{
"NDC": [
{
"NDCCode": "49483-145-40",
"PackageDescription": "400 CAPSULE in 1 BOTTLE (49483-145-40) ",
"NDC11Code": "49483-0145-40",
"ProductNDC": "49483-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Psyllium Husk",
"ProprietaryNameSuffix": "Fiber Supplement",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "TIME CAP LABS INC",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": ".52",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "effective in treating occasional constipation and restoring regularity. This product generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "49483-145-20",
"PackageDescription": "200 CAPSULE in 1 BOTTLE (49483-145-20) ",
"NDC11Code": "49483-0145-20",
"ProductNDC": "49483-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Psyllium Husk",
"ProprietaryNameSuffix": "Fiber Supplement",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "TIME CAP LABS INC",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": ".52",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "effective in treating occasional constipation and restoring regularity. This product generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "49483-343-44",
"PackageDescription": "40 TABLET, FILM COATED in 1 BOTTLE (49483-343-44) ",
"NDC11Code": "49483-0343-44",
"ProductNDC": "49483-343",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alert",
"NonProprietaryName": "Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111130",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part340",
"LabelerName": "Time Cap Labs, Inc",
"SubstanceName": "CAFFEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181217",
"SamplePackage": "N"
},
{
"NDCCode": "49483-430-40",
"PackageDescription": "400 TABLET in 1 BOTTLE (49483-430-40) ",
"NDC11Code": "49483-0430-40",
"ProductNDC": "49483-430",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Acetaminophen Pm",
"NonProprietaryName": "Acetaminophen 500mg/ Diphenhydramine Hcl 25mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "TIME CAP LABS INC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "25; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230722",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
},
{
"NDCCode": "49483-610-44",
"PackageDescription": "40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49483-610-44) ",
"NDC11Code": "49483-0610-44",
"ProductNDC": "49483-610",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20151223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079205",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151223",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. temporarily relieves minor aches and pains due to: 1 headache, 2 toothache, 3 backache, 4 menstrual cramps, 5 the common cold, 6 muscular aches, 7 minor pain of arthritis."
},
{
"NDCCode": "49483-699-40",
"PackageDescription": "400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40) ",
"NDC11Code": "49483-0699-40",
"ProductNDC": "49483-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen Tablet Extended Release",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211004",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache."
},
{
"NDCCode": "49483-720-40",
"PackageDescription": "400 TABLET in 1 BOTTLE (49483-720-40) ",
"NDC11Code": "49483-0720-40",
"ProductNDC": "49483-720",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Acid Reducer",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217543",
"LabelerName": "TIME CAP LABORATORIES,INC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231118",
"SamplePackage": "N"
},
{
"NDCCode": "10424-145-40",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (10424-145-40) > 90 TABLET in 1 BLISTER PACK",
"NDC11Code": "10424-0145-40",
"ProductNDC": "10424-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Syreflux",
"NonProprietaryName": "Penicillium Roqueforti",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110121",
"EndMarketingDate": "20160131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Syntrion GmbH",
"SubstanceName": "PENICILLIUM ROQUEFORTI",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2016-02-05"
},
{
"NDCCode": "20276-145-40",
"PackageDescription": "1180 mL in 1 BOTTLE, PLASTIC (20276-145-40) ",
"NDC11Code": "20276-0145-40",
"ProductNDC": "20276-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lucky",
"ProprietaryNameSuffix": "Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Delta Brands, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201104",
"SamplePackage": "N",
"IndicationAndUsage": "for hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "49404-145-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (49404-145-02) / 40 mL in 1 CONTAINER",
"NDC11Code": "49404-0145-02",
"ProductNDC": "49404-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr.jart Dis-a-pore Beauty Balm 01",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191107",
"EndMarketingDate": "20250110",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Have & Be Co., Ltd.",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.996; 1.2; 6.388",
"StrengthUnit": "mg/40mL; mg/40mL; mg/40mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191107",
"EndMarketingDatePackage": "20250110",
"SamplePackage": "N"
},
{
"NDCCode": "55700-145-40",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (55700-145-40) ",
"NDC11Code": "55700-0145-40",
"ProductNDC": "55700-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065253",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N"
},
{
"NDCCode": "84025-145-01",
"PackageDescription": "40 g in 1 BOTTLE (84025-145-01) ",
"NDC11Code": "84025-0145-01",
"ProductNDC": "84025-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Faciallotion",
"NonProprietaryName": "Facial Lotion",
"DosageFormName": "LOTION",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20240814",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Guangzhou Yanxi Biotechnology Co.. Ltd",
"SubstanceName": "GLYCERIN; HYALURONIC ACID",
"StrengthNumber": "3; 5",
"StrengthUnit": "mg/50g; mg/50g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240814",
"SamplePackage": "N",
"IndicationAndUsage": "For daily skin care."
},
{
"NDCCode": "49483-221-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-06) ",
"NDC11Code": "49483-0221-06",
"ProductNDC": "49483-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "49483-221-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-10) ",
"NDC11Code": "49483-0221-10",
"ProductNDC": "49483-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "49483-222-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (49483-222-06) ",
"NDC11Code": "49483-0222-06",
"ProductNDC": "49483-222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "6.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "49483-222-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (49483-222-10) ",
"NDC11Code": "49483-0222-10",
"ProductNDC": "49483-222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "6.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "49483-223-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (49483-223-06) ",
"NDC11Code": "49483-0223-06",
"ProductNDC": "49483-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "49483-223-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (49483-223-10) ",
"NDC11Code": "49483-0223-10",
"ProductNDC": "49483-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "49483-701-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (49483-701-01) ",
"NDC11Code": "49483-0701-01",
"ProductNDC": "49483-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "49483-701-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (49483-701-10) ",
"NDC11Code": "49483-0701-10",
"ProductNDC": "49483-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "49483-702-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (49483-702-01) ",
"NDC11Code": "49483-0702-01",
"ProductNDC": "49483-702",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "49483-702-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (49483-702-10) ",
"NDC11Code": "49483-0702-10",
"ProductNDC": "49483-702",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "49483-703-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (49483-703-01) ",
"NDC11Code": "49483-0703-01",
"ProductNDC": "49483-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "49483-703-03",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (49483-703-03) ",
"NDC11Code": "49483-0703-03",
"ProductNDC": "49483-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "49483-703-50",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (49483-703-50) ",
"NDC11Code": "49483-0703-50",
"ProductNDC": "49483-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220212",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "0002-7772-11",
"PackageDescription": "1 SYRINGE in 1 CARTON (0002-7772-11) / 2 mL in 1 SYRINGE (0002-7772-01) ",
"NDC11Code": "00002-7772-11",
"ProductNDC": "0002-7772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebglyss",
"NonProprietaryName": "Lebrikizumab-lbkz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240913",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761306",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "LEBRIKIZUMAB",
"StrengthNumber": "250",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240913",
"SamplePackage": "N",
"IndicationAndUsage": "EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.",
"Description": "Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0."
},
{
"NDCCode": "0002-7772-62",
"PackageDescription": "2 SYRINGE in 1 CARTON (0002-7772-62) / 2 mL in 1 SYRINGE",
"NDC11Code": "00002-7772-62",
"ProductNDC": "0002-7772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebglyss",
"NonProprietaryName": "Lebrikizumab-lbkz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240913",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761306",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "LEBRIKIZUMAB",
"StrengthNumber": "250",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240913",
"SamplePackage": "Y",
"IndicationAndUsage": "EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.",
"Description": "Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0."
},
{
"NDCCode": "0002-7797-11",
"PackageDescription": "1 SYRINGE in 1 CARTON (0002-7797-11) / 2 mL in 1 SYRINGE (0002-7797-01) ",
"NDC11Code": "00002-7797-11",
"ProductNDC": "0002-7797",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebglyss",
"NonProprietaryName": "Lebrikizumab-lbkz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240913",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761306",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "LEBRIKIZUMAB",
"StrengthNumber": "250",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240913",
"SamplePackage": "N",
"IndicationAndUsage": "EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.",
"Description": "Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0."
},
{
"NDCCode": "0002-7797-61",
"PackageDescription": "1 SYRINGE in 1 CARTON (0002-7797-61) / 2 mL in 1 SYRINGE",
"NDC11Code": "00002-7797-61",
"ProductNDC": "0002-7797",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebglyss",
"NonProprietaryName": "Lebrikizumab-lbkz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240913",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761306",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "LEBRIKIZUMAB",
"StrengthNumber": "250",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240913",
"SamplePackage": "Y",
"IndicationAndUsage": "EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.",
"Description": "Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0."
},
{
"NDCCode": "16110-035-12",
"PackageDescription": "1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE",
"NDC11Code": "16110-0035-12",
"ProductNDC": "16110-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cordran",
"NonProprietaryName": "Flurandrenolide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19651018",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012806",
"LabelerName": "Almirall, LLC",
"SubstanceName": "FLURANDRENOLIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19651018",
"SamplePackage": "N",
"IndicationAndUsage": "Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
}
]
}
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<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<NDC>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>TIME CAP LABS INC</LabelerName>
<SubstanceName>PSYLLIUM HUSK</SubstanceName>
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<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
<NDCCode>49483-343-44</NDCCode>
<PackageDescription>40 TABLET, FILM COATED in 1 BOTTLE (49483-343-44) </PackageDescription>
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<ProductNDC>49483-343</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alert</ProprietaryName>
<NonProprietaryName>Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part340</ApplicationNumber>
<LabelerName>Time Cap Labs, Inc</LabelerName>
<SubstanceName>CAFFEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49483-430-40</NDCCode>
<PackageDescription>400 TABLET in 1 BOTTLE (49483-430-40) </PackageDescription>
<NDC11Code>49483-0430-40</NDC11Code>
<ProductNDC>49483-430</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Acetaminophen Pm</ProprietaryName>
<NonProprietaryName>Acetaminophen 500mg/ Diphenhydramine Hcl 25mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>TIME CAP LABS INC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>25; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-610-44</NDCCode>
<PackageDescription>40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49483-610-44) </PackageDescription>
<NDC11Code>49483-0610-44</NDC11Code>
<ProductNDC>49483-610</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079205</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. temporarily relieves minor aches and pains due to: 1 headache, 2 toothache, 3 backache, 4 menstrual cramps, 5 the common cold, 6 muscular aches, 7 minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-699-40</NDCCode>
<PackageDescription>400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40) </PackageDescription>
<NDC11Code>49483-0699-40</NDC11Code>
<ProductNDC>49483-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablet Extended Release</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215486</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-720-40</NDCCode>
<PackageDescription>400 TABLET in 1 BOTTLE (49483-720-40) </PackageDescription>
<NDC11Code>49483-0720-40</NDC11Code>
<ProductNDC>49483-720</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Strength Acid Reducer</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217543</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES,INC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10424-145-40</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (10424-145-40) > 90 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>10424-0145-40</NDC11Code>
<ProductNDC>10424-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Syreflux</ProprietaryName>
<NonProprietaryName>Penicillium Roqueforti</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110121</StartMarketingDate>
<EndMarketingDate>20160131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Syntrion GmbH</LabelerName>
<SubstanceName>PENICILLIUM ROQUEFORTI</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>20276-145-40</NDCCode>
<PackageDescription>1180 mL in 1 BOTTLE, PLASTIC (20276-145-40) </PackageDescription>
<NDC11Code>20276-0145-40</NDC11Code>
<ProductNDC>20276-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lucky</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Delta Brands, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49404-145-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (49404-145-02) / 40 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>49404-0145-02</NDC11Code>
<ProductNDC>49404-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr.jart Dis-a-pore Beauty Balm 01</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191107</StartMarketingDate>
<EndMarketingDate>20250110</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Have & Be Co., Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.996; 1.2; 6.388</StrengthNumber>
<StrengthUnit>mg/40mL; mg/40mL; mg/40mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191107</StartMarketingDatePackage>
<EndMarketingDatePackage>20250110</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-145-40</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (55700-145-40) </PackageDescription>
<NDC11Code>55700-0145-40</NDC11Code>
<ProductNDC>55700-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065253</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84025-145-01</NDCCode>
<PackageDescription>40 g in 1 BOTTLE (84025-145-01) </PackageDescription>
<NDC11Code>84025-0145-01</NDC11Code>
<ProductNDC>84025-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Faciallotion</ProprietaryName>
<NonProprietaryName>Facial Lotion</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20240814</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Guangzhou Yanxi Biotechnology Co.. Ltd</LabelerName>
<SubstanceName>GLYCERIN; HYALURONIC ACID</SubstanceName>
<StrengthNumber>3; 5</StrengthNumber>
<StrengthUnit>mg/50g; mg/50g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For daily skin care.</IndicationAndUsage>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
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<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>6.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
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<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
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<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide.</Description>
</NDC>
<NDC>
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<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
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<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-702-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (49483-702-10) </PackageDescription>
<NDC11Code>49483-0702-10</NDC11Code>
<ProductNDC>49483-702</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075465</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-703-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (49483-703-01) </PackageDescription>
<NDC11Code>49483-0703-01</NDC11Code>
<ProductNDC>49483-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075465</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-703-03</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (49483-703-03) </PackageDescription>
<NDC11Code>49483-0703-03</NDC11Code>
<ProductNDC>49483-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075465</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>49483-703-50</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (49483-703-50) </PackageDescription>
<NDC11Code>49483-0703-50</NDC11Code>
<ProductNDC>49483-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075465</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)]. Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0002-7772-11</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-7772-11) / 2 mL in 1 SYRINGE (0002-7772-01) </PackageDescription>
<NDC11Code>00002-7772-11</NDC11Code>
<ProductNDC>0002-7772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebglyss</ProprietaryName>
<NonProprietaryName>Lebrikizumab-lbkz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240913</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761306</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>LEBRIKIZUMAB</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.</IndicationAndUsage>
<Description>Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0002-7772-62</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0002-7772-62) / 2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-7772-62</NDC11Code>
<ProductNDC>0002-7772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebglyss</ProprietaryName>
<NonProprietaryName>Lebrikizumab-lbkz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240913</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761306</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>LEBRIKIZUMAB</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240913</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.</IndicationAndUsage>
<Description>Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0002-7797-11</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-7797-11) / 2 mL in 1 SYRINGE (0002-7797-01) </PackageDescription>
<NDC11Code>00002-7797-11</NDC11Code>
<ProductNDC>0002-7797</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebglyss</ProprietaryName>
<NonProprietaryName>Lebrikizumab-lbkz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240913</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761306</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>LEBRIKIZUMAB</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.</IndicationAndUsage>
<Description>Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0002-7797-61</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-7797-61) / 2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-7797-61</NDC11Code>
<ProductNDC>0002-7797</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebglyss</ProprietaryName>
<NonProprietaryName>Lebrikizumab-lbkz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240913</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761306</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>LEBRIKIZUMAB</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240913</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.</IndicationAndUsage>
<Description>Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0.</Description>
</NDC>
<NDC>
<NDCCode>16110-035-12</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE</PackageDescription>
<NDC11Code>16110-0035-12</NDC11Code>
<ProductNDC>16110-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cordran</ProprietaryName>
<NonProprietaryName>Flurandrenolide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19651018</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012806</ApplicationNumber>
<LabelerName>Almirall, LLC</LabelerName>
<SubstanceName>FLURANDRENOLIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19651018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
</NDCList>