{
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250930",
"SamplePackage": "N",
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"ProductNDC": "69230-333",
"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "TABLET",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219102",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "LEVONORGESTREL",
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"StrengthUnit": "mg/1",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)."
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{
"NDCCode": "69230-333-34",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (69230-333-34) / 1 TABLET in 1 BLISTER PACK",
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"ProductNDC": "69230-333",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Levonorgestrel",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219102",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)."
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{
"NDCCode": "76772-010-33",
"PackageDescription": "333 mL in 1 BOTTLE (76772-010-33) ",
"NDC11Code": "76772-0010-33",
"ProductNDC": "76772-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI",
"SubstanceName": "BENZALKONIUM CHLORIDE",
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"StrengthUnit": "g/mL",
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"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "76772-012-33",
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"NDC11Code": "76772-0012-33",
"ProductNDC": "76772-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "69230-318-33",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (69230-318-33) > 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "69230-0318-33",
"ProductNDC": "69230-318",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211732",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200325",
"SamplePackage": "N",
"IndicationAndUsage": " treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "69230-320-33",
"PackageDescription": "3 BOTTLE in 1 CARTON (69230-320-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "69230-0320-33",
"ProductNDC": "69230-320",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212507",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200602",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "69230-321-33",
"PackageDescription": "1 BOTTLE in 1 CARTON (69230-321-33) > 80 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "69230-0321-33",
"ProductNDC": "69230-321",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213513",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2020-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201028",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat."
},
{
"NDCCode": "69230-323-33",
"PackageDescription": "1 BOTTLE in 1 CARTON (69230-323-33) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "69230-0323-33",
"ProductNDC": "69230-323",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211718",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230728",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
},
{
"NDCCode": "69230-324-33",
"PackageDescription": "10 PACKET in 1 CARTON (69230-324-33) / 17 g in 1 PACKET",
"NDC11Code": "69230-0324-33",
"ProductNDC": "69230-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polyethylene Glycol 3350",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214990",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210414",
"SamplePackage": "N",
"IndicationAndUsage": " relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "69230-326-33",
"PackageDescription": "7 POUCH in 1 DRUM (69230-326-33) / 10000 TABLET, FILM COATED in 1 POUCH",
"NDC11Code": "69230-0326-33",
"ProductNDC": "69230-326",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20211108",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-01-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "08-NOV-21"
},
{
"NDCCode": "69230-327-33",
"PackageDescription": "7 POUCH in 1 DRUM (69230-327-33) / 10000 TABLET, FILM COATED in 1 POUCH",
"NDC11Code": "69230-0327-33",
"ProductNDC": "69230-327",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20211108",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-01-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "08-NOV-21"
},
{
"NDCCode": "0002-3235-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3235-60) ",
"NDC11Code": "00002-3235-60",
"ProductNDC": "0002-3235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"EndMarketingDate": "20261002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Eli Lilly and Company",
"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": "Deprecated",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040824",
"EndMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "CYMBALTA® is 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": "CYMBALTA® (duloxetine delayed-release capsules) 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 empirical 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, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
"NDCCode": "0002-3240-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3240-30) ",
"NDC11Code": "00002-3240-30",
"ProductNDC": "0002-3240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"EndMarketingDate": "20261002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040824",
"EndMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "CYMBALTA® is 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": "CYMBALTA® (duloxetine delayed-release capsules) 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 empirical 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, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
"NDCCode": "0002-3240-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3240-90) ",
"NDC11Code": "00002-3240-90",
"ProductNDC": "0002-3240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"EndMarketingDate": "20261002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040824",
"EndMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "CYMBALTA® is 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": "CYMBALTA® (duloxetine delayed-release capsules) 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 empirical 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, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
"NDCCode": "0002-3270-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3270-30) ",
"NDC11Code": "00002-3270-30",
"ProductNDC": "0002-3270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100115",
"EndMarketingDate": "20261002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100115",
"EndMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "CYMBALTA® is 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": "CYMBALTA® (duloxetine delayed-release capsules) 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 empirical 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, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
"NDCCode": "0228-2890-06",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2890-06) ",
"NDC11Code": "00228-2890-06",
"ProductNDC": "0228-2890",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090776",
"LabelerName": "Actavis Pharma, 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": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131217",
"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 structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake."
},
{
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"PackageDescription": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2891-03) ",
"NDC11Code": "00228-2891-03",
"ProductNDC": "0228-2891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
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"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090776",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131217",
"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 structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "0228-2891-50",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2891-50) ",
"NDC11Code": "00228-2891-50",
"ProductNDC": "0228-2891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090776",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140905",
"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 structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "0228-2892-03",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-03) ",
"NDC11Code": "00228-2892-03",
"ProductNDC": "0228-2892",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090776",
"LabelerName": "Actavis Pharma, Inc.",
"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": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131217",
"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 structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "0228-2892-96",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-96) ",
"NDC11Code": "00228-2892-96",
"ProductNDC": "0228-2892",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090776",
"LabelerName": "Actavis Pharma, Inc.",
"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": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140905",
"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 structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "0615-8203-05",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-05) ",
"NDC11Code": "00615-8203-05",
"ProductNDC": "0615-8203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190410",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0615-8203-39",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-39) ",
"NDC11Code": "00615-8203-39",
"ProductNDC": "0615-8203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131211",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0615-8204-05",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8204-05) ",
"NDC11Code": "00615-8204-05",
"ProductNDC": "0615-8204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190411",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0615-8204-39",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8204-39) ",
"NDC11Code": "00615-8204-39",
"ProductNDC": "0615-8204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131211",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0615-8290-39",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8290-39) ",
"NDC11Code": "00615-8290-39",
"ProductNDC": "0615-8290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"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": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190610",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
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"StrengthUnit": "mg/1",
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"Description": "Duloxetine delayed-release capsules are 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 USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "0904-7043-61",
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"Description": "Duloxetine delayed-release capsules are 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 USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
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"Description": "Duloxetine delayed-release capsules are 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 USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
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{
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"Description": "Duloxetine delayed-release capsules are 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 USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
}
]
}
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<NDC>
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<PackageDescription>1 BLISTER PACK in 1 CARTON (69230-333-32) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Camber Consumer Care Inc</LabelerName>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>5 BLISTER PACK in 1 CARTON (69230-333-34) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<SamplePackage>N</SamplePackage>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<ProductNDC>69230-318</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<LabelerName>Camber Consumer Care Inc</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage> treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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</NDC>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69230-323-33</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69230-323-33) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>69230-0323-33</NDC11Code>
<ProductNDC>69230-323</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211718</ApplicationNumber>
<LabelerName>Camber Consumer Care Inc</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69230-324-33</NDCCode>
<PackageDescription>10 PACKET in 1 CARTON (69230-324-33) / 17 g in 1 PACKET</PackageDescription>
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<ProductNDC>69230-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350</ProprietaryName>
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<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
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<StartMarketingDate>20210414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214990</ApplicationNumber>
<LabelerName>Camber Consumer Care Inc</LabelerName>
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<StrengthUnit>g/17g</StrengthUnit>
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<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 structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake.</Description>
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<PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-05) </PackageDescription>
<NDC11Code>00615-8203-05</NDC11Code>
<ProductNDC>0615-8203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
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<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190410</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
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<NDC11Code>00615-8203-39</NDC11Code>
<ProductNDC>0615-8203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
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<PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8204-05) </PackageDescription>
<NDC11Code>00615-8204-05</NDC11Code>
<ProductNDC>0615-8204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190411</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
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<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8204-39) </PackageDescription>
<NDC11Code>00615-8204-39</NDC11Code>
<ProductNDC>0615-8204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
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<NDC11Code>00615-8290-39</NDC11Code>
<ProductNDC>0615-8290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190610</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
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<PackageDescription>30 BLISTER PACK in 1 CARTON (0904-7043-04) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7043-04</NDC11Code>
<ProductNDC>0904-7043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090778</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</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>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<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 are 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 USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
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<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7043-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7043-61</NDC11Code>
<ProductNDC>0904-7043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<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 are 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 USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
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<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7044-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7044-61</NDC11Code>
<ProductNDC>0904-7044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Major Pharmaceuticals</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<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 are 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 USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0904-7045-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7045-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7045-61</NDC11Code>
<ProductNDC>0904-7045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090778</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<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 are 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 USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 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 crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
</NDCList>