{
"NDC": [
{
"NDCCode": "66738-304-14",
"PackageDescription": "113 g in 1 TUBE (66738-304-14) ",
"NDC11Code": "66738-0304-14",
"ProductNDC": "66738-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jack Black Sun Guard Sunscreen Spf45",
"NonProprietaryName": "Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Jack Black, LLC",
"SubstanceName": "OCTISALATE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "3; 7.5; 8",
"StrengthUnit": "g/1000g; g/1000g; g/1000g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100209",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "66738-304-27",
"PackageDescription": "44 g in 1 TUBE (66738-304-27) ",
"NDC11Code": "66738-0304-27",
"ProductNDC": "66738-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jack Black Sun Guard Sunscreen Spf45",
"NonProprietaryName": "Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Jack Black, LLC",
"SubstanceName": "OCTISALATE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "3; 7.5; 8",
"StrengthUnit": "g/1000g; g/1000g; g/1000g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130204",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "66738-020-50",
"PackageDescription": "14 g in 1 TUBE (66738-020-50) ",
"NDC11Code": "66738-0020-50",
"ProductNDC": "66738-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Double-duty Face Moisturizer",
"NonProprietaryName": "Mositurizing Sunscreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Jack Black, LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE",
"StrengthNumber": "2.2; 7.5",
"StrengthUnit": "g/1000g; g/1000g",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200311",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "66738-502-21",
"PackageDescription": "14 mL in 1 PACKET (66738-502-21) ",
"NDC11Code": "66738-0502-21",
"ProductNDC": "66738-502",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jack Black",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Jack Black L.L.C",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "3.9; 3.2",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240731",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "10738-304-54",
"PackageDescription": "1 TUBE in 1 BOX (10738-304-54) > 119 g in 1 TUBE (10738-304-14)",
"NDC11Code": "10738-0304-54",
"ProductNDC": "10738-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diabetic Ulcer Defense",
"NonProprietaryName": "Allantoin And Dimethicone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Genuine Virgin Aloe Corporation",
"SubstanceName": "ALLANTOIN; DIMETHICONE",
"StrengthNumber": "1.1; 1.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-05-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54748-304-14",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (54748-304-14) ",
"NDC11Code": "54748-0304-14",
"ProductNDC": "54748-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Everyone Hand Sanitizer",
"ProprietaryNameSuffix": "Ruby Grapefruit",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "EO Products, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251128",
"SamplePackage": "N",
"IndicationAndUsage": " For hand washing to decrease bacteria on skin Recommended for repeated use."
},
{
"NDCCode": "61924-304-14",
"PackageDescription": "14.2 g in 1 PACKET (61924-304-14) ",
"NDC11Code": "61924-0304-14",
"ProductNDC": "61924-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lantiseptic By Dermarite Original Skin Protectant",
"NonProprietaryName": "Lanolin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181225",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Dermarite Industries LLC",
"SubstanceName": "LANOLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181225",
"SamplePackage": "N",
"IndicationAndUsage": "Helps relieve and prevent rashes and irritation due to wetness from incontinence. Protects chafed skin due to irritation and helps seal out wetness."
},
{
"NDCCode": "76413-304-15",
"PackageDescription": "1 TUBE in 1 CARTON (76413-304-15) > 14.17 g in 1 TUBE",
"NDC11Code": "76413-0304-15",
"ProductNDC": "76413-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Major Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20041004",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Central Texas Community Health Centers",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions."
},
{
"NDCCode": "76439-304-14",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (76439-304-14) > 14 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "76439-0304-14",
"ProductNDC": "76439-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Antipyrine And Benzocaine",
"NonProprietaryName": "Antipyrine And Benzocaine",
"DosageFormName": "SOLUTION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20120912",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Virtus Pharmaceuticals",
"SubstanceName": "ANTIPYRINE; BENZOCAINE",
"StrengthNumber": "55; 14",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "0338-0341-04",
"PackageDescription": "14 BAG in 1 CARTON (0338-0341-04) / 1000 mL in 1 BAG",
"NDC11Code": "00338-0341-04",
"ProductNDC": "0338-0341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardioplegic",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRA-ARTERIAL",
"StartMarketingDate": "20000421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075323",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
"StrengthNumber": "17.6; 325.3; 119.3; 643",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000421",
"SamplePackage": "N",
"IndicationAndUsage": "Baxter Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.",
"Description": "Baxter Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in Water for Injection, USP. It is a “core solution” intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains Calcium Chloride Dihydrate USP 17.6 mg, Magnesium Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg and Sodium Chloride USP 643 mg in Water for Injection, USP. May contain HCl and/or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; Magnesium (Mg++) 32 mEq; Potassium (K+) 16 mEq; Sodium (Na+) 110 mEq; Chloride (Cl-) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira1 List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl- 160 mEq and bicarbonate (HCO3-) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "42677-304-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-304-01) ",
"NDC11Code": "42677-0304-01",
"ProductNDC": "42677-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207375",
"LabelerName": "Shandong New Time Pharmaceutical Co., Ltd.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium, USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: mannitol, meglumine, hypromellose, microcrystalline cellulose, crospovidone, magnesium stearate, HPMC 2910/hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin and iron oxide red."
},
{
"NDCCode": "42677-304-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-304-02) ",
"NDC11Code": "42677-0304-02",
"ProductNDC": "42677-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207375",
"LabelerName": "Shandong New Time Pharmaceutical Co., Ltd.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium, USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: mannitol, meglumine, hypromellose, microcrystalline cellulose, crospovidone, magnesium stearate, HPMC 2910/hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin and iron oxide red."
},
{
"NDCCode": "59469-304-10",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-304-10) > 50 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0304-10",
"ProductNDC": "59469-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Co-hypert",
"NonProprietaryName": "Sodium Tetrachloroaurate, Barium Carbonate, Anamirta Cocculus Seed, Iberis Amara Seed, Magnesium Chloride, Ferula Sumbul Root, Melilotus Officinalis Top, And Viscum Album Fruiting Top",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel Gmbh",
"SubstanceName": "SODIUM TETRACHLOROAURATE; BARIUM CARBONATE; ANAMIRTA COCCULUS SEED; IBERIS AMARA SEED; MAGNESIUM CHLORIDE; FERULA SUMBUL ROOT; MELILOTUS OFFICINALIS TOP; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "6; 8; 4; 4; 6; 6; 3; 3",
"StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190624",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional nervous tension. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "63402-304-04",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (63402-304-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-304-07) ",
"NDC11Code": "63402-0304-04",
"ProductNDC": "63402-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Latuda",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101028",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200603",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101028",
"SamplePackage": "N",
"IndicationAndUsage": "LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .",
"Description": "LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "63402-304-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (63402-304-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-304-01) ",
"NDC11Code": "63402-0304-10",
"ProductNDC": "63402-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Latuda",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101028",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200603",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101028",
"SamplePackage": "N",
"IndicationAndUsage": "LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .",
"Description": "LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "63402-304-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63402-304-30) ",
"NDC11Code": "63402-0304-30",
"ProductNDC": "63402-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Latuda",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101028",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200603",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101028",
"SamplePackage": "N",
"IndicationAndUsage": "LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .",
"Description": "LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "63402-304-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (63402-304-50) ",
"NDC11Code": "63402-0304-50",
"ProductNDC": "63402-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Latuda",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101028",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200603",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101028",
"SamplePackage": "N",
"IndicationAndUsage": "LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .",
"Description": "LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "63402-304-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63402-304-90) ",
"NDC11Code": "63402-0304-90",
"ProductNDC": "63402-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Latuda",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101028",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200603",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101028",
"SamplePackage": "N",
"IndicationAndUsage": "LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .",
"Description": "LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "64743-304-01",
"PackageDescription": "200 L in 1 DRUM (64743-304-01) ",
"NDC11Code": "64743-0304-01",
"ProductNDC": "64743-304",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sepia Officinalis Whole",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140822",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Herbamed AG",
"SubstanceName": "SEPIA OFFICINALIS WHOLE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/.001L",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "22-AUG-14"
},
{
"NDCCode": "64764-304-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (64764-304-30) ",
"NDC11Code": "64764-0304-30",
"ProductNDC": "64764-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duetact",
"NonProprietaryName": "Pioglitazone And Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060728",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021925",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE",
"StrengthNumber": "30; 4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Sulfonylurea Compounds [CS], Sulfonylurea [EPC], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060728",
"SamplePackage": "N",
"IndicationAndUsage": "DUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.5)].",
"Description": "DUETACT tablets are a thiazolidinedione and a sulfonylurea combination product that contains two oral antihyperglycemic agents: pioglitazone and glimepiride. The concomitant use of pioglitazone and a sulfonylurea, the class of drugs that includes glimepiride, has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on a sulfonylurea. Additional efficacy and safety information about pioglitazone and glimepiride monotherapies may be found in the prescribing information for each individual drug. Pioglitazone is an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless, white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N‑dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Glimepiride is an oral sulfonylurea chemically identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)-urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. DUETACT is available as a tablet for oral administration containing 30 mg pioglitazone (as the base) with 2 mg glimepiride (30 mg/2 mg) or 30 mg pioglitazone (as the base) with 4 mg glimepiride (30 mg/4 mg) formulated with the following excipients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, hydroxypropyl cellulose NF, polysorbate 80 NF, and microcrystalline cellulose NF."
},
{
"NDCCode": "64764-304-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (64764-304-90) ",
"NDC11Code": "64764-0304-90",
"ProductNDC": "64764-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duetact",
"NonProprietaryName": "Pioglitazone And Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060728",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021925",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE",
"StrengthNumber": "30; 4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Sulfonylurea Compounds [CS], Sulfonylurea [EPC], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060728",
"SamplePackage": "N",
"IndicationAndUsage": "DUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.5)].",
"Description": "DUETACT tablets are a thiazolidinedione and a sulfonylurea combination product that contains two oral antihyperglycemic agents: pioglitazone and glimepiride. The concomitant use of pioglitazone and a sulfonylurea, the class of drugs that includes glimepiride, has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on a sulfonylurea. Additional efficacy and safety information about pioglitazone and glimepiride monotherapies may be found in the prescribing information for each individual drug. Pioglitazone is an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless, white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N‑dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Glimepiride is an oral sulfonylurea chemically identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)-urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. DUETACT is available as a tablet for oral administration containing 30 mg pioglitazone (as the base) with 2 mg glimepiride (30 mg/2 mg) or 30 mg pioglitazone (as the base) with 4 mg glimepiride (30 mg/4 mg) formulated with the following excipients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, hydroxypropyl cellulose NF, polysorbate 80 NF, and microcrystalline cellulose NF."
},
{
"NDCCode": "65757-300-01",
"PackageDescription": "1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03) ",
"NDC11Code": "65757-0300-01",
"ProductNDC": "65757-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivitrol",
"NonProprietaryName": "Naltrexone",
"DosageFormName": "KIT",
"StartMarketingDate": "20060613",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021897",
"LabelerName": "Alkermes, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060613",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.",
"Description": "VIVITROL® (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, to be administered by deep intramuscular injection by a healthcare practitioner. VIVITROL contains naltrexone base anhydrous as the active pharmaceutical ingredient. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity. Naltrexone is morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-(5α) (CAS Registry # 16590-41-3). The molecular formula is C20H23NO4 and its molecular weight is 341.41 in the anhydrous form (ie, < 1% maximum water content). The structural formula is:. Naltrexone base anhydrous is an off-white to a light tan powder with a melting point of 168 °C to 170 °C (334 °F to 338 °F). It is insoluble in water and is soluble in ethanol. VIVITROL is provided in a carton containing one vial of VIVITROL microspheres, one vial of diluent, one 5-mL syringe, one 1-inch 20-gauge preparation needle, two 1 1/2-inch 20-gauge, and two 2-inch 20-gauge administration needles with needle protection device. VIVITROL microspheres consist of a sterile, off-white to light tan powder that is available in a dosage strength of 380 mg of naltrexone per vial. Naltrexone base anhydrous is incorporated in a biodegradable matrix of 75:25 polylactide-co-glycolide (PLG) at a concentration of 337 mg of naltrexone per gram of microspheres. The diluent is a clear to slightly opalescent, colorless to slightly yellow solution. Each mL of diluent contains 5.0 to 35.0 mg of carboxymethylcellulose sodium, 1.0 mg of polysorbate 20, 5.0 to 12.0 mg of sodium chloride, and sodium hydroxide and hydrochloric acid as pH adjusters, in Water for Injection. The pH of the diluent is in the range of 5.8 to 7.2."
},
{
"NDCCode": "69097-341-35",
"PackageDescription": "1 BOTTLE in 1 CARTON (69097-341-35) > 5 mL in 1 BOTTLE",
"NDC11Code": "69097-0341-35",
"ProductNDC": "69097-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Difluprednate",
"NonProprietaryName": "Difluprednate",
"DosageFormName": "EMULSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20210809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211776",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "DIFLUPREDNATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2021-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210809",
"SamplePackage": "N",
"IndicationAndUsage": "Difluprednate ophthalmic emulsion is a topical corticosteroid that is indicated for: 1 The treatment of inflammation and pain associated with ocular surgery (1.1), 2 The treatment of endogenous anterior uveitis (1.2).",
"Description": "Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α,9difluoro-11β,17,21- trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula. Difluprednate has a molecular weight of 508.55, and the empirical formula is C27H34F2O7. Each mL contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%."
},
{
"NDCCode": "70700-165-25",
"PackageDescription": "25 VIAL in 1 CARTON (70700-165-25) / 1 mL in 1 VIAL (70700-165-22) ",
"NDC11Code": "70700-0165-25",
"ProductNDC": "70700-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20200909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212612",
"LabelerName": "Xiromed LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200909",
"SamplePackage": "N",
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"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
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"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
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"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
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"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
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"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
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<IndicationAndUsage> For hand washing to decrease bacteria on skin Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61924-304-14</NDCCode>
<PackageDescription>14.2 g in 1 PACKET (61924-304-14) </PackageDescription>
<NDC11Code>61924-0304-14</NDC11Code>
<ProductNDC>61924-304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lantiseptic By Dermarite Original Skin Protectant</ProprietaryName>
<NonProprietaryName>Lanolin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Dermarite Industries LLC</LabelerName>
<SubstanceName>LANOLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps relieve and prevent rashes and irritation due to wetness from incontinence. Protects chafed skin due to irritation and helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76413-304-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (76413-304-15) > 14.17 g in 1 TUBE</PackageDescription>
<NDC11Code>76413-0304-15</NDC11Code>
<ProductNDC>76413-304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Major Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20041004</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Central Texas Community Health Centers</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76439-304-14</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (76439-304-14) > 14 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>76439-0304-14</NDC11Code>
<ProductNDC>76439-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Antipyrine And Benzocaine</ProprietaryName>
<NonProprietaryName>Antipyrine And Benzocaine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20120912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Virtus Pharmaceuticals</LabelerName>
<SubstanceName>ANTIPYRINE; BENZOCAINE</SubstanceName>
<StrengthNumber>55; 14</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>0338-0341-04</NDCCode>
<PackageDescription>14 BAG in 1 CARTON (0338-0341-04) / 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-0341-04</NDC11Code>
<ProductNDC>0338-0341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardioplegic</ProprietaryName>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL</RouteName>
<StartMarketingDate>20000421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075323</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>17.6; 325.3; 119.3; 643</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baxter Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.</IndicationAndUsage>
<Description>Baxter Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in Water for Injection, USP. It is a “core solution” intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains Calcium Chloride Dihydrate USP 17.6 mg, Magnesium Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg and Sodium Chloride USP 643 mg in Water for Injection, USP. May contain HCl and/or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; Magnesium (Mg++) 32 mEq; Potassium (K+) 16 mEq; Sodium (Na+) 110 mEq; Chloride (Cl-) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira1 List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl- 160 mEq and bicarbonate (HCO3-) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>42677-304-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-304-01) </PackageDescription>
<NDC11Code>42677-0304-01</NDC11Code>
<ProductNDC>42677-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207375</ApplicationNumber>
<LabelerName>Shandong New Time Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium, USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: mannitol, meglumine, hypromellose, microcrystalline cellulose, crospovidone, magnesium stearate, HPMC 2910/hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>42677-304-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-304-02) </PackageDescription>
<NDC11Code>42677-0304-02</NDC11Code>
<ProductNDC>42677-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207375</ApplicationNumber>
<LabelerName>Shandong New Time Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium, USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: mannitol, meglumine, hypromellose, microcrystalline cellulose, crospovidone, magnesium stearate, HPMC 2910/hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>59469-304-10</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-304-10) > 50 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0304-10</NDC11Code>
<ProductNDC>59469-304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Co-hypert</ProprietaryName>
<NonProprietaryName>Sodium Tetrachloroaurate, Barium Carbonate, Anamirta Cocculus Seed, Iberis Amara Seed, Magnesium Chloride, Ferula Sumbul Root, Melilotus Officinalis Top, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel Gmbh</LabelerName>
<SubstanceName>SODIUM TETRACHLOROAURATE; BARIUM CARBONATE; ANAMIRTA COCCULUS SEED; IBERIS AMARA SEED; MAGNESIUM CHLORIDE; FERULA SUMBUL ROOT; MELILOTUS OFFICINALIS TOP; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>6; 8; 4; 4; 6; 6; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional nervous tension. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63402-304-04</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (63402-304-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-304-07) </PackageDescription>
<NDC11Code>63402-0304-04</NDC11Code>
<ProductNDC>63402-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Latuda</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101028</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200603</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>63402-304-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (63402-304-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-304-01) </PackageDescription>
<NDC11Code>63402-0304-10</NDC11Code>
<ProductNDC>63402-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Latuda</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101028</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200603</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>63402-304-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63402-304-30) </PackageDescription>
<NDC11Code>63402-0304-30</NDC11Code>
<ProductNDC>63402-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Latuda</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101028</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200603</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>63402-304-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (63402-304-50) </PackageDescription>
<NDC11Code>63402-0304-50</NDC11Code>
<ProductNDC>63402-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Latuda</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101028</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200603</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>63402-304-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63402-304-90) </PackageDescription>
<NDC11Code>63402-0304-90</NDC11Code>
<ProductNDC>63402-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Latuda</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101028</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200603</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>64743-304-01</NDCCode>
<PackageDescription>200 L in 1 DRUM (64743-304-01) </PackageDescription>
<NDC11Code>64743-0304-01</NDC11Code>
<ProductNDC>64743-304</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sepia Officinalis Whole</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140822</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Herbamed AG</LabelerName>
<SubstanceName>SEPIA OFFICINALIS WHOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/.001L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-AUG-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64764-304-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64764-304-30) </PackageDescription>
<NDC11Code>64764-0304-30</NDC11Code>
<ProductNDC>64764-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duetact</ProprietaryName>
<NonProprietaryName>Pioglitazone And Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060728</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021925</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE</SubstanceName>
<StrengthNumber>30; 4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Sulfonylurea Compounds [CS], Sulfonylurea [EPC], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.5)].</IndicationAndUsage>
<Description>DUETACT tablets are a thiazolidinedione and a sulfonylurea combination product that contains two oral antihyperglycemic agents: pioglitazone and glimepiride. The concomitant use of pioglitazone and a sulfonylurea, the class of drugs that includes glimepiride, has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on a sulfonylurea. Additional efficacy and safety information about pioglitazone and glimepiride monotherapies may be found in the prescribing information for each individual drug. Pioglitazone is an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless, white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N‑dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Glimepiride is an oral sulfonylurea chemically identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)-urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. DUETACT is available as a tablet for oral administration containing 30 mg pioglitazone (as the base) with 2 mg glimepiride (30 mg/2 mg) or 30 mg pioglitazone (as the base) with 4 mg glimepiride (30 mg/4 mg) formulated with the following excipients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, hydroxypropyl cellulose NF, polysorbate 80 NF, and microcrystalline cellulose NF.</Description>
</NDC>
<NDC>
<NDCCode>64764-304-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (64764-304-90) </PackageDescription>
<NDC11Code>64764-0304-90</NDC11Code>
<ProductNDC>64764-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duetact</ProprietaryName>
<NonProprietaryName>Pioglitazone And Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060728</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021925</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE</SubstanceName>
<StrengthNumber>30; 4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Sulfonylurea Compounds [CS], Sulfonylurea [EPC], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.5)].</IndicationAndUsage>
<Description>DUETACT tablets are a thiazolidinedione and a sulfonylurea combination product that contains two oral antihyperglycemic agents: pioglitazone and glimepiride. The concomitant use of pioglitazone and a sulfonylurea, the class of drugs that includes glimepiride, has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on a sulfonylurea. Additional efficacy and safety information about pioglitazone and glimepiride monotherapies may be found in the prescribing information for each individual drug. Pioglitazone is an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless, white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N‑dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Glimepiride is an oral sulfonylurea chemically identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)-urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. DUETACT is available as a tablet for oral administration containing 30 mg pioglitazone (as the base) with 2 mg glimepiride (30 mg/2 mg) or 30 mg pioglitazone (as the base) with 4 mg glimepiride (30 mg/4 mg) formulated with the following excipients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, hydroxypropyl cellulose NF, polysorbate 80 NF, and microcrystalline cellulose NF.</Description>
</NDC>
<NDC>
<NDCCode>65757-300-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03) </PackageDescription>
<NDC11Code>65757-0300-01</NDC11Code>
<ProductNDC>65757-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vivitrol</ProprietaryName>
<NonProprietaryName>Naltrexone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060613</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021897</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.</IndicationAndUsage>
<Description>VIVITROL® (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, to be administered by deep intramuscular injection by a healthcare practitioner. VIVITROL contains naltrexone base anhydrous as the active pharmaceutical ingredient. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity. Naltrexone is morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-(5α) (CAS Registry # 16590-41-3). The molecular formula is C20H23NO4 and its molecular weight is 341.41 in the anhydrous form (ie, < 1% maximum water content). The structural formula is:. Naltrexone base anhydrous is an off-white to a light tan powder with a melting point of 168 °C to 170 °C (334 °F to 338 °F). It is insoluble in water and is soluble in ethanol. VIVITROL is provided in a carton containing one vial of VIVITROL microspheres, one vial of diluent, one 5-mL syringe, one 1-inch 20-gauge preparation needle, two 1 1/2-inch 20-gauge, and two 2-inch 20-gauge administration needles with needle protection device. VIVITROL microspheres consist of a sterile, off-white to light tan powder that is available in a dosage strength of 380 mg of naltrexone per vial. Naltrexone base anhydrous is incorporated in a biodegradable matrix of 75:25 polylactide-co-glycolide (PLG) at a concentration of 337 mg of naltrexone per gram of microspheres. The diluent is a clear to slightly opalescent, colorless to slightly yellow solution. Each mL of diluent contains 5.0 to 35.0 mg of carboxymethylcellulose sodium, 1.0 mg of polysorbate 20, 5.0 to 12.0 mg of sodium chloride, and sodium hydroxide and hydrochloric acid as pH adjusters, in Water for Injection. The pH of the diluent is in the range of 5.8 to 7.2.</Description>
</NDC>
<NDC>
<NDCCode>69097-341-35</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69097-341-35) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69097-0341-35</NDC11Code>
<ProductNDC>69097-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Difluprednate</ProprietaryName>
<NonProprietaryName>Difluprednate</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20210809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211776</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>DIFLUPREDNATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Difluprednate ophthalmic emulsion is a topical corticosteroid that is indicated for: 1 The treatment of inflammation and pain associated with ocular surgery (1.1), 2 The treatment of endogenous anterior uveitis (1.2).</IndicationAndUsage>
<Description>Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α,9difluoro-11β,17,21- trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula. Difluprednate has a molecular weight of 508.55, and the empirical formula is C27H34F2O7. Each mL contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%.</Description>
</NDC>
<NDC>
<NDCCode>70700-165-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70700-165-25) / 1 mL in 1 VIAL (70700-165-22) </PackageDescription>
<NDC11Code>70700-0165-25</NDC11Code>
<ProductNDC>70700-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20200909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212612</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In AnesthesiaGlycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.In Peptic UlcerFor use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>70700-166-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70700-166-25) / 2 mL in 1 VIAL (70700-166-22) </PackageDescription>
<NDC11Code>70700-0166-25</NDC11Code>
<ProductNDC>70700-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20200909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212612</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>In AnesthesiaGlycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.In Peptic UlcerFor use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
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<NDCCode>70700-167-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70700-167-25) / 5 mL in 1 VIAL (70700-167-22) </PackageDescription>
<NDC11Code>70700-0167-25</NDC11Code>
<ProductNDC>70700-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20200909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212612</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
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<IndicationAndUsage>In AnesthesiaGlycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.In Peptic UlcerFor use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>70700-168-23</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70700-168-23) / 20 mL in 1 VIAL (70700-168-22) </PackageDescription>
<NDC11Code>70700-0168-23</NDC11Code>
<ProductNDC>70700-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
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<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20200909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212612</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>In AnesthesiaGlycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.In Peptic UlcerFor use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>70700-902-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70700-902-25) / 5 mL in 1 VIAL (70700-902-22) </PackageDescription>
<NDC11Code>70700-0902-25</NDC11Code>
<ProductNDC>70700-902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20211109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212612</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In AnesthesiaGlycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.In Peptic UlcerFor use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>70700-903-23</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70700-903-23) / 20 mL in 1 VIAL (70700-903-22) </PackageDescription>
<NDC11Code>70700-0903-23</NDC11Code>
<ProductNDC>70700-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20211109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212612</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In AnesthesiaGlycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.In Peptic UlcerFor use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP................0.2 mgWater for Injection, USP..........q.s.Benzyl Alcohol, NF...................0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.For Intramuscular (IM) or Intravenous (IV) administration.Glycopyrrolate is a quaternary ammonium salt with the following chemical name:3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
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<NDC>
<NDCCode>71409-304-80</NDCCode>
<PackageDescription>80 PELLET in 1 VIAL, DISPENSING (71409-304-80) </PackageDescription>
<NDC11Code>71409-0304-80</NDC11Code>
<ProductNDC>71409-304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Cold And Flu Relief</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20170714</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Clineva Management Services, LLC</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ALLIUM CEPA WHOLE; ARNICA MONTANA; EUPATORIUM CANNABINUM WHOLE; GELSEMIUM SEMPERVIRENS ROOT; SOLANUM DULCAMARA WHOLE</SubstanceName>
<StrengthNumber>14; 8; 8; 8; 18; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: For the temporary relief of minor fever, chills, runny nose, congestion, body aches and fatigue due to the common cold or the flu.</IndicationAndUsage>
</NDC>
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