{
"NDC": [
{
"NDCCode": "53217-245-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (53217-245-60)",
"NDC11Code": "53217-0245-60",
"ProductNDC": "53217-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078627",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. 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.Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "53217-245-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (53217-245-30)",
"NDC11Code": "53217-0245-30",
"ProductNDC": "53217-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078627",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. 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.Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "53217-245-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (53217-245-90)",
"NDC11Code": "53217-0245-90",
"ProductNDC": "53217-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078627",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. 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.Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "24658-245-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (24658-245-60)",
"NDC11Code": "24658-0245-60",
"ProductNDC": "24658-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076063",
"LabelerName": "Blu Pharmaceuticals, LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-09"
},
{
"NDCCode": "27808-245-01",
"PackageDescription": "60 TABLET in 1 BOTTLE (27808-245-01) ",
"NDC11Code": "27808-0245-01",
"ProductNDC": "27808-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208308",
"LabelerName": "Tris Pharma Inc",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2023-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220319",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1).",
"Description": "The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "49999-245-60",
"PackageDescription": "60 TABLET in 1 VIAL (49999-245-60)",
"NDC11Code": "49999-0245-60",
"ProductNDC": "49999-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090637",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "52686-245-60",
"PackageDescription": "1 TUBE in 1 CARTON (52686-245-60) > 33.45 g in 1 TUBE",
"NDC11Code": "52686-0245-60",
"ProductNDC": "52686-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Perfect Refining Foundation",
"ProprietaryNameSuffix": "O60",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICA INC.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".63555; 1.37145",
"StrengthUnit": "g/33.45g; g/33.45g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110201",
"SamplePackage": "N"
},
{
"NDCCode": "52959-245-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (52959-245-60)",
"NDC11Code": "52959-0245-60",
"ProductNDC": "52959-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoprofen",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073516",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketoprofen capsules and other treatment options before deciding to use ketoprofen capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules are indicated for the management of pain. Ketoprofen capsules are also indicated for treatment of primary dysmenorrhea.",
"Description": "Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. C16H14O3 M.W. 254.29. It has a pKa of 5.94 in methanol: water (3:1) and an n-octanol: water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Ketoprofen capsules contain 50 mg or 75 mg of ketoprofen for oral administration."
},
{
"NDCCode": "59088-245-06",
"PackageDescription": "60 g in 1 JAR (59088-245-06) ",
"NDC11Code": "59088-0245-06",
"ProductNDC": "59088-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methylten 25%",
"ProprietaryNameSuffix": "Pain Relieving",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains."
},
{
"NDCCode": "61919-245-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-245-60) ",
"NDC11Code": "61919-0245-60",
"ProductNDC": "61919-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "DIRECT RX",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Short-Term Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer. [See Clinical Studies (14)] 1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole delayed-release capsules /amoxicillin /clarithromycinLansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See Clinical Studies (14)] Please refer to the full prescribing information for amoxicillin and clarithromycin.Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin Dual Therapy: Lansoprazole delayed-release capsules /amoxicillinLansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See Clinical Studies (14)] Please refer to the full prescribing information for amoxicillin.1.3 Maintenance of Healed Duodenal Ulcers Lansoprazole delayed-release capsules are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14)] 1.4 Short-Term Treatment of Active Benign Gastric Ulcer Lansoprazole delayed-release capsules are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer. [See Clinical Studies (14)] 1.5 Healing of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks. [See Clinical Studies (14)] 1.6 Risk Reduction of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules are indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. [See Clinical Studies (14)] 1.7 Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERDLansoprazole delayed-release capsules is indicated for the treatment of heartburn and other symptoms associated with GERD for upto 8 weeks. [See Clinical Studies (14)] Short-Term Treatment of Erosive EsophagitisLansoprazole delayed-release capsules is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of lansoprazole delayed-release capsules may be considered. [See Clinical Studies (14)] 1.8 Maintenance of Healing of Erosive Esophagitis (EE) Lansoprazole delayed-release capsules are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. [See Clinical Studies (14)] 1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) Lansoprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. [See Clinical Studies (14)] .",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamideand practically insoluble in water. Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole USP is supplied as delayed-release capsules. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules."
},
{
"NDCCode": "67544-245-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (67544-245-60) ",
"NDC11Code": "67544-0245-60",
"ProductNDC": "67544-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011217",
"EndMarketingDate": "20210531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075636",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040817",
"EndMarketingDatePackage": "20210531",
"SamplePackage": "N"
},
{
"NDCCode": "68462-245-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (68462-245-60)",
"NDC11Code": "68462-0245-60",
"ProductNDC": "68462-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090169",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "69539-245-34",
"PackageDescription": "60 TABLET in 1 BOX (69539-245-34) ",
"NDC11Code": "69539-0245-34",
"ProductNDC": "69539-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asenapine",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20210827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205960",
"LabelerName": "MSN LABORATORIES PRIVATE LIMITED",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2021-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210827",
"SamplePackage": "N",
"IndicationAndUsage": "Asenapine sublingual tablets are indicated for: 1 Schizophrenia in adults [see Clinical Studies (14.1)], 2 Bipolar I disorder [see Clinical Studies (14.2)]Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of ageAdjunctive treatment to lithium or valproate in adultsMaintenance monotherapy treatment in adults.",
"Description": "Asenapine sublingual tablets contain asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is(3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole(2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO.C4H4O4 and its molecular weight is 401.84 (free base: 285.8). The chemical structure is. Asenapine maleate is a white to off-white powder. Asenapine sublingual tablets (Unflavored) are supplied for sublingual administration in tablets containing 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone. Asenapine sublingual tablets, black cherry flavor, are supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone and black cherry flavor (components are nature identical flavorings, natural flavoring substances, natural flavoring complexes, maize maltodextrin and moisture)."
},
{
"NDCCode": "69865-245-02",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69865-245-02) ",
"NDC11Code": "69865-0245-02",
"ProductNDC": "69865-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucynta",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200533",
"LabelerName": "Depo NF Sub, LLC",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170616",
"SamplePackage": "N",
"IndicationAndUsage": "NUCYNTA ER (tapentadol) is indicated for the management of: 1 pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, 2 neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.",
"Description": "NUCYNTA ER (tapentadol) is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n- octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
},
{
"NDCCode": "71205-245-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (71205-245-60) ",
"NDC11Code": "71205-0245-60",
"ProductNDC": "71205-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090170",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190401",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine Tablets are indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. It's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&C Blue No. 2 Lake."
},
{
"NDCCode": "71610-245-60",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (71610-245-60) ",
"NDC11Code": "71610-0245-60",
"ProductNDC": "71610-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rugby Travel Sickness",
"ProprietaryNameSuffix": "Meclizine Hcl, 25 Mg Each (antiemetic)",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140819",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part336",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190228",
"SamplePackage": "N",
"IndicationAndUsage": "Uses prevents and treats nausea, vomiting or dizziness due to motion sickness."
},
{
"NDCCode": "75834-245-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-245-60) ",
"NDC11Code": "75834-0245-60",
"ProductNDC": "75834-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam Extended Release",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201464",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200916",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam Extended-Release Tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.",
"Description": "Levetiracetam Extended-Release Tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam Extended-Release Tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, ethylcellulose, magnesium stearate, microcrystalline cellulose and talc. The imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Contains no ingredients made from a gluten-containing grain (wheat, barley, or rye). The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "76420-245-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-245-60) ",
"NDC11Code": "76420-0245-60",
"ProductNDC": "76420-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201384",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2022-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220725",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use.",
"Description": "Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol. Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol."
},
{
"NDCCode": "76439-245-60",
"PackageDescription": "1 KIT in 1 CARTON (76439-245-60) * 30 TABLET in 1 BLISTER PACK * 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "76439-0245-60",
"ProductNDC": "76439-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Natalvirt 90dha",
"NonProprietaryName": "Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium, Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Iodine, Zinc, Copper, And Doconexent",
"DosageFormName": "KIT",
"StartMarketingDate": "20130115",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Virtus Pharmaceuticals",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "53217-001-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (53217-001-60)",
"NDC11Code": "53217-0001-60",
"ProductNDC": "53217-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040663",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Warfarin sodium tablets, USP are a vitamin K antagonist indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (1) , 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement (1) , 3 Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction (1) .",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following:. Warfarin sodium, USP is a white crystalline powder. It is very soluble in water. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and pregelatinized starch. Additionally each 1 mg tablet contains D&C red no. 6 barium lake, 2 mg tablet contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake, 2.5 mg tablet contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake, 3 mg tablet contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake, 4 mg tablet contains FD&C blue no. 1 aluminum lake, 5 mg tablet contains FD&C yellow no. 6 aluminum lake, 6 mg tablet contains FD&C yellow no. 6 aluminum lake and FD&C blue no. 1 aluminum lake, 7.5 mg tablet contains D&C yellow no. 10 aluminum lake and FD&C yellow no.6 aluminum lake and 10 mg tablet is dye free."
},
{
"NDCCode": "53217-003-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (53217-003-60)",
"NDC11Code": "53217-0003-60",
"ProductNDC": "53217-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074532",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hypertension: Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril, consideration should be given to the risk of neutropenia/ agranulocytosis (see WARNINGS). Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. Heart Failure: Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment. Left Ventricular Dysfunction After Myocardial Infarction: Captopril tablets are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients. Diabetic Nephropathy: Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis). In considering use of captopril tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline. Molecular formula C9H15NO3S [MW 217.29] and has the following structural formula. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each scored tablet, for oral administration, contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, anhydrous lactose, colloidal silicon dioxide, talc and palmitic acid."
},
{
"NDCCode": "53217-005-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (53217-005-60)",
"NDC11Code": "53217-0005-60",
"ProductNDC": "53217-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digox",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076268",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC],Cardiac Glycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(0-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-0-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: 0.250 mg - colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg - colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid."
},
{
"NDCCode": "53217-006-60",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53217-006-60)",
"NDC11Code": "53217-0006-60",
"ProductNDC": "53217-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090492",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules (Once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules (Once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, formic acid, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP (Once-a-day dosage) is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg, 300 mg, or 360 mg diltiazem hydrochloride, USP. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg contain: sugar spheres, hypromellose, talc, ethylcellulose, triethyl citrate, ammonio methacrylate copolymer dispersion type B, acetyl tributyl citrate, polysorbate 80, and magnesium stearate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue 1 and iron oxide black (180 mg, 240 mg, 300 mg and 360 mg). Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For oral administration. USP dissolution test pending."
},
{
"NDCCode": "53217-007-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53217-007-60)",
"NDC11Code": "53217-0007-60",
"ProductNDC": "53217-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040788",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticarial and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol - part. hydrolyzed, talc and titanium dioxide."
},
{
"NDCCode": "53217-010-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53217-010-60)",
"NDC11Code": "53217-0010-60",
"ProductNDC": "53217-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedicalxl",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20001211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075289",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Nifedical XL® tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedical XL® tablets may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers.",
"Description": "Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and 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. Each extended-release tablet, formulated as a once-a-day controlled release tablet for oral administration, delivers 30 or 60 mg of nifedipine. In addition, each extended-release tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type A, methacrylic acid copolymer type B, microcrystalline cellulose, polyethylene glycol, red ferric oxide, sodium lauryl sulfate, talc and titanium dioxide. Nifedipine Extended-release Tablets meet USP Dissolution Test 3."
},
{
"NDCCode": "53217-012-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (53217-012-60)",
"NDC11Code": "53217-0012-60",
"ProductNDC": "53217-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075743",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration."
},
{
"NDCCode": "53217-018-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (53217-018-60)",
"NDC11Code": "53217-0018-60",
"ProductNDC": "53217-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202202",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Warfarin sodium is indicated for: . Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.Limitations of Use Warfarin sodium tablets, USP have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.",
"Description": "Crystalline warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Warfarin sodium tablets, USP (Crystalline) for oral use also contain. : 1 All strengths: Hydroxypropyl Cellulose, Lactose Monohydrate, Magnesium Stearate and Pregelatinized Starch ."
},
{
"NDCCode": "53217-019-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53217-019-60)",
"NDC11Code": "53217-0019-60",
"ProductNDC": "53217-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4·HCl. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "53217-021-01",
"PackageDescription": "60 g in 1 TUBE (53217-021-01)",
"NDC11Code": "53217-0021-01",
"ProductNDC": "53217-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063211",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.",
"Description": "Erythromycin Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is C37H67NO13. It has the following structural formula. Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane. It is very poorly soluble in water. Each gram of Erythromycin Topical Gel USP, 2% contains 20 mg of erythromycin USP in a vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose."
},
{
"NDCCode": "53217-040-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (53217-040-60)",
"NDC11Code": "53217-0040-60",
"ProductNDC": "53217-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "37.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combine two analgesics, tramadol, USP 37.5 mg and acetaminophen, USP 325 mg. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablets are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Dissolution Method: Test 2."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>53217-245-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (53217-245-60)</PackageDescription>
<NDC11Code>53217-0245-60</NDC11Code>
<ProductNDC>53217-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078627</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. 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.Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>53217-245-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53217-245-30)</PackageDescription>
<NDC11Code>53217-0245-30</NDC11Code>
<ProductNDC>53217-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078627</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. 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.Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>53217-245-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (53217-245-90)</PackageDescription>
<NDC11Code>53217-0245-90</NDC11Code>
<ProductNDC>53217-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078627</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. 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.Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>24658-245-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (24658-245-60)</PackageDescription>
<NDC11Code>24658-0245-60</NDC11Code>
<ProductNDC>24658-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076063</ApplicationNumber>
<LabelerName>Blu Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>27808-245-01</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (27808-245-01) </PackageDescription>
<NDC11Code>27808-0245-01</NDC11Code>
<ProductNDC>27808-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208308</ApplicationNumber>
<LabelerName>Tris Pharma Inc</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>49999-245-60</NDCCode>
<PackageDescription>60 TABLET in 1 VIAL (49999-245-60)</PackageDescription>
<NDC11Code>49999-0245-60</NDC11Code>
<ProductNDC>49999-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090637</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>52686-245-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52686-245-60) > 33.45 g in 1 TUBE</PackageDescription>
<NDC11Code>52686-0245-60</NDC11Code>
<ProductNDC>52686-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Perfect Refining Foundation</ProprietaryName>
<ProprietaryNameSuffix>O60</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICA INC.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.63555; 1.37145</StrengthNumber>
<StrengthUnit>g/33.45g; g/33.45g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52959-245-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (52959-245-60)</PackageDescription>
<NDC11Code>52959-0245-60</NDC11Code>
<ProductNDC>52959-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoprofen</ProprietaryName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073516</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketoprofen capsules and other treatment options before deciding to use ketoprofen capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules are indicated for the management of pain. Ketoprofen capsules are also indicated for treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. C16H14O3 M.W. 254.29. It has a pKa of 5.94 in methanol: water (3:1) and an n-octanol: water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Ketoprofen capsules contain 50 mg or 75 mg of ketoprofen for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>59088-245-06</NDCCode>
<PackageDescription>60 g in 1 JAR (59088-245-06) </PackageDescription>
<NDC11Code>59088-0245-06</NDC11Code>
<ProductNDC>59088-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methylten 25%</ProprietaryName>
<ProprietaryNameSuffix>Pain Relieving</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61919-245-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-245-60) </PackageDescription>
<NDC11Code>61919-0245-60</NDC11Code>
<ProductNDC>61919-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091269</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Short-Term Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer. [See Clinical Studies (14)] 1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole delayed-release capsules /amoxicillin /clarithromycinLansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See Clinical Studies (14)] Please refer to the full prescribing information for amoxicillin and clarithromycin.Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin Dual Therapy: Lansoprazole delayed-release capsules /amoxicillinLansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See Clinical Studies (14)] Please refer to the full prescribing information for amoxicillin.1.3 Maintenance of Healed Duodenal Ulcers Lansoprazole delayed-release capsules are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14)] 1.4 Short-Term Treatment of Active Benign Gastric Ulcer Lansoprazole delayed-release capsules are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer. [See Clinical Studies (14)] 1.5 Healing of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks. [See Clinical Studies (14)] 1.6 Risk Reduction of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules are indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. [See Clinical Studies (14)] 1.7 Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERDLansoprazole delayed-release capsules is indicated for the treatment of heartburn and other symptoms associated with GERD for upto 8 weeks. [See Clinical Studies (14)] Short-Term Treatment of Erosive EsophagitisLansoprazole delayed-release capsules is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of lansoprazole delayed-release capsules may be considered. [See Clinical Studies (14)] 1.8 Maintenance of Healing of Erosive Esophagitis (EE) Lansoprazole delayed-release capsules are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. [See Clinical Studies (14)] 1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) Lansoprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. [See Clinical Studies (14)] .</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamideand practically insoluble in water. Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole USP is supplied as delayed-release capsules. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.</Description>
</NDC>
<NDC>
<NDCCode>67544-245-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (67544-245-60) </PackageDescription>
<NDC11Code>67544-0245-60</NDC11Code>
<ProductNDC>67544-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011217</StartMarketingDate>
<EndMarketingDate>20210531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075636</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040817</StartMarketingDatePackage>
<EndMarketingDatePackage>20210531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-245-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68462-245-60)</PackageDescription>
<NDC11Code>68462-0245-60</NDC11Code>
<ProductNDC>68462-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090169</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69539-245-34</NDCCode>
<PackageDescription>60 TABLET in 1 BOX (69539-245-34) </PackageDescription>
<NDC11Code>69539-0245-34</NDC11Code>
<ProductNDC>69539-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asenapine</ProprietaryName>
<NonProprietaryName>Asenapine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20210827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205960</ApplicationNumber>
<LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
<SubstanceName>ASENAPINE MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Asenapine sublingual tablets are indicated for: 1 Schizophrenia in adults [see Clinical Studies (14.1)], 2 Bipolar I disorder [see Clinical Studies (14.2)]Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of ageAdjunctive treatment to lithium or valproate in adultsMaintenance monotherapy treatment in adults.</IndicationAndUsage>
<Description>Asenapine sublingual tablets contain asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is(3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole(2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO.C4H4O4 and its molecular weight is 401.84 (free base: 285.8). The chemical structure is. Asenapine maleate is a white to off-white powder. Asenapine sublingual tablets (Unflavored) are supplied for sublingual administration in tablets containing 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone. Asenapine sublingual tablets, black cherry flavor, are supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone and black cherry flavor (components are nature identical flavorings, natural flavoring substances, natural flavoring complexes, maize maltodextrin and moisture).</Description>
</NDC>
<NDC>
<NDCCode>69865-245-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69865-245-02) </PackageDescription>
<NDC11Code>69865-0245-02</NDC11Code>
<ProductNDC>69865-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucynta</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200533</ApplicationNumber>
<LabelerName>Depo NF Sub, LLC</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NUCYNTA ER (tapentadol) is indicated for the management of: 1 pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, 2 neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.</IndicationAndUsage>
<Description>NUCYNTA ER (tapentadol) is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n- octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>71205-245-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (71205-245-60) </PackageDescription>
<NDC11Code>71205-0245-60</NDC11Code>
<ProductNDC>71205-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090170</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine Tablets are indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. It's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&C Blue No. 2 Lake.</Description>
</NDC>
<NDC>
<NDCCode>71610-245-60</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (71610-245-60) </PackageDescription>
<NDC11Code>71610-0245-60</NDC11Code>
<ProductNDC>71610-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rugby Travel Sickness</ProprietaryName>
<ProprietaryNameSuffix>Meclizine Hcl, 25 Mg Each (antiemetic)</ProprietaryNameSuffix>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140819</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part336</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses prevents and treats nausea, vomiting or dizziness due to motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75834-245-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-245-60) </PackageDescription>
<NDC11Code>75834-0245-60</NDC11Code>
<ProductNDC>75834-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam Extended Release</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201464</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam Extended-Release Tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.</IndicationAndUsage>
<Description>Levetiracetam Extended-Release Tablets are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam Extended-Release Tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, ethylcellulose, magnesium stearate, microcrystalline cellulose and talc. The imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Contains no ingredients made from a gluten-containing grain (wheat, barley, or rye). The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>76420-245-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-245-60) </PackageDescription>
<NDC11Code>76420-0245-60</NDC11Code>
<ProductNDC>76420-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201384</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use.</IndicationAndUsage>
<Description>Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol. Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>76439-245-60</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76439-245-60) * 30 TABLET in 1 BLISTER PACK * 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>76439-0245-60</NDC11Code>
<ProductNDC>76439-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Natalvirt 90dha</ProprietaryName>
<NonProprietaryName>Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium, Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Iodine, Zinc, Copper, And Doconexent</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Virtus Pharmaceuticals</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>53217-001-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (53217-001-60)</PackageDescription>
<NDC11Code>53217-0001-60</NDC11Code>
<ProductNDC>53217-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040663</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Warfarin sodium tablets, USP are a vitamin K antagonist indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (1) , 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement (1) , 3 Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction (1) .</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following:. Warfarin sodium, USP is a white crystalline powder. It is very soluble in water. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and pregelatinized starch. Additionally each 1 mg tablet contains D&C red no. 6 barium lake, 2 mg tablet contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake, 2.5 mg tablet contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake, 3 mg tablet contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake, 4 mg tablet contains FD&C blue no. 1 aluminum lake, 5 mg tablet contains FD&C yellow no. 6 aluminum lake, 6 mg tablet contains FD&C yellow no. 6 aluminum lake and FD&C blue no. 1 aluminum lake, 7.5 mg tablet contains D&C yellow no. 10 aluminum lake and FD&C yellow no.6 aluminum lake and 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>53217-003-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (53217-003-60)</PackageDescription>
<NDC11Code>53217-0003-60</NDC11Code>
<ProductNDC>53217-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril</ProprietaryName>
<NonProprietaryName>Captopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074532</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hypertension: Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril, consideration should be given to the risk of neutropenia/ agranulocytosis (see WARNINGS). Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. Heart Failure: Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment. Left Ventricular Dysfunction After Myocardial Infarction: Captopril tablets are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients. Diabetic Nephropathy: Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis). In considering use of captopril tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline. Molecular formula C9H15NO3S [MW 217.29] and has the following structural formula. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each scored tablet, for oral administration, contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, anhydrous lactose, colloidal silicon dioxide, talc and palmitic acid.</Description>
</NDC>
<NDC>
<NDCCode>53217-005-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (53217-005-60)</PackageDescription>
<NDC11Code>53217-0005-60</NDC11Code>
<ProductNDC>53217-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digox</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076268</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC],Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(0-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-0-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: 0.250 mg - colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg - colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>53217-006-60</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53217-006-60)</PackageDescription>
<NDC11Code>53217-0006-60</NDC11Code>
<ProductNDC>53217-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090492</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules (Once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules (Once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, formic acid, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP (Once-a-day dosage) is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg, 300 mg, or 360 mg diltiazem hydrochloride, USP. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg contain: sugar spheres, hypromellose, talc, ethylcellulose, triethyl citrate, ammonio methacrylate copolymer dispersion type B, acetyl tributyl citrate, polysorbate 80, and magnesium stearate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue 1 and iron oxide black (180 mg, 240 mg, 300 mg and 360 mg). Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For oral administration. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>53217-007-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53217-007-60)</PackageDescription>
<NDC11Code>53217-0007-60</NDC11Code>
<ProductNDC>53217-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040788</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticarial and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol - part. hydrolyzed, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53217-010-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53217-010-60)</PackageDescription>
<NDC11Code>53217-0010-60</NDC11Code>
<ProductNDC>53217-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedicalxl</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075289</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals 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>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nifedical XL® tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedical XL® tablets may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers.</IndicationAndUsage>
<Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and 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. Each extended-release tablet, formulated as a once-a-day controlled release tablet for oral administration, delivers 30 or 60 mg of nifedipine. In addition, each extended-release tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type A, methacrylic acid copolymer type B, microcrystalline cellulose, polyethylene glycol, red ferric oxide, sodium lauryl sulfate, talc and titanium dioxide. Nifedipine Extended-release Tablets meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>53217-012-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (53217-012-60)</PackageDescription>
<NDC11Code>53217-0012-60</NDC11Code>
<ProductNDC>53217-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075743</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>53217-018-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (53217-018-60)</PackageDescription>
<NDC11Code>53217-0018-60</NDC11Code>
<ProductNDC>53217-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202202</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Warfarin sodium is indicated for: . Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.Limitations of Use Warfarin sodium tablets, USP have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.</IndicationAndUsage>
<Description>Crystalline warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Warfarin sodium tablets, USP (Crystalline) for oral use also contain. : 1 All strengths: Hydroxypropyl Cellulose, Lactose Monohydrate, Magnesium Stearate and Pregelatinized Starch .</Description>
</NDC>
<NDC>
<NDCCode>53217-019-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53217-019-60)</PackageDescription>
<NDC11Code>53217-0019-60</NDC11Code>
<ProductNDC>53217-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4·HCl. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53217-021-01</NDCCode>
<PackageDescription>60 g in 1 TUBE (53217-021-01)</PackageDescription>
<NDC11Code>53217-0021-01</NDC11Code>
<ProductNDC>53217-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063211</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Erythromycin Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is C37H67NO13. It has the following structural formula. Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane. It is very poorly soluble in water. Each gram of Erythromycin Topical Gel USP, 2% contains 20 mg of erythromycin USP in a vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose.</Description>
</NDC>
<NDC>
<NDCCode>53217-040-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (53217-040-60)</PackageDescription>
<NDC11Code>53217-0040-60</NDC11Code>
<ProductNDC>53217-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090485</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>37.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablets, USP combine two analgesics, tramadol, USP 37.5 mg and acetaminophen, USP 325 mg. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablets are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Dissolution Method: Test 2.</Description>
</NDC>
</NDCList>