{
"NDC": [
{
"NDCCode": "71205-192-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-192-60) ",
"NDC11Code": "71205-0192-60",
"ProductNDC": "71205-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078103",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "71205-192-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71205-192-30) ",
"NDC11Code": "71205-0192-30",
"ProductNDC": "71205-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078103",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "71205-192-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71205-192-90) ",
"NDC11Code": "71205-0192-90",
"ProductNDC": "71205-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078103",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "10544-192-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (10544-192-60)",
"NDC11Code": "10544-0192-60",
"ProductNDC": "10544-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074223",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with non-insulin-dependent diabetes mellitus (NIDDM; type II), formerly known as maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory. In initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified, and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of glipizide must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone also may be transient, thus requiring only short-term administration of glipizide. During maintenance programs, glipizide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgements should be based on regular clinical and laboratory evaluations. In considering the use of glipizide in asymptomatic patients, it should be recognized that controlling the blood glucose in non-insulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-Cyclohexyl-3-[[ p-[2-(5-methylpyrazinecarboxamido)-ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.54; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch and stearic acid."
},
{
"NDCCode": "13734-192-60",
"PackageDescription": "1 TUBE in 1 BOX (13734-192-60) / 50 mL in 1 TUBE",
"NDC11Code": "13734-0192-60",
"ProductNDC": "13734-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nars Pure Radiant Tinted Moisturizer",
"ProprietaryNameSuffix": "Granada",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "NARS Cosmetics",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "4.044; 3.996",
"StrengthUnit": "g/50mL; g/50mL",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251217",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunbun. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "41226-192-06",
"PackageDescription": "60 TABLET, COATED in 1 BOTTLE (41226-192-06) ",
"NDC11Code": "41226-0192-06",
"ProductNDC": "41226-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna-s",
"NonProprietaryName": "Docusate Sodium And Sennosides",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "KROGER",
"SubstanceName": "SENNOSIDES; DOCUSATE SODIUM",
"StrengthNumber": "8.6; 50",
"StrengthUnit": "mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Relieves occasional constipation (irregularity), 2 generally causes bowel movement in 6-12 hours."
},
{
"NDCCode": "42291-192-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42291-192-60) ",
"NDC11Code": "42291-0192-60",
"ProductNDC": "42291-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076898",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20141210",
"SamplePackage": "N"
},
{
"NDCCode": "42507-192-07",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (42507-192-07) / 60 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "42507-0192-07",
"ProductNDC": "42507-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211075",
"LabelerName": "HYVEE INC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "43744-192-60",
"PackageDescription": "750 g in 1 DRUM (43744-192-60)",
"NDC11Code": "43744-0192-60",
"ProductNDC": "43744-192",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cidofovir Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120404",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "CIDOFOVIR",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "46122-192-60",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-192-60) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "46122-0192-60",
"ProductNDC": "46122-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Mucus Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130624",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130624",
"SamplePackage": "N"
},
{
"NDCCode": "50228-192-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50228-192-60) ",
"NDC11Code": "50228-0192-60",
"ProductNDC": "50228-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205237",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220318",
"SamplePackage": "N",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile, soluble in dichloromethane and methanol."
},
{
"NDCCode": "51991-192-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (51991-192-06) ",
"NDC11Code": "51991-0192-06",
"ProductNDC": "51991-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methscopolamine Bromide",
"NonProprietaryName": "Methscopolamine Bromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040642",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "METHSCOPOLAMINE BROMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120521",
"SamplePackage": "N",
"IndicationAndUsage": "Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.",
"Description": "Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg contain methscopolamine bromide, USP, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform. The chemical name for methscopolamine bromide is 3-Oxa-9-azoniatricyclo [3.3.1.02,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(S)-(1α, 2β, 4β, 5α, 7β)]-and the molecular weight is 398.30. The structural formula is represented below. Methscopolamine Bromide Tablets, USP 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide, USP. Methscopolamine Bromide Tablets, USP 5 mg for oral administration contain 5 mg of methscopolamine bromide, USP."
},
{
"NDCCode": "51991-192-60",
"PackageDescription": "5 BLISTER PACK in 1 BOX (51991-192-60) / 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "51991-0192-60",
"ProductNDC": "51991-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methscopolamine Bromide",
"NonProprietaryName": "Methscopolamine Bromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040642",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "METHSCOPOLAMINE BROMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120521",
"SamplePackage": "N",
"IndicationAndUsage": "Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.",
"Description": "Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg contain methscopolamine bromide, USP, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform. The chemical name for methscopolamine bromide is 3-Oxa-9-azoniatricyclo [3.3.1.02,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(S)-(1α, 2β, 4β, 5α, 7β)]-and the molecular weight is 398.30. The structural formula is represented below. Methscopolamine Bromide Tablets, USP 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide, USP. Methscopolamine Bromide Tablets, USP 5 mg for oral administration contain 5 mg of methscopolamine bromide, USP."
},
{
"NDCCode": "52685-192-60",
"PackageDescription": "1 TUBE in 1 CARTON (52685-192-60) > 40 g in 1 TUBE",
"NDC11Code": "52685-0192-60",
"ProductNDC": "52685-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Smoothing Base For Lines",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "3960",
"StrengthUnit": "mg/40g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "53217-192-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (53217-192-60)",
"NDC11Code": "53217-0192-60",
"ProductNDC": "53217-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040148",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in a variety of strengths as described in the following table. HydrocodoneStrength Bitartrate Acetaminophen. 2.5 mg/325 mg 2.5 mg 325 mg 5 mg/325 mg 5 mg 325 mg. 7.5 mg/325 mg 7.5 mg 325 mg. 10 mg/325 mg 10 mg 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium and magnesium stearate. Meets USP Dissolution Test 1."
},
{
"NDCCode": "55700-192-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-192-60) ",
"NDC11Code": "55700-0192-60",
"ProductNDC": "55700-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20141212",
"SamplePackage": "N",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol 6000, prosolv, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "61442-192-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (61442-192-60) ",
"NDC11Code": "61442-0192-60",
"ProductNDC": "61442-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212947",
"LabelerName": "Carlsbad Technology, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250622",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine Hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, and Triacetin."
},
{
"NDCCode": "61919-192-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-192-60) ",
"NDC11Code": "61919-0192-60",
"ProductNDC": "61919-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203126",
"LabelerName": "DIRECT RX",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170718",
"SamplePackage": "N",
"IndicationAndUsage": "I. Vasospastic Angina. Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers. II. Chronic Stable Angina. (Classical Effort-Associated Angina). Nifedipine extended-release tablets are indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina), nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely, since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS). III. Hypertension. Nifedipine extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including nifedipine extended-release tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nifedipine extended-release tablets may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17H 18N 2O 6, and has the structural formula. [image description]. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine GITS (Gastrointestinal Therapeutic System) tablet is formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: cellulose acetate; ferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; potassium chloride; povidone; sodium chloride; titanium dioxide; propylene glycol and black iron oxide. The USP Dissolution Test is pending. System Components and Performance. Nifedipine extended-release tablets are similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, releasing drug through the precision laser-drilled tablet orifice in the active layer. Nifedipine extended-release tablets are designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. Nifedipine extended-release tablets depend for its action on the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the gastrointestinal tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell."
},
{
"NDCCode": "63187-192-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (63187-192-60) ",
"NDC11Code": "63187-0192-60",
"ProductNDC": "63187-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077309",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir tablet is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablet is a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula."
},
{
"NDCCode": "71610-192-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71610-192-60) ",
"NDC11Code": "71610-0192-60",
"ProductNDC": "71610-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078413",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2019-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181108",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem tartrate USP is a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate USP is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3."
},
{
"NDCCode": "72789-192-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-192-60) ",
"NDC11Code": "72789-0192-60",
"ProductNDC": "72789-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hcl",
"NonProprietaryName": "Metformin Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090564",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210817",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol."
},
{
"NDCCode": "74913-192-01",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (74913-192-01) ",
"NDC11Code": "74913-0192-01",
"ProductNDC": "74913-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200408",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75329-2011-8",
"PackageDescription": "192 BOTTLE, PUMP in 1 BOX (75329-2011-8) > 60 mL in 1 BOTTLE, PUMP (75329-2011-1) ",
"NDC11Code": "75329-2011-08",
"ProductNDC": "75329-2011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200619",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Ningbo Lizi Commodity Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "45",
"StrengthUnit": "mL/60mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200619",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "76177-192-60",
"PackageDescription": "60 g in 1 BAG (76177-192-60) ",
"NDC11Code": "76177-0192-60",
"ProductNDC": "76177-192",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230110",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sinopep-Allsino Biopharmaceutical Co., Ltd.",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-05-12",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "10-JAN-23"
},
{
"NDCCode": "83209-192-60",
"PackageDescription": "60 CAPSULE in 1 BLISTER PACK (83209-192-60) ",
"NDC11Code": "83209-0192-60",
"ProductNDC": "83209-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240816",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "85766-192-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (85766-192-60) ",
"NDC11Code": "85766-0192-60",
"ProductNDC": "85766-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium/misoprostol",
"ProprietaryNameSuffix": "Diclofenac-sodium-misoprostol",
"NonProprietaryName": "Diclofenac Sodium/misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204355",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "75; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260324",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 69.58 mg of diclofenac) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "86937-005-02",
"PackageDescription": "60 PACKAGE in 1 PACKET (86937-005-02) > 3.192 g in 1 PACKAGE",
"NDC11Code": "86937-0005-02",
"ProductNDC": "86937-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fresh N Soft Antibacterial Wet Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201223",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201223",
"SamplePackage": "N",
"IndicationAndUsage": "Decreases bacteria on the skin that could cause disease."
},
{
"NDCCode": "87063-192-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (87063-192-60) ",
"NDC11Code": "87063-0192-60",
"ProductNDC": "87063-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091491",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (green), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. 500 mg tablets: D&C Yellow #10/aluminum lake and FD&C Blue #1/brilliant blue FCF aluminum lake. 750 mg tablets: FD&C Red #40/alura red AC aluminum lake, FD&C Yellow #6/sunset yellow FCF aluminum lake, and FD&C Blue #1/brilliant blue FCF aluminum lake. Meets USP Dissolution Test 3."
},
{
"NDCCode": "10812-192-01",
"PackageDescription": "141 g in 1 CAN (10812-192-01)",
"NDC11Code": "10812-0192-01",
"ProductNDC": "10812-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Fresh Cooling Sunscreen",
"ProprietaryNameSuffix": "Body Mist Broad Spectrum Spf45",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121018",
"EndMarketingDate": "20180805",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 150; 50; 23.5; 60",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-08-06",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "55150-192-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-192-01) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0192-01",
"ProductNDC": "55150-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adenosine",
"NonProprietaryName": "Adenosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20171102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205331",
"LabelerName": "Eugia US LLC",
"SubstanceName": "ADENOSINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171102",
"SamplePackage": "N",
"IndicationAndUsage": "Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.",
"Description": "Adenosine is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenosine has the following structural formula: The molecular formula for adenosine is C10H13N5O4 and its molecular weight is 267.24. Adenosine USP is a white or almost white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH of the solution. Each adenosine injection, USP vial contains a sterile, non-pyrogenic, clear colorless solution of adenosine USP 3 mg/mL and sodium chloride 9 mg/mL in water for injection, with pH between 4.5 and 7.5."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>71205-192-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-192-60) </PackageDescription>
<NDC11Code>71205-0192-60</NDC11Code>
<ProductNDC>71205-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078103</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SIMVASTATIN</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>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>71205-192-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71205-192-30) </PackageDescription>
<NDC11Code>71205-0192-30</NDC11Code>
<ProductNDC>71205-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078103</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SIMVASTATIN</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>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>71205-192-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71205-192-90) </PackageDescription>
<NDC11Code>71205-0192-90</NDC11Code>
<ProductNDC>71205-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078103</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SIMVASTATIN</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>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10544-192-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (10544-192-60)</PackageDescription>
<NDC11Code>10544-0192-60</NDC11Code>
<ProductNDC>10544-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074223</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with non-insulin-dependent diabetes mellitus (NIDDM; type II), formerly known as maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory. In initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified, and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of glipizide must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone also may be transient, thus requiring only short-term administration of glipizide. During maintenance programs, glipizide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgements should be based on regular clinical and laboratory evaluations. In considering the use of glipizide in asymptomatic patients, it should be recognized that controlling the blood glucose in non-insulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-Cyclohexyl-3-[[ p-[2-(5-methylpyrazinecarboxamido)-ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.54; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>13734-192-60</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13734-192-60) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>13734-0192-60</NDC11Code>
<ProductNDC>13734-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nars Pure Radiant Tinted Moisturizer</ProprietaryName>
<ProprietaryNameSuffix>Granada</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>NARS Cosmetics</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>4.044; 3.996</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunbun. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41226-192-06</NDCCode>
<PackageDescription>60 TABLET, COATED in 1 BOTTLE (41226-192-06) </PackageDescription>
<NDC11Code>41226-0192-06</NDC11Code>
<ProductNDC>41226-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna-s</ProprietaryName>
<NonProprietaryName>Docusate Sodium And Sennosides</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>KROGER</LabelerName>
<SubstanceName>SENNOSIDES; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>8.6; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 Relieves occasional constipation (irregularity), 2 generally causes bowel movement in 6-12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-192-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (42291-192-60) </PackageDescription>
<NDC11Code>42291-0192-60</NDC11Code>
<ProductNDC>42291-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076898</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42507-192-07</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42507-192-07) / 60 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>42507-0192-07</NDC11Code>
<ProductNDC>42507-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211075</ApplicationNumber>
<LabelerName>HYVEE INC</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43744-192-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-192-60)</PackageDescription>
<NDC11Code>43744-0192-60</NDC11Code>
<ProductNDC>43744-192</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cidofovir Anhydrous</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120404</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>CIDOFOVIR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46122-192-60</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (46122-192-60) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46122-0192-60</NDC11Code>
<ProductNDC>46122-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Mucus Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130624</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50228-192-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50228-192-60) </PackageDescription>
<NDC11Code>50228-0192-60</NDC11Code>
<ProductNDC>50228-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205237</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile, soluble in dichloromethane and methanol.</Description>
</NDC>
<NDC>
<NDCCode>51991-192-06</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (51991-192-06) </PackageDescription>
<NDC11Code>51991-0192-06</NDC11Code>
<ProductNDC>51991-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methscopolamine Bromide</ProprietaryName>
<NonProprietaryName>Methscopolamine Bromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040642</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>METHSCOPOLAMINE BROMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.</IndicationAndUsage>
<Description>Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg contain methscopolamine bromide, USP, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform. The chemical name for methscopolamine bromide is 3-Oxa-9-azoniatricyclo [3.3.1.02,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(S)-(1α, 2β, 4β, 5α, 7β)]-and the molecular weight is 398.30. The structural formula is represented below. Methscopolamine Bromide Tablets, USP 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide, USP. Methscopolamine Bromide Tablets, USP 5 mg for oral administration contain 5 mg of methscopolamine bromide, USP.</Description>
</NDC>
<NDC>
<NDCCode>51991-192-60</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 BOX (51991-192-60) / 12 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51991-0192-60</NDC11Code>
<ProductNDC>51991-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methscopolamine Bromide</ProprietaryName>
<NonProprietaryName>Methscopolamine Bromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040642</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>METHSCOPOLAMINE BROMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.</IndicationAndUsage>
<Description>Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg contain methscopolamine bromide, USP, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform. The chemical name for methscopolamine bromide is 3-Oxa-9-azoniatricyclo [3.3.1.02,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(S)-(1α, 2β, 4β, 5α, 7β)]-and the molecular weight is 398.30. The structural formula is represented below. Methscopolamine Bromide Tablets, USP 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide, USP. Methscopolamine Bromide Tablets, USP 5 mg for oral administration contain 5 mg of methscopolamine bromide, USP.</Description>
</NDC>
<NDC>
<NDCCode>52685-192-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52685-192-60) > 40 g in 1 TUBE</PackageDescription>
<NDC11Code>52685-0192-60</NDC11Code>
<ProductNDC>52685-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Smoothing Base For Lines</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>3960</StrengthNumber>
<StrengthUnit>mg/40g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53217-192-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (53217-192-60)</PackageDescription>
<NDC11Code>53217-0192-60</NDC11Code>
<ProductNDC>53217-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040148</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in a variety of strengths as described in the following table. HydrocodoneStrength Bitartrate Acetaminophen. 2.5 mg/325 mg 2.5 mg 325 mg 5 mg/325 mg 5 mg 325 mg. 7.5 mg/325 mg 7.5 mg 325 mg. 10 mg/325 mg 10 mg 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium and magnesium stearate. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>55700-192-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-192-60) </PackageDescription>
<NDC11Code>55700-0192-60</NDC11Code>
<ProductNDC>55700-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090617</ApplicationNumber>
<LabelerName>Quality Care Products LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol 6000, prosolv, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>61442-192-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (61442-192-60) </PackageDescription>
<NDC11Code>61442-0192-60</NDC11Code>
<ProductNDC>61442-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212947</ApplicationNumber>
<LabelerName>Carlsbad Technology, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine Hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, and Triacetin.</Description>
</NDC>
<NDC>
<NDCCode>61919-192-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-192-60) </PackageDescription>
<NDC11Code>61919-0192-60</NDC11Code>
<ProductNDC>61919-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203126</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>I. Vasospastic Angina. Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers. II. Chronic Stable Angina. (Classical Effort-Associated Angina). Nifedipine extended-release tablets are indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina), nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely, since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS). III. Hypertension. Nifedipine extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including nifedipine extended-release tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nifedipine extended-release tablets may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17H 18N 2O 6, and has the structural formula. [image description]. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine GITS (Gastrointestinal Therapeutic System) tablet is formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: cellulose acetate; ferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; potassium chloride; povidone; sodium chloride; titanium dioxide; propylene glycol and black iron oxide. The USP Dissolution Test is pending. System Components and Performance. Nifedipine extended-release tablets are similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, releasing drug through the precision laser-drilled tablet orifice in the active layer. Nifedipine extended-release tablets are designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. Nifedipine extended-release tablets depend for its action on the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the gastrointestinal tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell.</Description>
</NDC>
<NDC>
<NDCCode>63187-192-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (63187-192-60) </PackageDescription>
<NDC11Code>63187-0192-60</NDC11Code>
<ProductNDC>63187-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077309</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir tablet is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablet is a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>71610-192-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71610-192-60) </PackageDescription>
<NDC11Code>71610-0192-60</NDC11Code>
<ProductNDC>71610-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078413</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2019-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem tartrate USP is a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate USP is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3.</Description>
</NDC>
<NDC>
<NDCCode>72789-192-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-192-60) </PackageDescription>
<NDC11Code>72789-0192-60</NDC11Code>
<ProductNDC>72789-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hcl</ProprietaryName>
<NonProprietaryName>Metformin Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090564</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>74913-192-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (74913-192-01) </PackageDescription>
<NDC11Code>74913-0192-01</NDC11Code>
<ProductNDC>74913-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75329-2011-8</NDCCode>
<PackageDescription>192 BOTTLE, PUMP in 1 BOX (75329-2011-8) > 60 mL in 1 BOTTLE, PUMP (75329-2011-1) </PackageDescription>
<NDC11Code>75329-2011-08</NDC11Code>
<ProductNDC>75329-2011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Ningbo Lizi Commodity Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mL/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76177-192-60</NDCCode>
<PackageDescription>60 g in 1 BAG (76177-192-60) </PackageDescription>
<NDC11Code>76177-0192-60</NDC11Code>
<ProductNDC>76177-192</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230110</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sinopep-Allsino Biopharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-12</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-JAN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>83209-192-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BLISTER PACK (83209-192-60) </PackageDescription>
<NDC11Code>83209-0192-60</NDC11Code>
<ProductNDC>83209-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>85766-192-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (85766-192-60) </PackageDescription>
<NDC11Code>85766-0192-60</NDC11Code>
<ProductNDC>85766-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium/misoprostol</ProprietaryName>
<ProprietaryNameSuffix>Diclofenac-sodium-misoprostol</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium/misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204355</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>75; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 69.58 mg of diclofenac) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>86937-005-02</NDCCode>
<PackageDescription>60 PACKAGE in 1 PACKET (86937-005-02) > 3.192 g in 1 PACKAGE</PackageDescription>
<NDC11Code>86937-0005-02</NDC11Code>
<ProductNDC>86937-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fresh N Soft Antibacterial Wet Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201223</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on the skin that could cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87063-192-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (87063-192-60) </PackageDescription>
<NDC11Code>87063-0192-60</NDC11Code>
<ProductNDC>87063-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091491</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (green), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. 500 mg tablets: D&C Yellow #10/aluminum lake and FD&C Blue #1/brilliant blue FCF aluminum lake. 750 mg tablets: FD&C Red #40/alura red AC aluminum lake, FD&C Yellow #6/sunset yellow FCF aluminum lake, and FD&C Blue #1/brilliant blue FCF aluminum lake. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>10812-192-01</NDCCode>
<PackageDescription>141 g in 1 CAN (10812-192-01)</PackageDescription>
<NDC11Code>10812-0192-01</NDC11Code>
<ProductNDC>10812-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Fresh Cooling Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Body Mist Broad Spectrum Spf45</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121018</StartMarketingDate>
<EndMarketingDate>20180805</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 150; 50; 23.5; 60</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-08-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>55150-192-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (55150-192-01) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0192-01</NDC11Code>
<ProductNDC>55150-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adenosine</ProprietaryName>
<NonProprietaryName>Adenosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20171102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205331</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>ADENOSINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.</IndicationAndUsage>
<Description>Adenosine is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenosine has the following structural formula: The molecular formula for adenosine is C10H13N5O4 and its molecular weight is 267.24. Adenosine USP is a white or almost white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH of the solution. Each adenosine injection, USP vial contains a sterile, non-pyrogenic, clear colorless solution of adenosine USP 3 mg/mL and sodium chloride 9 mg/mL in water for injection, with pH between 4.5 and 7.5.</Description>
</NDC>
</NDCList>