{
"NDC": [
{
"NDCCode": "71610-435-53",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71610-435-53) ",
"NDC11Code": "71610-0435-53",
"ProductNDC": "71610-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200616",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "71610-435-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71610-435-60) ",
"NDC11Code": "71610-0435-60",
"ProductNDC": "71610-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200630",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "71610-435-45",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (71610-435-45) ",
"NDC11Code": "71610-0435-45",
"ProductNDC": "71610-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200616",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "71610-435-73",
"PackageDescription": "135 TABLET, FILM COATED in 1 BOTTLE (71610-435-73) ",
"NDC11Code": "71610-0435-73",
"ProductNDC": "71610-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200616",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "71610-435-80",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (71610-435-80) ",
"NDC11Code": "71610-0435-80",
"ProductNDC": "71610-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200616",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "13537-435-01",
"PackageDescription": "60 g in 1 TUBE (13537-435-01)",
"NDC11Code": "13537-0435-01",
"ProductNDC": "13537-435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyzone",
"ProprietaryNameSuffix": "Sun By Me Face Screen Fps 50 Amplio Espectro",
"NonProprietaryName": "Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, And Ensulizole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD.",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE; ENSULIZOLE",
"StrengthNumber": ".075; .07; .06; .05; .468; .03",
"StrengthUnit": "g/g; g/g; g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ayuda a prevenir quemaduras solares. Si se usa según las indicaciones con otras medidas de protección (ver Instrucciones), disminuye el riesgo de cancer en la piel y el envejecimiento prematuro causados por el sol."
},
{
"NDCCode": "20276-435-60",
"PackageDescription": "60 CLOTH in 1 PACKAGE (20276-435-60) ",
"NDC11Code": "20276-0435-60",
"ProductNDC": "20276-435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wet Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200518",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Delta Brands, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200518",
"SamplePackage": "N",
"IndicationAndUsage": "decreases bacteria on the skin."
},
{
"NDCCode": "43547-435-06",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-435-06) ",
"NDC11Code": "43547-0435-06",
"ProductNDC": "43547-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209757",
"LabelerName": "Solco Healthcare LLC",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180215",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride extended-release tablets is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].",
"Description": "Clonidine hydrochloride extended-release tablets is a centrally acting alpha2-adrenergic agonist available as 0.1 mg extended-release tablets for oral administration. Each 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are sodium lauryl sulfate, lactose monohydrate, hypromellose type 2208, partially pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. The formulation is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. C9H9Cl2N3·HCl Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "43744-435-60",
"PackageDescription": "750 g in 1 DRUM (43744-435-60)",
"NDC11Code": "43744-0435-60",
"ProductNDC": "43744-435",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20111101",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "52959-435-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (52959-435-60)",
"NDC11Code": "52959-0435-60",
"ProductNDC": "52959-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040517",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.",
"Description": "Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "55700-435-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-435-60) ",
"NDC11Code": "55700-0435-60",
"ProductNDC": "55700-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202045",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170929",
"SamplePackage": "N"
},
{
"NDCCode": "61919-435-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (61919-435-60) ",
"NDC11Code": "61919-0435-60",
"ProductNDC": "61919-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074132",
"LabelerName": "Direct Rx",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.8. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, silicone fluid, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6."
},
{
"NDCCode": "63481-435-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63481-435-60)",
"NDC11Code": "63481-0435-60",
"ProductNDC": "63481-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opana",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Oxymorphone Hydrochoride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201655",
"LabelerName": "Endo Pharmaceuticals Inc.",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2015-01-30"
},
{
"NDCCode": "72205-435-03",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-03) ",
"NDC11Code": "72205-0435-03",
"ProductNDC": "72205-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211479",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260409",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black."
},
{
"NDCCode": "83676-435-00",
"PackageDescription": "60 mL in 1 JAR (83676-435-00) ",
"NDC11Code": "83676-0435-00",
"ProductNDC": "83676-435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure Ease Joint Muscle Lnstant Pain Relief",
"NonProprietaryName": "Capsaicin, Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231127",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "SERENU, INC.",
"SubstanceName": "CAPSAICIN; MENTHOL",
"StrengthNumber": ".25; 80",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. Provides cooling pain relief."
},
{
"NDCCode": "98132-435-60",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (98132-435-60) / 34.65 g in 1 BOTTLE, GLASS",
"NDC11Code": "98132-0435-60",
"ProductNDC": "98132-435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bareminerals Barepro 24hr Wear Skin-perfecting Matte Liquid Foundation",
"ProprietaryNameSuffix": "Deep 56 Cool",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Orveon Global US LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "2.1483",
"StrengthUnit": "g/34.65g",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"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": "71610-327-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71610-327-60) ",
"NDC11Code": "71610-0327-60",
"ProductNDC": "71610-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan And Hydrochlorothiazide",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203145",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE; VALSARTAN",
"StrengthNumber": "25; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190815",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. Initial Therapy Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)]provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8. Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8. Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8. Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8 For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP, are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "71610-003-60",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-003-60) ",
"NDC11Code": "71610-0003-60",
"ProductNDC": "71610-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202038",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170808",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg).Each pantoprazole sodium delayed-release tablets, USP contain 45.1 mg or 22.56 mg of pantoprazole sodium USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3."
},
{
"NDCCode": "71610-004-53",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71610-004-53) ",
"NDC11Code": "71610-0004-53",
"ProductNDC": "71610-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100223",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018163",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2019-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171122",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam Capsules USP are benzodiazepine hypnotic agents. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules USP, 7.5 mg and 22.5 mg, are for oral administration."
},
{
"NDCCode": "71610-004-60",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71610-004-60) ",
"NDC11Code": "71610-0004-60",
"ProductNDC": "71610-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100223",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018163",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2019-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171122",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam Capsules USP are benzodiazepine hypnotic agents. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules USP, 7.5 mg and 22.5 mg, are for oral administration."
},
{
"NDCCode": "71610-005-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (71610-005-60) ",
"NDC11Code": "71610-0005-60",
"ProductNDC": "71610-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primidone",
"NonProprietaryName": "Primidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040586",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PRIMIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170920",
"SamplePackage": "N",
"IndicationAndUsage": "Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.",
"Description": "Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula. Primidone is a white, crystalline, highly stable substance, M.P. 279-284° C. It is poorly soluble in water (60 mg per 100 mL at 37° C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog."
},
{
"NDCCode": "71610-006-53",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71610-006-53) ",
"NDC11Code": "71610-0006-53",
"ProductNDC": "71610-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075977",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2019-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171006",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Tramadol Hydrochloride Tablets USP are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Its structural formula is. C16H25NO2HCl M.W. 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets USP contain 50 mg of tramadol hydrochloride, USP and are white in color. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "71610-006-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71610-006-60) ",
"NDC11Code": "71610-0006-60",
"ProductNDC": "71610-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075977",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2019-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171006",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Tramadol Hydrochloride Tablets USP are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Its structural formula is. C16H25NO2HCl M.W. 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets USP contain 50 mg of tramadol hydrochloride, USP and are white in color. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "71610-008-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (71610-008-53) ",
"NDC11Code": "71610-0008-53",
"ProductNDC": "71610-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078203",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2019-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171024",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate."
},
{
"NDCCode": "71610-008-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-008-60) ",
"NDC11Code": "71610-0008-60",
"ProductNDC": "71610-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078203",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2019-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171024",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate."
},
{
"NDCCode": "71610-009-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71610-009-60) ",
"NDC11Code": "71610-0009-60",
"ProductNDC": "71610-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076958",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171218",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium tablets USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its structural formula is:. C22H22ClKN6O M.W. 461.01. Losartan potassium, USP is a white to off-white free-flowing crystalline powder. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: D&C Yellow #10 aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide. Additionally, 50 mg and 100 mg tablets contain FD&C Yellow #6/sunset yellow FCF aluminum lake. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "71610-012-60",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-60) ",
"NDC11Code": "71610-0012-60",
"ProductNDC": "71610-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20001204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075269",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171115",
"SamplePackage": "N",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2 -nitrophenyl)-, dimethyl ester. The molecular formula is C 17H 18N 2O 6and has the structural formula:. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and methyl methacrylate), polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide. Nifedipine extended-release tablets meet USP Dissolution Test 4."
},
{
"NDCCode": "71610-013-53",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-013-53) ",
"NDC11Code": "71610-0013-53",
"ProductNDC": "71610-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110602",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020699",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contain venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "71610-014-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (71610-014-53) ",
"NDC11Code": "71610-0014-53",
"ProductNDC": "71610-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083177",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180108",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate."
},
{
"NDCCode": "71610-014-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-014-60) ",
"NDC11Code": "71610-0014-60",
"ProductNDC": "71610-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083177",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate."
}
]
}
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<NDC>
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<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71610-435-53) </PackageDescription>
<NDC11Code>71610-0435-53</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
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<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>71610-435-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71610-435-60) </PackageDescription>
<NDC11Code>71610-0435-60</NDC11Code>
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<LastUpdate>2020-07-21</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>71610-435-45</NDCCode>
<PackageDescription>45 TABLET, FILM COATED in 1 BOTTLE (71610-435-45) </PackageDescription>
<NDC11Code>71610-0435-45</NDC11Code>
<ProductNDC>71610-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>71610-435-73</NDCCode>
<PackageDescription>135 TABLET, FILM COATED in 1 BOTTLE (71610-435-73) </PackageDescription>
<NDC11Code>71610-0435-73</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>71610-435-80</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (71610-435-80) </PackageDescription>
<NDC11Code>71610-0435-80</NDC11Code>
<ProductNDC>71610-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>13537-435-01</NDCCode>
<PackageDescription>60 g in 1 TUBE (13537-435-01)</PackageDescription>
<NDC11Code>13537-0435-01</NDC11Code>
<ProductNDC>13537-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyzone</ProprietaryName>
<ProprietaryNameSuffix>Sun By Me Face Screen Fps 50 Amplio Espectro</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, And Ensulizole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD.</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE; ENSULIZOLE</SubstanceName>
<StrengthNumber>.075; .07; .06; .05; .468; .03</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ayuda a prevenir quemaduras solares. Si se usa según las indicaciones con otras medidas de protección (ver Instrucciones), disminuye el riesgo de cancer en la piel y el envejecimiento prematuro causados por el sol.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>20276-435-60</NDCCode>
<PackageDescription>60 CLOTH in 1 PACKAGE (20276-435-60) </PackageDescription>
<NDC11Code>20276-0435-60</NDC11Code>
<ProductNDC>20276-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wet Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200518</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Delta Brands, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>decreases bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43547-435-06</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-435-06) </PackageDescription>
<NDC11Code>43547-0435-06</NDC11Code>
<ProductNDC>43547-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209757</ApplicationNumber>
<LabelerName>Solco Healthcare LLC</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride extended-release tablets is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Clonidine hydrochloride extended-release tablets is a centrally acting alpha2-adrenergic agonist available as 0.1 mg extended-release tablets for oral administration. Each 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are sodium lauryl sulfate, lactose monohydrate, hypromellose type 2208, partially pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. The formulation is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. C9H9Cl2N3·HCl Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>43744-435-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-435-60)</PackageDescription>
<NDC11Code>43744-0435-60</NDC11Code>
<ProductNDC>43744-435</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20111101</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52959-435-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (52959-435-60)</PackageDescription>
<NDC11Code>52959-0435-60</NDC11Code>
<ProductNDC>52959-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040517</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55700-435-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-435-60) </PackageDescription>
<NDC11Code>55700-0435-60</NDC11Code>
<ProductNDC>55700-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202045</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61919-435-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (61919-435-60) </PackageDescription>
<NDC11Code>61919-0435-60</NDC11Code>
<ProductNDC>61919-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074132</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.8. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, silicone fluid, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>63481-435-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63481-435-60)</PackageDescription>
<NDC11Code>63481-0435-60</NDC11Code>
<ProductNDC>63481-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opana</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Oxymorphone Hydrochoride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201655</ApplicationNumber>
<LabelerName>Endo Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>72205-435-03</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-03) </PackageDescription>
<NDC11Code>72205-0435-03</NDC11Code>
<ProductNDC>72205-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211479</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>83676-435-00</NDCCode>
<PackageDescription>60 mL in 1 JAR (83676-435-00) </PackageDescription>
<NDC11Code>83676-0435-00</NDC11Code>
<ProductNDC>83676-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure Ease Joint Muscle Lnstant Pain Relief</ProprietaryName>
<NonProprietaryName>Capsaicin, Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>SERENU, INC.</LabelerName>
<SubstanceName>CAPSAICIN; MENTHOL</SubstanceName>
<StrengthNumber>.25; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. Provides cooling pain relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>98132-435-60</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (98132-435-60) / 34.65 g in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>98132-0435-60</NDC11Code>
<ProductNDC>98132-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bareminerals Barepro 24hr Wear Skin-perfecting Matte Liquid Foundation</ProprietaryName>
<ProprietaryNameSuffix>Deep 56 Cool</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Orveon Global US LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>2.1483</StrengthNumber>
<StrengthUnit>g/34.65g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</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>71610-327-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71610-327-60) </PackageDescription>
<NDC11Code>71610-0327-60</NDC11Code>
<ProductNDC>71610-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203145</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
<StrengthNumber>25; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. Initial Therapy Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)]provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8. Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8. Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8. Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8 For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP, are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-003-60</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-003-60) </PackageDescription>
<NDC11Code>71610-0003-60</NDC11Code>
<ProductNDC>71610-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202038</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg).Each pantoprazole sodium delayed-release tablets, USP contain 45.1 mg or 22.56 mg of pantoprazole sodium USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>71610-004-53</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71610-004-53) </PackageDescription>
<NDC11Code>71610-0004-53</NDC11Code>
<ProductNDC>71610-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100223</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018163</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2019-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam Capsules USP are benzodiazepine hypnotic agents. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules USP, 7.5 mg and 22.5 mg, are for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>71610-004-60</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71610-004-60) </PackageDescription>
<NDC11Code>71610-0004-60</NDC11Code>
<ProductNDC>71610-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100223</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018163</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2019-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam Capsules USP are benzodiazepine hypnotic agents. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules USP, 7.5 mg and 22.5 mg, are for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>71610-005-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (71610-005-60) </PackageDescription>
<NDC11Code>71610-0005-60</NDC11Code>
<ProductNDC>71610-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primidone</ProprietaryName>
<NonProprietaryName>Primidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040586</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PRIMIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.</IndicationAndUsage>
<Description>Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula. Primidone is a white, crystalline, highly stable substance, M.P. 279-284° C. It is poorly soluble in water (60 mg per 100 mL at 37° C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog.</Description>
</NDC>
<NDC>
<NDCCode>71610-006-53</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71610-006-53) </PackageDescription>
<NDC11Code>71610-0006-53</NDC11Code>
<ProductNDC>71610-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075977</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2019-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Tramadol Hydrochloride Tablets USP are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Its structural formula is. C16H25NO2HCl M.W. 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets USP contain 50 mg of tramadol hydrochloride, USP and are white in color. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-006-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71610-006-60) </PackageDescription>
<NDC11Code>71610-0006-60</NDC11Code>
<ProductNDC>71610-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075977</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2019-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Tramadol Hydrochloride Tablets USP are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Its structural formula is. C16H25NO2HCl M.W. 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets USP contain 50 mg of tramadol hydrochloride, USP and are white in color. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-008-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71610-008-53) </PackageDescription>
<NDC11Code>71610-0008-53</NDC11Code>
<ProductNDC>71610-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078203</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2019-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71610-008-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-008-60) </PackageDescription>
<NDC11Code>71610-0008-60</NDC11Code>
<ProductNDC>71610-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078203</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2019-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71610-009-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71610-009-60) </PackageDescription>
<NDC11Code>71610-0009-60</NDC11Code>
<ProductNDC>71610-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076958</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium tablets USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its structural formula is:. C22H22ClKN6O M.W. 461.01. Losartan potassium, USP is a white to off-white free-flowing crystalline powder. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: D&C Yellow #10 aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide. Additionally, 50 mg and 100 mg tablets contain FD&C Yellow #6/sunset yellow FCF aluminum lake. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>71610-012-60</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-60) </PackageDescription>
<NDC11Code>71610-0012-60</NDC11Code>
<ProductNDC>71610-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075269</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2 -nitrophenyl)-, dimethyl ester. The molecular formula is C 17H 18N 2O 6and has the structural formula:. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and methyl methacrylate), polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide. Nifedipine extended-release tablets meet USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>71610-013-53</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-013-53) </PackageDescription>
<NDC11Code>71610-0013-53</NDC11Code>
<ProductNDC>71610-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110602</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contain venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-014-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71610-014-53) </PackageDescription>
<NDC11Code>71610-0014-53</NDC11Code>
<ProductNDC>71610-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083177</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71610-014-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-014-60) </PackageDescription>
<NDC11Code>71610-0014-60</NDC11Code>
<ProductNDC>71610-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083177</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate.</Description>
</NDC>
</NDCList>