{
"NDC": [
{
"NDCCode": "37205-381-67",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (37205-381-67) > 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "37205-0381-67",
"ProductNDC": "37205-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20040225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075990",
"LabelerName": "Cardinal Health",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "37205-381-53",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (37205-381-53) > 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "37205-0381-53",
"ProductNDC": "37205-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20040225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075990",
"LabelerName": "Cardinal Health",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63824-381-67",
"PackageDescription": "200 mL in 1 BOTTLE, PUMP (63824-381-67)",
"NDC11Code": "63824-0381-67",
"ProductNDC": "63824-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clearasil Ultra",
"ProprietaryNameSuffix": "Rapid Action Daily Wash",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120721",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "37205-370-67",
"PackageDescription": "1 BOTTLE in 1 CARTON (37205-370-67) > 48 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "37205-0370-67",
"ProductNDC": "37205-370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Anti Diarrheal",
"NonProprietaryName": "Loperamide Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030402",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Cardinal Health",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050119",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "37205-625-67",
"PackageDescription": "48 APPLICATOR in 1 PACKAGE (37205-625-67) > 4.5 mL in 1 APPLICATOR",
"NDC11Code": "37205-0625-67",
"ProductNDC": "37205-625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Medicated Wipes",
"NonProprietaryName": "Witch Hazel",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100413",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Cardinal Health",
"SubstanceName": "WITCH HAZEL",
"StrengthNumber": ".5",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "37205-741-67",
"PackageDescription": "48 SOLUTION in 1 POUCH (37205-741-67)",
"NDC11Code": "37205-0741-67",
"ProductNDC": "37205-741",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Medicated Wipe",
"NonProprietaryName": "Witch Hazel",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "CARDINAL HEALTH",
"SubstanceName": "WITCH HAZEL",
"StrengthNumber": "5",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Directions. Adults and children 12 years and older, up to 6 times daily or after each bowel movement. Children under 12, consult a doctor. When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. Gently apply to the affected area by patting and discard. Apply to the affected area up to 6 times daily or after each bowel movement."
},
{
"NDCCode": "43547-381-03",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-03) ",
"NDC11Code": "43547-0381-03",
"ProductNDC": "43547-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206653",
"LabelerName": "Solco Healthcare US, LLC",
"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": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160120",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults .",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) 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 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, gelatin, hypromellose acetate succinate, hypromellose, macrogol/peg, polyvinyl alcohol-part hydrolyzed, sodium hydroxide, sucrose, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethyl citrate. The 30 mg capsules also contain D&C Yellow 10 and FD&C Blue 1. The 60 mg capsules also contain FD&C Blue 1 and FD&C Red 40."
},
{
"NDCCode": "43547-381-09",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-09) ",
"NDC11Code": "43547-0381-09",
"ProductNDC": "43547-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206653",
"LabelerName": "Solco Healthcare US, LLC",
"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": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160120",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults .",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) 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 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, gelatin, hypromellose acetate succinate, hypromellose, macrogol/peg, polyvinyl alcohol-part hydrolyzed, sodium hydroxide, sucrose, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethyl citrate. The 30 mg capsules also contain D&C Yellow 10 and FD&C Blue 1. The 60 mg capsules also contain FD&C Blue 1 and FD&C Red 40."
},
{
"NDCCode": "43547-381-11",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-11) ",
"NDC11Code": "43547-0381-11",
"ProductNDC": "43547-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206653",
"LabelerName": "Solco Healthcare US, LLC",
"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": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160120",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults .",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) 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 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, gelatin, hypromellose acetate succinate, hypromellose, macrogol/peg, polyvinyl alcohol-part hydrolyzed, sodium hydroxide, sucrose, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethyl citrate. The 30 mg capsules also contain D&C Yellow 10 and FD&C Blue 1. The 60 mg capsules also contain FD&C Blue 1 and FD&C Red 40."
},
{
"NDCCode": "47335-381-08",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-08) ",
"NDC11Code": "47335-0381-08",
"ProductNDC": "47335-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090745",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "47335-381-18",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-18) ",
"NDC11Code": "47335-0381-18",
"ProductNDC": "47335-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090745",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "47335-381-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (47335-381-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "47335-0381-61",
"ProductNDC": "47335-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090745",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "47335-381-83",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-83) ",
"NDC11Code": "47335-0381-83",
"ProductNDC": "47335-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090745",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "47335-381-86",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-86) ",
"NDC11Code": "47335-0381-86",
"ProductNDC": "47335-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090745",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "47335-381-88",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-88) ",
"NDC11Code": "47335-0381-88",
"ProductNDC": "47335-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090745",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "59746-564-67",
"PackageDescription": "400 CAPSULE in 1 BOTTLE (59746-564-67) ",
"NDC11Code": "59746-0564-67",
"ProductNDC": "59746-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207061",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170404",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular formula is C17H14F3N3O2S, and the molecular weight is 381.37; the chemical structure is as follows. Celecoxib USP is a white or almost white, crystalline or amorphous powder. It is soluble in ethanol, methylene chloride and is practically insoluble in water. Celecoxib capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib USP, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate. The 50 mg, 100 mg, 200 mg and 400 mg capsule shell contains: gelatin and titanium dioxide. The printing ink contains: shellac and propylene glycol, in addition 50 mg capsule printing ink contains ferric oxide red, 100 mg capsule printing ink contains FD&C blue #2 aluminum lake, 200 mg capsule printing ink contains ferric oxide yellow, 400 mg capsule printing ink contains FD&C blue #2 aluminum lake, ferric oxide yellow, and titanium dioxide."
},
{
"NDCCode": "68382-105-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-105-06) ",
"NDC11Code": "68382-0105-06",
"ProductNDC": "68382-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230103",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-105-16",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-105-16) ",
"NDC11Code": "68382-0105-16",
"ProductNDC": "68382-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230103",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-469-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-469-06) ",
"NDC11Code": "68382-0469-06",
"ProductNDC": "68382-469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-469-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-469-10) ",
"NDC11Code": "68382-0469-10",
"ProductNDC": "68382-469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-469-16",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-469-16) ",
"NDC11Code": "68382-0469-16",
"ProductNDC": "68382-469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-469-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-469-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-469-30) ",
"NDC11Code": "68382-0469-77",
"ProductNDC": "68382-469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-741-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-741-06) ",
"NDC11Code": "68382-0741-06",
"ProductNDC": "68382-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-741-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-741-10) ",
"NDC11Code": "68382-0741-10",
"ProductNDC": "68382-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-741-16",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-741-16) ",
"NDC11Code": "68382-0741-16",
"ProductNDC": "68382-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "68382-741-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-741-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-741-30) ",
"NDC11Code": "68382-0741-77",
"ProductNDC": "68382-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204020",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).",
"Description": "Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake."
},
{
"NDCCode": "37205-008-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (37205-008-05) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "37205-0008-05",
"ProductNDC": "37205-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Pain Reliever",
"ProprietaryNameSuffix": "Infants Concentrated",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "19900515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Cardinal Health",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "80",
"StrengthUnit": "mg/.8mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "37205-009-16",
"PackageDescription": "59 mL in 1 BOTTLE (37205-009-16) ",
"NDC11Code": "37205-0009-16",
"ProductNDC": "37205-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Camphor Spirit",
"NonProprietaryName": "Camphor (natural)",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180830",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Cardinal Health",
"SubstanceName": "CAMPHOR (NATURAL)",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180830",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N"
},
{
"NDCCode": "37205-012-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (37205-012-43) ",
"NDC11Code": "37205-0012-43",
"ProductNDC": "37205-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Rubbing Alcohol",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120509",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Cardinal Health",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150509",
"SamplePackage": "N"
},
{
"NDCCode": "37205-012-45",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (37205-012-45) ",
"NDC11Code": "37205-0012-45",
"ProductNDC": "37205-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Rubbing Alcohol",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120509",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Cardinal Health",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150509",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>37205-381-67</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (37205-381-67) > 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37205-0381-67</NDC11Code>
<ProductNDC>37205-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075990</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37205-381-53</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (37205-381-53) > 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37205-0381-53</NDC11Code>
<ProductNDC>37205-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075990</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63824-381-67</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE, PUMP (63824-381-67)</PackageDescription>
<NDC11Code>63824-0381-67</NDC11Code>
<ProductNDC>63824-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clearasil Ultra</ProprietaryName>
<ProprietaryNameSuffix>Rapid Action Daily Wash</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120721</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37205-370-67</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37205-370-67) > 48 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0370-67</NDC11Code>
<ProductNDC>37205-370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030402</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050119</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37205-625-67</NDCCode>
<PackageDescription>48 APPLICATOR in 1 PACKAGE (37205-625-67) > 4.5 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>37205-0625-67</NDC11Code>
<ProductNDC>37205-625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Medicated Wipes</ProprietaryName>
<NonProprietaryName>Witch Hazel</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>WITCH HAZEL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37205-741-67</NDCCode>
<PackageDescription>48 SOLUTION in 1 POUCH (37205-741-67)</PackageDescription>
<NDC11Code>37205-0741-67</NDC11Code>
<ProductNDC>37205-741</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Medicated Wipe</ProprietaryName>
<NonProprietaryName>Witch Hazel</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>CARDINAL HEALTH</LabelerName>
<SubstanceName>WITCH HAZEL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Adults and children 12 years and older, up to 6 times daily or after each bowel movement. Children under 12, consult a doctor. When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. Gently apply to the affected area by patting and discard. Apply to the affected area up to 6 times daily or after each bowel movement.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43547-381-03</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-03) </PackageDescription>
<NDC11Code>43547-0381-03</NDC11Code>
<ProductNDC>43547-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206653</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</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>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults .</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) 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 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, gelatin, hypromellose acetate succinate, hypromellose, macrogol/peg, polyvinyl alcohol-part hydrolyzed, sodium hydroxide, sucrose, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethyl citrate. The 30 mg capsules also contain D&C Yellow 10 and FD&C Blue 1. The 60 mg capsules also contain FD&C Blue 1 and FD&C Red 40.</Description>
</NDC>
<NDC>
<NDCCode>43547-381-09</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-09) </PackageDescription>
<NDC11Code>43547-0381-09</NDC11Code>
<ProductNDC>43547-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206653</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</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>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults .</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) 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 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, gelatin, hypromellose acetate succinate, hypromellose, macrogol/peg, polyvinyl alcohol-part hydrolyzed, sodium hydroxide, sucrose, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethyl citrate. The 30 mg capsules also contain D&C Yellow 10 and FD&C Blue 1. The 60 mg capsules also contain FD&C Blue 1 and FD&C Red 40.</Description>
</NDC>
<NDC>
<NDCCode>43547-381-11</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-11) </PackageDescription>
<NDC11Code>43547-0381-11</NDC11Code>
<ProductNDC>43547-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206653</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</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>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults .</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) 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 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, gelatin, hypromellose acetate succinate, hypromellose, macrogol/peg, polyvinyl alcohol-part hydrolyzed, sodium hydroxide, sucrose, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethyl citrate. The 30 mg capsules also contain D&C Yellow 10 and FD&C Blue 1. The 60 mg capsules also contain FD&C Blue 1 and FD&C Red 40.</Description>
</NDC>
<NDC>
<NDCCode>47335-381-08</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-08) </PackageDescription>
<NDC11Code>47335-0381-08</NDC11Code>
<ProductNDC>47335-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090745</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>47335-381-18</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-18) </PackageDescription>
<NDC11Code>47335-0381-18</NDC11Code>
<ProductNDC>47335-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090745</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>47335-381-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (47335-381-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47335-0381-61</NDC11Code>
<ProductNDC>47335-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090745</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>47335-381-83</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-83) </PackageDescription>
<NDC11Code>47335-0381-83</NDC11Code>
<ProductNDC>47335-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090745</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>47335-381-86</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-86) </PackageDescription>
<NDC11Code>47335-0381-86</NDC11Code>
<ProductNDC>47335-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090745</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>47335-381-88</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-88) </PackageDescription>
<NDC11Code>47335-0381-88</NDC11Code>
<ProductNDC>47335-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090745</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules USP are indicated for the treatment of:. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, or 60 mg of duloxetine (equivalent to 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>59746-564-67</NDCCode>
<PackageDescription>400 CAPSULE in 1 BOTTLE (59746-564-67) </PackageDescription>
<NDC11Code>59746-0564-67</NDC11Code>
<ProductNDC>59746-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207061</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular formula is C17H14F3N3O2S, and the molecular weight is 381.37; the chemical structure is as follows. Celecoxib USP is a white or almost white, crystalline or amorphous powder. It is soluble in ethanol, methylene chloride and is practically insoluble in water. Celecoxib capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib USP, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate. The 50 mg, 100 mg, 200 mg and 400 mg capsule shell contains: gelatin and titanium dioxide. The printing ink contains: shellac and propylene glycol, in addition 50 mg capsule printing ink contains ferric oxide red, 100 mg capsule printing ink contains FD&C blue #2 aluminum lake, 200 mg capsule printing ink contains ferric oxide yellow, 400 mg capsule printing ink contains FD&C blue #2 aluminum lake, ferric oxide yellow, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68382-105-06</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-105-06) </PackageDescription>
<NDC11Code>68382-0105-06</NDC11Code>
<ProductNDC>68382-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-105-16</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-105-16) </PackageDescription>
<NDC11Code>68382-0105-16</NDC11Code>
<ProductNDC>68382-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-469-06</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-469-06) </PackageDescription>
<NDC11Code>68382-0469-06</NDC11Code>
<ProductNDC>68382-469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-469-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-469-10) </PackageDescription>
<NDC11Code>68382-0469-10</NDC11Code>
<ProductNDC>68382-469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-469-16</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-469-16) </PackageDescription>
<NDC11Code>68382-0469-16</NDC11Code>
<ProductNDC>68382-469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-469-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-469-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-469-30) </PackageDescription>
<NDC11Code>68382-0469-77</NDC11Code>
<ProductNDC>68382-469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-741-06</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-741-06) </PackageDescription>
<NDC11Code>68382-0741-06</NDC11Code>
<ProductNDC>68382-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-741-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-741-10) </PackageDescription>
<NDC11Code>68382-0741-10</NDC11Code>
<ProductNDC>68382-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-741-16</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-741-16) </PackageDescription>
<NDC11Code>68382-0741-16</NDC11Code>
<ProductNDC>68382-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-741-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-741-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-741-30) </PackageDescription>
<NDC11Code>68382-0741-77</NDC11Code>
<ProductNDC>68382-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204020</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablet for oral administration contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the molecular formula of C16H25NO2 (free base) and C16H25NO2C4H6O4 (succinate anhydrous). Desvenlafaxine succinate anhydrous has a molecular weight of 381.48. The structural formula is shown below. Desvenlafaxine succinate, USP is a white to off-white crystalline powder that is soluble in water and slightly soluble in tetrahydrofuran. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 37.92 mg or 75.84 mg or 151.67 mg of desvenlafaxine succinate equivalent to 25 mg or 50 mg or 100 mg of desvenlafaxine, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, titanium dioxide and xanthan gum. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow and each 100 mg tablet contains FD&C yellow # 6 aluminium lake and FD&C red # 40 aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>37205-008-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (37205-008-05) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>37205-0008-05</NDC11Code>
<ProductNDC>37205-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Pain Reliever</ProprietaryName>
<ProprietaryNameSuffix>Infants Concentrated</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/.8mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37205-009-16</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (37205-009-16) </PackageDescription>
<NDC11Code>37205-0009-16</NDC11Code>
<ProductNDC>37205-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Camphor Spirit</ProprietaryName>
<NonProprietaryName>Camphor (natural)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180830</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CAMPHOR (NATURAL)</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180830</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37205-012-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (37205-012-43) </PackageDescription>
<NDC11Code>37205-0012-43</NDC11Code>
<ProductNDC>37205-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Rubbing Alcohol</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120509</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37205-012-45</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (37205-012-45) </PackageDescription>
<NDC11Code>37205-0012-45</NDC11Code>
<ProductNDC>37205-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Rubbing Alcohol</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120509</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>