{
"NDC": [
{
"NDCCode": "72587-111-22",
"PackageDescription": "4 PATCH in 1 POUCH (72587-111-22) / .009 g in 1 PATCH",
"NDC11Code": "72587-0111-22",
"ProductNDC": "72587-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothe",
"NonProprietaryName": "Capsaicin, Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "La Mend, Inc.",
"SubstanceName": "CAPSAICIN; MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": ".25; 5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181001",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with. simple backache arthritis strains bruises sprains."
},
{
"NDCCode": "72587-110-22",
"PackageDescription": "4 PATCH in 1 POUCH (72587-110-22) > .05 g in 1 PATCH",
"NDC11Code": "72587-0110-22",
"ProductNDC": "72587-110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cycle",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "La Mend, Inc.",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N"
},
{
"NDCCode": "24909-111-22",
"PackageDescription": "2 CYLINDER in 1 CARTON (24909-111-22) > 2 g in 1 CYLINDER",
"NDC11Code": "24909-0111-22",
"ProductNDC": "24909-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Wart Removal",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120907",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358B",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "12",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "For the removal of common warts. The common wart iseasily recognized by the rough “cauliflower-like” appearance of thesurface. For the removal of plantar warts on the bottom of thefoot. The plantar wart is recognized by its location only on the bottom of thefoot, its tenderness, and the interruption of the footprint pattern."
},
{
"NDCCode": "43074-111-22",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (43074-111-22) > 3 mL in 1 BOTTLE, DROPPER (43074-111-21)",
"NDC11Code": "43074-0111-22",
"ProductNDC": "43074-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermoneen",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110106",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Phillips Company",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".02",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "43744-111-22",
"PackageDescription": "20 g in 1 DRUM (43744-111-22)",
"NDC11Code": "43744-0111-22",
"ProductNDC": "43744-111",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110707",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "63354-111-22",
"PackageDescription": "88 g in 1 TUBE (63354-111-22)",
"NDC11Code": "63354-0111-22",
"ProductNDC": "63354-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Banana Boat",
"NonProprietaryName": "Avobenzone, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Energizer Personal Care LLC",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 6; 4",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-10-05"
},
{
"NDCCode": "67091-111-22",
"PackageDescription": "222 mL in 1 BOTTLE, PLASTIC (67091-111-22) ",
"NDC11Code": "67091-0111-22",
"ProductNDC": "67091-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Winco Citrus Lhs",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "WINCO FOODS, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "130",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "Helps eliminate bacteria on hands."
},
{
"NDCCode": "72113-111-22",
"PackageDescription": "1 CONTAINER in 1 CARTON (72113-111-22) / 15 g in 1 CONTAINER",
"NDC11Code": "72113-0111-22",
"ProductNDC": "72113-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tri-water Sheer Mineral Sunscreen Cushion Spf30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "SPONGE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Eden Brands Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "188",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241218",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sun protection measures (see DIRECTIONS), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "75446-111-22",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (75446-111-22) ",
"NDC11Code": "75446-0111-22",
"ProductNDC": "75446-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medshield Products",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200427",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "HWL Holdings, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "ug/mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200427",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease."
},
{
"NDCCode": "80220-111-22",
"PackageDescription": "500 mL in 1 BOTTLE, DISPENSING (80220-111-22) ",
"NDC11Code": "80220-0111-22",
"ProductNDC": "80220-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200907",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Bevco, S. de R.L de C.V.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200907",
"SamplePackage": "N"
},
{
"NDCCode": "80466-111-05",
"PackageDescription": "22.7 kg in 1 PAIL (80466-111-05) ",
"NDC11Code": "80466-0111-05",
"ProductNDC": "80466-111",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "SUSPENSION",
"StartMarketingDate": "20190516",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Vantage Specialty Ingredients, Inc.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".7",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "16-MAY-19"
},
{
"NDCCode": "83983-111-02",
"PackageDescription": "22.5 L in 1 PAIL (83983-111-02) ",
"NDC11Code": "83983-0111-02",
"ProductNDC": "83983-111",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240117",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Taicang Xintai Alcohol Co Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "100",
"StrengthUnit": "L/100L",
"Status": "Unfinished",
"LastUpdate": "2024-01-19",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "17-JAN-24"
},
{
"NDCCode": "0049-0050-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00049-0050-01",
"ProductNDC": "0049-0050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20170106",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020990",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170106",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4900-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30) ",
"NDC11Code": "00049-4900-30",
"ProductNDC": "0049-4900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4900-41",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00049-4900-41",
"ProductNDC": "0049-4900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4910-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0049-4910-30) ",
"NDC11Code": "00049-4910-30",
"ProductNDC": "0049-4910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4910-41",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0049-4910-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00049-4910-41",
"ProductNDC": "0049-4910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4960-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0049-4960-30) ",
"NDC11Code": "00049-4960-30",
"ProductNDC": "0049-4960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "11014-0225-1",
"PackageDescription": "1 BAG in 1 CONTAINER (11014-0225-1) > 548528 CAPSULE in 1 BAG",
"NDC11Code": "11014-0225-01",
"ProductNDC": "11014-0225",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Neevo Dha",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20131001",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; METHYLCOBALAMIN; RIBOFLAVIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; FERROUS SULFATE; PYRIDOXAL PHOSPHATE ANHYDROUS; ASCORBIC ACID; THIAMINE MONONITRATE; CALCIUM CARBONATE; DOCONEXENT; SACCHAROMYCES CEREVISIAE; MAGNESIUM OXIDE; POTASSIUM IODIDE; CHOLECALCIFEROL",
"StrengthNumber": "24.6; 1.42; 1.71; 1.79; 20; 93.2; 30.5; 111.6; 2.08; 308.4; 547.9; 33; 11.4; .32; .22",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "11014-0225-2",
"PackageDescription": "1 BAG in 1 CONTAINER (11014-0225-2) > 959986 CAPSULE in 1 BAG",
"NDC11Code": "11014-0225-02",
"ProductNDC": "11014-0225",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Neevo Dha",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20131001",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; METHYLCOBALAMIN; RIBOFLAVIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; FERROUS SULFATE; PYRIDOXAL PHOSPHATE ANHYDROUS; ASCORBIC ACID; THIAMINE MONONITRATE; CALCIUM CARBONATE; DOCONEXENT; SACCHAROMYCES CEREVISIAE; MAGNESIUM OXIDE; POTASSIUM IODIDE; CHOLECALCIFEROL",
"StrengthNumber": "24.6; 1.42; 1.71; 1.79; 20; 93.2; 30.5; 111.6; 2.08; 308.4; 547.9; 33; 11.4; .32; .22",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "13668-111-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-01) ",
"NDC11Code": "13668-0111-01",
"ProductNDC": "13668-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "13668-111-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-05) ",
"NDC11Code": "13668-0111-05",
"ProductNDC": "13668-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "13668-111-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-30) ",
"NDC11Code": "13668-0111-30",
"ProductNDC": "13668-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "13668-111-74",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 CARTON (13668-111-74) ",
"NDC11Code": "13668-0111-74",
"ProductNDC": "13668-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N"
},
{
"NDCCode": "22700-111-12",
"PackageDescription": "12 g in 1 JAR (22700-111-12)",
"NDC11Code": "22700-0111-12",
"ProductNDC": "22700-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Covergirl Plus Olay",
"ProprietaryNameSuffix": "Simplyageless Foundation Broadspectrum Spf 22 (all Shades)",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120801",
"EndMarketingDate": "20180416",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Noxell",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "49",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-04-16",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "24571-111-05",
"PackageDescription": "2 BAG in 1 CASE (24571-111-05) > 5 L in 1 BAG",
"NDC11Code": "24571-0111-05",
"ProductNDC": "24571-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prismasol",
"ProprietaryNameSuffix": "B22gk4/0",
"NonProprietaryName": "Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061025",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021703",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "3.05; 22; 5.4; 7.07; 2.21; .314",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20081010",
"SamplePackage": "N"
},
{
"NDCCode": "44087-1115-1",
"PackageDescription": "1 PACKAGE in 1 CARTON (44087-1115-1) / .5 mL in 1 PACKAGE",
"NDC11Code": "44087-1115-01",
"ProductNDC": "44087-1115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gonal-f Rff Redi-ject",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021684",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "300",
"StrengthUnit": "[iU]/.5mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).",
"Description": "Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa."
},
{
"NDCCode": "44087-1116-1",
"PackageDescription": "1 PACKAGE in 1 CARTON (44087-1116-1) / .75 mL in 1 PACKAGE",
"NDC11Code": "44087-1116-01",
"ProductNDC": "44087-1116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gonal-f Rff Redi-ject",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021684",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "450",
"StrengthUnit": "[iU]/.75mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).",
"Description": "Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa."
},
{
"NDCCode": "44087-1117-1",
"PackageDescription": "1 PACKAGE in 1 CARTON (44087-1117-1) / 1.5 mL in 1 PACKAGE",
"NDC11Code": "44087-1117-01",
"ProductNDC": "44087-1117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gonal-f Rff Redi-ject",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021684",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "900",
"StrengthUnit": "[iU]/1.5mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).",
"Description": "Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa."
},
{
"NDCCode": "52000-111-01",
"PackageDescription": "181 g in 1 TUBE (52000-111-01) ",
"NDC11Code": "52000-0111-01",
"ProductNDC": "52000-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Universal Anti-cavity Fluoride",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20200530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Universal Distribution Center LLC",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".76",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2023-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200530",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 regular brushing with flouride toothpaste helps protect teeth against cavities , 2 aids in the prevention of dental cavities."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72587-111-22</NDCCode>
<PackageDescription>4 PATCH in 1 POUCH (72587-111-22) / .009 g in 1 PATCH</PackageDescription>
<NDC11Code>72587-0111-22</NDC11Code>
<ProductNDC>72587-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothe</ProprietaryName>
<NonProprietaryName>Capsaicin, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>La Mend, Inc.</LabelerName>
<SubstanceName>CAPSAICIN; MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>.25; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with. simple backache arthritis strains bruises sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72587-110-22</NDCCode>
<PackageDescription>4 PATCH in 1 POUCH (72587-110-22) > .05 g in 1 PATCH</PackageDescription>
<NDC11Code>72587-0110-22</NDC11Code>
<ProductNDC>72587-110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cycle</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>La Mend, Inc.</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24909-111-22</NDCCode>
<PackageDescription>2 CYLINDER in 1 CARTON (24909-111-22) > 2 g in 1 CYLINDER</PackageDescription>
<NDC11Code>24909-0111-22</NDC11Code>
<ProductNDC>24909-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Wart Removal</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120907</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358B</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the removal of common warts. The common wart iseasily recognized by the rough “cauliflower-like” appearance of thesurface. For the removal of plantar warts on the bottom of thefoot. The plantar wart is recognized by its location only on the bottom of thefoot, its tenderness, and the interruption of the footprint pattern.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43074-111-22</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (43074-111-22) > 3 mL in 1 BOTTLE, DROPPER (43074-111-21)</PackageDescription>
<NDC11Code>43074-0111-22</NDC11Code>
<ProductNDC>43074-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermoneen</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Phillips Company</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.02</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43744-111-22</NDCCode>
<PackageDescription>20 g in 1 DRUM (43744-111-22)</PackageDescription>
<NDC11Code>43744-0111-22</NDC11Code>
<ProductNDC>43744-111</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110707</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63354-111-22</NDCCode>
<PackageDescription>88 g in 1 TUBE (63354-111-22)</PackageDescription>
<NDC11Code>63354-0111-22</NDC11Code>
<ProductNDC>63354-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Banana Boat</ProprietaryName>
<NonProprietaryName>Avobenzone, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Energizer Personal Care LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 6; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>67091-111-22</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE, PLASTIC (67091-111-22) </PackageDescription>
<NDC11Code>67091-0111-22</NDC11Code>
<ProductNDC>67091-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Winco Citrus Lhs</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>WINCO FOODS, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps eliminate bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72113-111-22</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (72113-111-22) / 15 g in 1 CONTAINER</PackageDescription>
<NDC11Code>72113-0111-22</NDC11Code>
<ProductNDC>72113-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tri-water Sheer Mineral Sunscreen Cushion Spf30</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>SPONGE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241218</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Eden Brands Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>188</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sun protection measures (see DIRECTIONS), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75446-111-22</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (75446-111-22) </PackageDescription>
<NDC11Code>75446-0111-22</NDC11Code>
<ProductNDC>75446-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medshield Products</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200427</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>HWL Holdings, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80220-111-22</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, DISPENSING (80220-111-22) </PackageDescription>
<NDC11Code>80220-0111-22</NDC11Code>
<ProductNDC>80220-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200907</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Bevco, S. de R.L de C.V.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80466-111-05</NDCCode>
<PackageDescription>22.7 kg in 1 PAIL (80466-111-05) </PackageDescription>
<NDC11Code>80466-0111-05</NDC11Code>
<ProductNDC>80466-111</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<StartMarketingDate>20190516</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Vantage Specialty Ingredients, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-MAY-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>83983-111-02</NDCCode>
<PackageDescription>22.5 L in 1 PAIL (83983-111-02) </PackageDescription>
<NDC11Code>83983-0111-02</NDC11Code>
<ProductNDC>83983-111</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20240117</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Taicang Xintai Alcohol Co Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-19</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-JAN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0049-0050-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00049-0050-01</NDC11Code>
<ProductNDC>0049-0050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170106</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020990</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170106</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4900-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30) </PackageDescription>
<NDC11Code>00049-4900-30</NDC11Code>
<ProductNDC>0049-4900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4900-41</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00049-4900-41</NDC11Code>
<ProductNDC>0049-4900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4910-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-4910-30) </PackageDescription>
<NDC11Code>00049-4910-30</NDC11Code>
<ProductNDC>0049-4910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
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<PackageDescription>100 BLISTER PACK in 1 CARTON (0049-4910-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00049-4910-41</NDC11Code>
<ProductNDC>0049-4910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4960-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-4960-30) </PackageDescription>
<NDC11Code>00049-4960-30</NDC11Code>
<ProductNDC>0049-4960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>11014-0225-1</NDCCode>
<PackageDescription>1 BAG in 1 CONTAINER (11014-0225-1) > 548528 CAPSULE in 1 BAG</PackageDescription>
<NDC11Code>11014-0225-01</NDC11Code>
<ProductNDC>11014-0225</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Neevo Dha</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20131001</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; METHYLCOBALAMIN; RIBOFLAVIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; FERROUS SULFATE; PYRIDOXAL PHOSPHATE ANHYDROUS; ASCORBIC ACID; THIAMINE MONONITRATE; CALCIUM CARBONATE; DOCONEXENT; SACCHAROMYCES CEREVISIAE; MAGNESIUM OXIDE; POTASSIUM IODIDE; CHOLECALCIFEROL</SubstanceName>
<StrengthNumber>24.6; 1.42; 1.71; 1.79; 20; 93.2; 30.5; 111.6; 2.08; 308.4; 547.9; 33; 11.4; .32; .22</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11014-0225-2</NDCCode>
<PackageDescription>1 BAG in 1 CONTAINER (11014-0225-2) > 959986 CAPSULE in 1 BAG</PackageDescription>
<NDC11Code>11014-0225-02</NDC11Code>
<ProductNDC>11014-0225</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Neevo Dha</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20131001</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; METHYLCOBALAMIN; RIBOFLAVIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; FERROUS SULFATE; PYRIDOXAL PHOSPHATE ANHYDROUS; ASCORBIC ACID; THIAMINE MONONITRATE; CALCIUM CARBONATE; DOCONEXENT; SACCHAROMYCES CEREVISIAE; MAGNESIUM OXIDE; POTASSIUM IODIDE; CHOLECALCIFEROL</SubstanceName>
<StrengthNumber>24.6; 1.42; 1.71; 1.79; 20; 93.2; 30.5; 111.6; 2.08; 308.4; 547.9; 33; 11.4; .32; .22</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-111-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-01) </PackageDescription>
<NDC11Code>13668-0111-01</NDC11Code>
<ProductNDC>13668-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
</NDC>
<NDC>
<NDCCode>13668-111-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-05) </PackageDescription>
<NDC11Code>13668-0111-05</NDC11Code>
<ProductNDC>13668-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
</NDC>
<NDC>
<NDCCode>13668-111-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-30) </PackageDescription>
<NDC11Code>13668-0111-30</NDC11Code>
<ProductNDC>13668-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
</NDC>
<NDC>
<NDCCode>13668-111-74</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 CARTON (13668-111-74) </PackageDescription>
<NDC11Code>13668-0111-74</NDC11Code>
<ProductNDC>13668-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>22700-111-12</NDCCode>
<PackageDescription>12 g in 1 JAR (22700-111-12)</PackageDescription>
<NDC11Code>22700-0111-12</NDC11Code>
<ProductNDC>22700-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Covergirl Plus Olay</ProprietaryName>
<ProprietaryNameSuffix>Simplyageless Foundation Broadspectrum Spf 22 (all Shades)</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120801</StartMarketingDate>
<EndMarketingDate>20180416</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Noxell</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>49</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-16</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>24571-111-05</NDCCode>
<PackageDescription>2 BAG in 1 CASE (24571-111-05) > 5 L in 1 BAG</PackageDescription>
<NDC11Code>24571-0111-05</NDC11Code>
<ProductNDC>24571-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prismasol</ProprietaryName>
<ProprietaryNameSuffix>B22gk4/0</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Chloride, Dextrose Monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061025</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021703</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>3.05; 22; 5.4; 7.07; 2.21; .314</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44087-1115-1</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (44087-1115-1) / .5 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>44087-1115-01</NDC11Code>
<ProductNDC>44087-1115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gonal-f Rff Redi-ject</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021684</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>[iU]/.5mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).</IndicationAndUsage>
<Description>Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa.</Description>
</NDC>
<NDC>
<NDCCode>44087-1116-1</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (44087-1116-1) / .75 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>44087-1116-01</NDC11Code>
<ProductNDC>44087-1116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gonal-f Rff Redi-ject</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021684</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>[iU]/.75mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).</IndicationAndUsage>
<Description>Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa.</Description>
</NDC>
<NDC>
<NDCCode>44087-1117-1</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (44087-1117-1) / 1.5 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>44087-1117-01</NDC11Code>
<ProductNDC>44087-1117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gonal-f Rff Redi-ject</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021684</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>[iU]/1.5mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).</IndicationAndUsage>
<Description>Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa.</Description>
</NDC>
<NDC>
<NDCCode>52000-111-01</NDCCode>
<PackageDescription>181 g in 1 TUBE (52000-111-01) </PackageDescription>
<NDC11Code>52000-0111-01</NDC11Code>
<ProductNDC>52000-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Universal Anti-cavity Fluoride</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20200530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Universal Distribution Center LLC</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.76</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 regular brushing with flouride toothpaste helps protect teeth against cavities , 2 aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
</NDCList>