</NDC11Code>
<ProductNDC>0264-1915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Procalamine</ProprietaryName>
<NonProprietaryName>Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19820506</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018582</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE</SubstanceName>
<StrengthNumber>.21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0480-3493-16</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22) </PackageDescription>
<NDC11Code>00480-3493-16</NDC11Code>
<ProductNDC>0480-3493</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cryselle</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075840</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. The light green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP. C21H28O2 MW: 312.45. Ethinyl Estradiol, USP. C20H24O2 MW: 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0555-9049-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9049-58) / 1 BLISTER PACK in 1 POUCH (0555-9049-79) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9049-58</NDC11Code>
<ProductNDC>0555-9049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cryselle</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20020724</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075840</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20020724</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and pregelatinized corn starch. The light-green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP. C21H28O2 MW: 312.45. Ethinyl Estradiol, USP. C20H24O2 MW: 296.40.</Description>
</NDC>
<NDC>
<NDCCode>13107-085-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-085-01) </PackageDescription>
<NDC11Code>13107-0085-01</NDC11Code>
<ProductNDC>13107-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203572</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
<Description>Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>13107-085-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13107-085-05) </PackageDescription>
<NDC11Code>13107-0085-05</NDC11Code>
<ProductNDC>13107-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203572</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
<Description>Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>13107-085-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (13107-085-10) </PackageDescription>
<NDC11Code>13107-0085-10</NDC11Code>
<ProductNDC>13107-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203572</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
<Description>Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>13107-085-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (13107-085-99) </PackageDescription>
<NDC11Code>13107-0085-99</NDC11Code>
<ProductNDC>13107-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203572</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
<Description>Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>14789-125-05</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (14789-125-05) / 2.5 mL in 1 VIAL, GLASS (14789-125-07) </PackageDescription>
<NDC11Code>14789-0125-05</NDC11Code>
<ProductNDC>14789-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclophosphamide</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216783</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: 1 Malignant Diseases:malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1.1) .</IndicationAndUsage>
<Description>Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide has a molecular formula of C 7H 15C l2N 2O 2PH 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 500 mg and 1 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 1.55 g Ethanol, 0.085 g Propylene Glycol, 0.085 g Polyethylene glycol 400 and 0.345 mg Monothioglycerol., 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3.1 g Ethanol, 0.17 g Propylene Glycol, 0.17 g Polyethylene glycol 400, and 0.69 mg Monothioglycerol.</Description>
</NDC>
<NDC>
<NDCCode>14789-126-05</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (14789-126-05) / 5 mL in 1 VIAL, GLASS (14789-126-07) </PackageDescription>
<NDC11Code>14789-0126-05</NDC11Code>
<ProductNDC>14789-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclophosphamide</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216783</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: 1 Malignant Diseases:malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1.1) .</IndicationAndUsage>
<Description>Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide has a molecular formula of C 7H 15C l2N 2O 2PH 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 500 mg and 1 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 1.55 g Ethanol, 0.085 g Propylene Glycol, 0.085 g Polyethylene glycol 400 and 0.345 mg Monothioglycerol., 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3.1 g Ethanol, 0.17 g Propylene Glycol, 0.17 g Polyethylene glycol 400, and 0.69 mg Monothioglycerol.</Description>
</NDC>
<NDC>
<NDCCode>16714-365-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (16714-365-01) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0365-01</NDC11Code>
<ProductNDC>16714-365</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elinest</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091105</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.Each pill pack contains 21 pale pink active tablets and 7 white inert tablets.</Description>
</NDC>
<NDC>
<NDCCode>16714-365-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (16714-365-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0365-02</NDC11Code>
<ProductNDC>16714-365</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elinest</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091105</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.Each pill pack contains 21 pale pink active tablets and 7 white inert tablets.</Description>
</NDC>
<NDC>
<NDCCode>16714-365-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (16714-365-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0365-03</NDC11Code>
<ProductNDC>16714-365</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elinest</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091105</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.Each pill pack contains 21 pale pink active tablets and 7 white inert tablets.</Description>
</NDC>
<NDC>
<NDCCode>16714-365-04</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (16714-365-04) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0365-04</NDC11Code>
<ProductNDC>16714-365</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elinest</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091105</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.Each pill pack contains 21 pale pink active tablets and 7 white inert tablets.</Description>
</NDC>
<NDC>
<NDCCode>21922-085-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-085-06) / 42.5 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0085-06</NDC11Code>
<ProductNDC>21922-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Vaginal</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20250814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209767</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>ESTRADIOL HEMIHYDRATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Vaginal Cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.</IndicationAndUsage>
<Description>Each gram of estradiol vaginal cream USP, 0.01% contains 0.1 mg estradiol (as estradiol hemihydrate) in a nonliquefying base containing propylene glycol, methylparaben, sodium lauryl sulfate, mono- and diglycerides, stearyl alcohol, ceresin wax, tert-butylhydroquinone, disodium EDTA, hypromellose, and purified water. Estradiol hemihydrate is chemically described as estra-1,3,5(10)-triene-3,17 β-diol hemihydrate. It has an empirical formula of C18H24O2 . ½H O and molecular weight of 272.37. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>33342-085-07</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-085-07) </PackageDescription>
<NDC11Code>33342-0085-07</NDC11Code>
<ProductNDC>33342-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203044</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>33342-085-11</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-085-11) </PackageDescription>
<NDC11Code>33342-0085-11</NDC11Code>
<ProductNDC>33342-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203044</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>33342-085-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-085-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0085-12</NDC11Code>
<ProductNDC>33342-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203044</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>33342-085-15</NDCCode>
<PackageDescription>500 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-085-15) </PackageDescription>
<NDC11Code>33342-0085-15</NDC11Code>
<ProductNDC>33342-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203044</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>49967-085-01</NDCCode>
<PackageDescription>143 g in 1 BOTTLE, SPRAY (49967-085-01)</PackageDescription>
<NDC11Code>49967-0085-01</NDC11Code>
<ProductNDC>49967-085</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay</ProprietaryName>
<ProprietaryNameSuffix>Anthelios 30 Ultralight Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>4.29; 17.16; 7.17; 10.01; 8.58</StrengthNumber>
<StrengthUnit>g/143g; g/143g; g/143g; g/143g; g/143g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>