{
"NDC": [
{
"NDCCode": "71205-480-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (71205-480-60) ",
"NDC11Code": "71205-0480-60",
"ProductNDC": "71205-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203908",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)] .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-‑piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2."
},
{
"NDCCode": "71205-480-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71205-480-30) ",
"NDC11Code": "71205-0480-30",
"ProductNDC": "71205-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203908",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)] .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-‑piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2."
},
{
"NDCCode": "71205-480-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (71205-480-90) ",
"NDC11Code": "71205-0480-90",
"ProductNDC": "71205-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203908",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)] .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-‑piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2."
},
{
"NDCCode": "16590-480-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-480-60)",
"NDC11Code": "16590-0480-60",
"ProductNDC": "16590-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Stat Rx USA",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol."
},
{
"NDCCode": "18860-480-60",
"PackageDescription": "2 BOTTLE, PUMP in 1 CARTON (18860-480-60) > 35 g in 1 BOTTLE, PUMP (18860-480-01)",
"NDC11Code": "18860-0480-60",
"ProductNDC": "18860-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elestrin",
"NonProprietaryName": "Estradiol",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20070601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021813",
"LabelerName": "Jazz Pharmaceuticals Commercial Corp.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".6",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-02-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "33261-480-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (33261-480-60)",
"NDC11Code": "33261-0480-60",
"ProductNDC": "33261-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079162",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Monotherapy Epilepsy. Topiramate Tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. Adjunctive Therapy Epilepsy. Topiramate Tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate USP has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-Dfructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, lactose monohydrate, sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and), opadry pink (titanium dioxide, hypromellose 6cp, PEG 400, iron oxide red) for 200 mg tablets."
},
{
"NDCCode": "43333-480-60",
"PackageDescription": ".1 mL in 1 POUCH (43333-480-60) ",
"NDC11Code": "43333-0480-60",
"ProductNDC": "43333-480",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200504",
"EndMarketingDate": "20220504",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Tonic Bath & Body Products Shenzhen Ltd",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200504",
"EndMarketingDatePackage": "20220504",
"SamplePackage": "N"
},
{
"NDCCode": "43598-480-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (43598-480-60) ",
"NDC11Code": "43598-0480-60",
"ProductNDC": "43598-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208541",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"Description": "Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a white to pale pink powder with an aqueous solubility of approximately 4 mcg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate, hypromellose, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate, hypromellose, magnesium stearate, mannitol, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "43744-480-60",
"PackageDescription": "750 g in 1 DRUM (43744-480-60)",
"NDC11Code": "43744-0480-60",
"ProductNDC": "43744-480",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110218",
"EndMarketingDate": "20110219",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "HYDROXYZINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20110219"
},
{
"NDCCode": "49999-480-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-480-60)",
"NDC11Code": "49999-0480-60",
"ProductNDC": "49999-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevacid",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19950510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020406",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "58411-480-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-480-60) / 50 mL in 1 TUBE",
"NDC11Code": "58411-0480-60",
"ProductNDC": "58411-480",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Ultimate Sun Protector",
"NonProprietaryName": "Octisalate, Titanium Dioxide, Octocrylene, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "3.105; 2.359; 4.347; 12.047",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. 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": "59088-480-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-480-58) ",
"NDC11Code": "59088-0480-58",
"ProductNDC": "59088-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foliflex",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211025",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211025",
"SamplePackage": "N",
"IndicationAndUsage": "Foliflex TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate) 3000 mcg RAE Vitamin C (as Ascorbic Acid) 500 mg Vitamin D3 (as Cholecalciferol) 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) 90 mg Thiamin (as Thiamine Mononitrate) 6.5 mg Riboflavin 6.7 mg Niacin (as Niacinamide) 45 mg Vitamin B6 (as Pyridoxine HCl) 12 mg Folate 1700 mcg DFE (as L-5-Methyltetrahydrofolate calcium salt) (1000 mcg as L-Methyfolate) Vitamin B12 (as Methylcobalamin) 26 mcg Biotin 200 mcg Pantothenic Acid (as Calcium Pantothenate) 30 mg Calcium (as Calcium Carbonate) 150 mg Iron (as Ferrous Fumarate) 18 mg Iodine (as Potassium Iodide) 50 mcg Magnesium (as Magnesium Oxide) 75 mg Zinc (as Zinc Gluconate) 30 mg Selenium (as Selenomethionine) 60 mcg Copper (as Copper Oxide) 2 mg Manganese (as Manganese Sulfate) 1.5 mg Chromium (as Chromium Polynicotinate) 75 mcg Molybdenum (as Sodium Molybdate) 50 mcg Potassium (as Potassium Chloride) 49 mg Boron (as Boron Citrate) 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "61269-480-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "61269-0480-60",
"ProductNDC": "61269-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valcyte",
"NonProprietaryName": "Valganciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021304",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010329",
"SamplePackage": "N",
"IndicationAndUsage": "VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.",
"Description": "VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir."
},
{
"NDCCode": "61748-480-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (61748-480-60) > 60 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "61748-0480-60",
"ProductNDC": "61748-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "LOTION, AUGMENTED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208849",
"LabelerName": "Versapharm Incorporated",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191115",
"SamplePackage": "N"
},
{
"NDCCode": "68094-480-60",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (68094-480-60) ",
"NDC11Code": "68094-0480-60",
"ProductNDC": "68094-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205096",
"LabelerName": "Precision Dose, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It 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 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol."
},
{
"NDCCode": "70341-480-01",
"PackageDescription": "60 mL in 1 CARTON (70341-480-01)",
"NDC11Code": "70341-0480-01",
"ProductNDC": "70341-480",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure White Brightening Essence",
"NonProprietaryName": "Niacinamide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "The Saem International Co., Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "1.2",
"StrengthUnit": "g/60mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71610-480-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (71610-480-53) ",
"NDC11Code": "71610-0480-53",
"ProductNDC": "71610-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040616",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201103",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium tablets USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows. C19H15NaO4 M.W. 330.31. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&C red no. 40. The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake. The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake. The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake. The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake. The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 7.5 mg also contains FD&C yellow no. 5 (tartrazine) aluminum lake and FD&C red no. 40 aluminum lake."
},
{
"NDCCode": "71610-480-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-480-60) ",
"NDC11Code": "71610-0480-60",
"ProductNDC": "71610-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040616",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201103",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium tablets USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows. C19H15NaO4 M.W. 330.31. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&C red no. 40. The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake. The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake. The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake. The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake. The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 7.5 mg also contains FD&C yellow no. 5 (tartrazine) aluminum lake and FD&C red no. 40 aluminum lake."
},
{
"NDCCode": "71205-539-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-539-60) ",
"NDC11Code": "71205-0539-60",
"ProductNDC": "71205-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211657",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210225",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S )-(3R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2∙C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to light yellow powder. It is freely soluble at room temperature in water, and ethanol. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, talc, and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet)."
},
{
"NDCCode": "71205-540-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-540-60) ",
"NDC11Code": "71205-0540-60",
"ProductNDC": "71205-540",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211657",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210225",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S )-(3R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2∙C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to light yellow powder. It is freely soluble at room temperature in water, and ethanol. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, talc, and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet)."
},
{
"NDCCode": "71205-559-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-559-60) ",
"NDC11Code": "71205-0559-60",
"ProductNDC": "71205-559",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209333",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210505",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S)-(3 R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white or light yellow powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol and titanium dioxide with iron oxide yellow (5 mg solifenacin succinate tablet) or iron oxide red (10 mg solifenacin succinate tablet)."
},
{
"NDCCode": "71205-561-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-561-60) ",
"NDC11Code": "71205-0561-60",
"ProductNDC": "71205-561",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210224",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210507",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate. The coating material contains hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet)."
},
{
"NDCCode": "71205-580-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-580-60) ",
"NDC11Code": "71205-0580-60",
"ProductNDC": "71205-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succiate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210281",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210625",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "71205-583-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-583-60) ",
"NDC11Code": "71205-0583-60",
"ProductNDC": "71205-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209333",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210625",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S)-(3 R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white or light yellow powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol and titanium dioxide with iron oxide yellow (5 mg solifenacin succinate tablet) or iron oxide red (10 mg solifenacin succinate tablet)."
},
{
"NDCCode": "71205-933-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-933-60) ",
"NDC11Code": "71205-0933-60",
"ProductNDC": "71205-933",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succiate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210281",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210319",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "71205-934-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-934-60) ",
"NDC11Code": "71205-0934-60",
"ProductNDC": "71205-934",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210281",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210319",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "71205-986-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-986-60) ",
"NDC11Code": "71205-0986-60",
"ProductNDC": "71205-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211657",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2∙C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to light yellow powder. It is freely soluble at room temperature in water, and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, talc, and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet)."
},
{
"NDCCode": "71205-987-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-987-60) ",
"NDC11Code": "71205-0987-60",
"ProductNDC": "71205-987",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211657",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2∙C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to light yellow powder. It is freely soluble at room temperature in water, and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, talc, and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet)."
},
{
"NDCCode": "71205-001-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (71205-001-60) ",
"NDC11Code": "71205-0001-60",
"ProductNDC": "71205-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088628",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia,, 2 Have not been tolerated, or are not expected to be tolerated.",
"Description": "Acetaminophen and codeine phosphate are supplied in tablet form for oral administration. Acetaminophen, USP, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. 151.16. Codeine phosphate, USP, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. C18H21NO3H3PO4½H2O M.W. 406.37. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/15 mg) contains: 1 Acetaminophen, USP...........................300 mgCodeine Phosphate, USP.......................15 mg."
},
{
"NDCCode": "71205-003-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (71205-003-60) ",
"NDC11Code": "71205-0003-60",
"ProductNDC": "71205-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202871",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180402",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.",
"Description": "Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents."
}
]
}
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<NDC>
<NDCCode>71205-480-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-480-60) </PackageDescription>
<NDC11Code>71205-0480-60</NDC11Code>
<ProductNDC>71205-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203908</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)] .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-‑piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-480-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71205-480-30) </PackageDescription>
<NDC11Code>71205-0480-30</NDC11Code>
<ProductNDC>71205-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203908</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)] .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-‑piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-480-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71205-480-90) </PackageDescription>
<NDC11Code>71205-0480-90</NDC11Code>
<ProductNDC>71205-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203908</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)] .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-‑piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2.</Description>
</NDC>
<NDC>
<NDCCode>16590-480-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-480-60)</PackageDescription>
<NDC11Code>16590-0480-60</NDC11Code>
<ProductNDC>16590-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>18860-480-60</NDCCode>
<PackageDescription>2 BOTTLE, PUMP in 1 CARTON (18860-480-60) > 35 g in 1 BOTTLE, PUMP (18860-480-01)</PackageDescription>
<NDC11Code>18860-0480-60</NDC11Code>
<ProductNDC>18860-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elestrin</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20070601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021813</ApplicationNumber>
<LabelerName>Jazz Pharmaceuticals Commercial Corp.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>33261-480-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (33261-480-60)</PackageDescription>
<NDC11Code>33261-0480-60</NDC11Code>
<ProductNDC>33261-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079162</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Monotherapy Epilepsy. Topiramate Tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. Adjunctive Therapy Epilepsy. Topiramate Tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate USP has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-Dfructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, lactose monohydrate, sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and), opadry pink (titanium dioxide, hypromellose 6cp, PEG 400, iron oxide red) for 200 mg tablets.</Description>
</NDC>
<NDC>
<NDCCode>43333-480-60</NDCCode>
<PackageDescription>.1 mL in 1 POUCH (43333-480-60) </PackageDescription>
<NDC11Code>43333-0480-60</NDC11Code>
<ProductNDC>43333-480</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200504</StartMarketingDate>
<EndMarketingDate>20220504</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Tonic Bath & Body Products Shenzhen Ltd</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200504</StartMarketingDatePackage>
<EndMarketingDatePackage>20220504</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43598-480-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (43598-480-60) </PackageDescription>
<NDC11Code>43598-0480-60</NDC11Code>
<ProductNDC>43598-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208541</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a white to pale pink powder with an aqueous solubility of approximately 4 mcg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate, hypromellose, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate, hypromellose, magnesium stearate, mannitol, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43744-480-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-480-60)</PackageDescription>
<NDC11Code>43744-0480-60</NDC11Code>
<ProductNDC>43744-480</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110218</StartMarketingDate>
<EndMarketingDate>20110219</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>HYDROXYZINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20110219</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49999-480-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-480-60)</PackageDescription>
<NDC11Code>49999-0480-60</NDC11Code>
<ProductNDC>49999-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevacid</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020406</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>58411-480-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-480-60) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0480-60</NDC11Code>
<ProductNDC>58411-480</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Ultimate Sun Protector</ProprietaryName>
<NonProprietaryName>Octisalate, Titanium Dioxide, Octocrylene, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>3.105; 2.359; 4.347; 12.047</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. 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>59088-480-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-480-58) </PackageDescription>
<NDC11Code>59088-0480-58</NDC11Code>
<ProductNDC>59088-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foliflex</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211025</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Foliflex TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate) 3000 mcg RAE Vitamin C (as Ascorbic Acid) 500 mg Vitamin D3 (as Cholecalciferol) 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) 90 mg Thiamin (as Thiamine Mononitrate) 6.5 mg Riboflavin 6.7 mg Niacin (as Niacinamide) 45 mg Vitamin B6 (as Pyridoxine HCl) 12 mg Folate 1700 mcg DFE (as L-5-Methyltetrahydrofolate calcium salt) (1000 mcg as L-Methyfolate) Vitamin B12 (as Methylcobalamin) 26 mcg Biotin 200 mcg Pantothenic Acid (as Calcium Pantothenate) 30 mg Calcium (as Calcium Carbonate) 150 mg Iron (as Ferrous Fumarate) 18 mg Iodine (as Potassium Iodide) 50 mcg Magnesium (as Magnesium Oxide) 75 mg Zinc (as Zinc Gluconate) 30 mg Selenium (as Selenomethionine) 60 mcg Copper (as Copper Oxide) 2 mg Manganese (as Manganese Sulfate) 1.5 mg Chromium (as Chromium Polynicotinate) 75 mcg Molybdenum (as Sodium Molybdate) 50 mcg Potassium (as Potassium Chloride) 49 mg Boron (as Boron Citrate) 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>61269-480-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>61269-0480-60</NDC11Code>
<ProductNDC>61269-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valcyte</ProprietaryName>
<NonProprietaryName>Valganciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021304</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
<Description>VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>61748-480-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (61748-480-60) > 60 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>61748-0480-60</NDC11Code>
<ProductNDC>61748-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>LOTION, AUGMENTED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208849</ApplicationNumber>
<LabelerName>Versapharm Incorporated</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68094-480-60</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE (68094-480-60) </PackageDescription>
<NDC11Code>68094-0480-60</NDC11Code>
<ProductNDC>68094-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205096</ApplicationNumber>
<LabelerName>Precision Dose, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It 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 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>70341-480-01</NDCCode>
<PackageDescription>60 mL in 1 CARTON (70341-480-01)</PackageDescription>
<NDC11Code>70341-0480-01</NDC11Code>
<ProductNDC>70341-480</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure White Brightening Essence</ProprietaryName>
<NonProprietaryName>Niacinamide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>The Saem International Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71610-480-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71610-480-53) </PackageDescription>
<NDC11Code>71610-0480-53</NDC11Code>
<ProductNDC>71610-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040616</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium tablets USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows. C19H15NaO4 M.W. 330.31. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&C red no. 40. The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake. The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake. The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake. The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake. The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 7.5 mg also contains FD&C yellow no. 5 (tartrazine) aluminum lake and FD&C red no. 40 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>71610-480-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-480-60) </PackageDescription>
<NDC11Code>71610-0480-60</NDC11Code>
<ProductNDC>71610-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040616</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium tablets USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows. C19H15NaO4 M.W. 330.31. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&C red no. 40. The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake. The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake. The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake. The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake. The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 7.5 mg also contains FD&C yellow no. 5 (tartrazine) aluminum lake and FD&C red no. 40 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>71205-539-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-539-60) </PackageDescription>
<NDC11Code>71205-0539-60</NDC11Code>
<ProductNDC>71205-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211657</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S )-(3R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2∙C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to light yellow powder. It is freely soluble at room temperature in water, and ethanol. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, talc, and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
</NDC>
<NDC>
<NDCCode>71205-540-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-540-60) </PackageDescription>
<NDC11Code>71205-0540-60</NDC11Code>
<ProductNDC>71205-540</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211657</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S )-(3R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2∙C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to light yellow powder. It is freely soluble at room temperature in water, and ethanol. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, talc, and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
</NDC>
<NDC>
<NDCCode>71205-559-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-559-60) </PackageDescription>
<NDC11Code>71205-0559-60</NDC11Code>
<ProductNDC>71205-559</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209333</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S)-(3 R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white or light yellow powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol and titanium dioxide with iron oxide yellow (5 mg solifenacin succinate tablet) or iron oxide red (10 mg solifenacin succinate tablet).</Description>
</NDC>
<NDC>
<NDCCode>71205-561-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-561-60) </PackageDescription>
<NDC11Code>71205-0561-60</NDC11Code>
<ProductNDC>71205-561</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210224</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate. The coating material contains hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
</NDC>
<NDC>
<NDCCode>71205-580-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-580-60) </PackageDescription>
<NDC11Code>71205-0580-60</NDC11Code>
<ProductNDC>71205-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succiate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210281</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-583-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-583-60) </PackageDescription>
<NDC11Code>71205-0583-60</NDC11Code>
<ProductNDC>71205-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209333</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S)-(3 R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white or light yellow powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol and titanium dioxide with iron oxide yellow (5 mg solifenacin succinate tablet) or iron oxide red (10 mg solifenacin succinate tablet).</Description>
</NDC>
<NDC>
<NDCCode>71205-933-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-933-60) </PackageDescription>
<NDC11Code>71205-0933-60</NDC11Code>
<ProductNDC>71205-933</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succiate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210281</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-934-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-934-60) </PackageDescription>
<NDC11Code>71205-0934-60</NDC11Code>
<ProductNDC>71205-934</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210281</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-986-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-986-60) </PackageDescription>
<NDC11Code>71205-0986-60</NDC11Code>
<ProductNDC>71205-986</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211657</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2∙C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to light yellow powder. It is freely soluble at room temperature in water, and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, talc, and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
</NDC>
<NDC>
<NDCCode>71205-987-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-987-60) </PackageDescription>
<NDC11Code>71205-0987-60</NDC11Code>
<ProductNDC>71205-987</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211657</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2∙C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to light yellow powder. It is freely soluble at room temperature in water, and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 8000, talc, and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
</NDC>
<NDC>
<NDCCode>71205-001-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-001-60) </PackageDescription>
<NDC11Code>71205-0001-60</NDC11Code>
<ProductNDC>71205-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088628</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia,, 2 Have not been tolerated, or are not expected to be tolerated.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate are supplied in tablet form for oral administration. Acetaminophen, USP, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. 151.16. Codeine phosphate, USP, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. C18H21NO3H3PO4½H2O M.W. 406.37. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/15 mg) contains: 1 Acetaminophen, USP...........................300 mgCodeine Phosphate, USP.......................15 mg.</Description>
</NDC>
<NDC>
<NDCCode>71205-003-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-003-60) </PackageDescription>
<NDC11Code>71205-0003-60</NDC11Code>
<ProductNDC>71205-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202871</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.</IndicationAndUsage>
<Description>Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents.</Description>
</NDC>
</NDCList>