{
"NDC": [
{
"NDCCode": "49884-250-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-01) ",
"NDC11Code": "49884-0250-01",
"ProductNDC": "49884-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine And Fluoxetine",
"NonProprietaryName": "Olanzapine And Fuoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20121126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077742",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "6; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49884-006-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (49884-006-04) / 250 g in 1 BOTTLE",
"NDC11Code": "49884-0006-04",
"ProductNDC": "49884-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phenylbutyrate",
"NonProprietaryName": "Sodium Phenylbutyrate",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20160831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203918",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "SODIUM PHENYLBUTYRATE",
"StrengthNumber": ".94",
"StrengthUnit": "g/g",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160831",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phenylbutyrate powder is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to improve survival. Any episode of acute hyperammonemia should be treated as a life-threatening emergency. Sodium phenylbutyrate powder must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (See Nutritional Supplementation subsection of the DOSAGE AND ADMINISTRATION section.). Previously, neonatal-onset disease was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogs. However, with hemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate, and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth but within the first month of life is almost 80%. Most deaths have occurred during an episode of acute hyperammonemic encephalopathy. Patients with neonatal-onset disease have a high incidence of mental retardation. Those who had IQ tests administered had an incidence of mental retardation as follows: ornithine transcarbamylase deficiency, 100% (14/14 patients tested); argininosuccinic acid synthetase deficiency, 88% (15/17 patients tested); and carbamylphosphate synthetase deficiency, 57% (4/7 patients tested). Retardation was severe in the majority of the retarded patients. In patients diagnosed during gestation and treated prior to any episode of hyperammonemic encephalopathy, survival is 100%, but even in these patients, most subsequently demonstrate cognitive impairment or other neurologic deficits. In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recover from hyperammonemic encephalopathy and are then treated chronically with sodium phenylbutyrate and dietary protein restriction, the survival rate is 98%. The two deaths in this group of patients occurred during episodes of hyperammonemic encephalopathy. However, compliance with the therapeutic regimen has not been adequately documented to allow evaluation of the potential for sodium phenylbutyrate powder and dietary protein restriction to prevent mental deterioration and recurrence of hyperammonemic encephalopathy if carefully adhered to. The majority of these patients tested (30/46 or 65%) have IQ's in the average to low average/borderline mentally retarded range. Reversal of pre-existing neurologic impairment is not likely to occur with treatment and neurologic deterioration may continue in some patients. Even on therapy, acute hyperammonemic encephalopathy recurred in the majority of patients for whom the drug is indicated. Sodium phenylbutyrate powder may be required life-long unless orthotopic liver transplantation is elected. (See CLINICAL PHARMACOLOGY, Pharmacodynamics subsection for the biochemical effects of sodium phenylbutyrate powder).",
"Description": "Sodium phenylbutyrate powder, USP nasogastric, or gastrostomy tube administration contain Sodium Phenylbutyrate, USP. Sodium phenylbutyrate powder is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium phenylbutyrate, USP also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C10H11O2Na. Chemical Structure. Each gram of Sodium phenylbutyrate powder, USP contains 0.94 grams of Sodium phenylbutyrate, USP and the inactive ingredients calcium stearate NF and colloidal silicon dioxide NF."
},
{
"NDCCode": "49884-093-04",
"PackageDescription": "250 TABLET in 1 BOTTLE (49884-093-04) ",
"NDC11Code": "49884-0093-04",
"ProductNDC": "49884-093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001215",
"EndMarketingDate": "20200831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065070",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20001215",
"EndMarketingDatePackage": "20200831",
"SamplePackage": "N"
},
{
"NDCCode": "49884-170-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (49884-170-04) / 250 TABLET in 1 BOTTLE",
"NDC11Code": "49884-0170-04",
"ProductNDC": "49884-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phenylbutyrate",
"NonProprietaryName": "Sodium Phenylbutyrate Tablets, 500 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204395",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "SODIUM PHENYLBUTYRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160429",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Phenylbutyrate Tablets is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to improve survival. Any episode of acute hyperammonemia should be treated as a life-threatening emergency. Sodium Phenylbutyrate Tablets must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (See Nutritional Supplementation subsection of the DOSAGE AND ADMINISTRATION section.). Previously, neonatal-onset disease was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogs. However, with hemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate, and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth but within the first month of life is almost 80%. Most deaths have occurred during an episode of acute hyperammonemic encephalopathy. Patients with neonatal-onset disease have a high incidence of mental retardation. Those who had IQ tests administered had an incidence of mental retardation as follows: ornithine transcarbamylase deficiency, 100% (14/14 patients tested); argininosuccinic acid synthetase deficiency, 88% (15/17 patients tested); and carbamylphosphate synthetase deficiency, 57% (4/7 patients tested). Retardation was severe in the majority of the retarded patients. In patients diagnosed during gestation and treated prior to any episode of hyperammonemic encephalopathy, survival is 100%, but even in these patients, most subsequently demonstrate cognitive impairment or other neurologic deficits. In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recover from hyperammonemic encephalopathy and are then treated chronically with Sodium Phenylbutyrate Tablets and dietary protein restriction, the survival rate is 98%. The two deaths in this group of patients occurred during episodes of hyperammonemic encephalopathy. However, compliance with the therapeutic regimen has not been adequately documented to allow evaluation of the potential for Sodium Phenylbutyrate Tablets and dietary protein restriction to prevent mental deterioration and recurrence of hyperammonemic encephalopathy if carefully adhered to. The majority of these patients tested (30/46 or 65%) have IQ's in the average to low average/borderline mentally retarded range. Reversal of pre-existing neurologic impairment is not likely to occur with treatment and neurologic deterioration may continue in some patients. Even on therapy, acute hyperammonemic encephalopathy recurred in the majority of patients for whom the drug is indicated. Sodium Phenylbutyrate Tablets may be required life-long unless orthotopic liver transplantation is elected. (See CLINICAL PHARMACOLOGY, Pharmacodynamics subsection for the biochemical effects of Sodium Phenylbutyrate Tablets).",
"Description": "Sodium Phenylbutyrate Tablets, USP for oral administration contain Sodium phenylbutyrate, USP. Sodium Phenylbutyrate, USP is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium Phenylbutyrate, USP also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C10H11O2Na. Chemical Structure. Each tablet of Sodium Phenylbutyrate Tablets USP contains 500 mg of Sodium Phenylbutyrate, USP and the inactive ingredients calcium stearate NF, colloidal silicon dioxide NF, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "49884-250-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-10) ",
"NDC11Code": "49884-0250-10",
"ProductNDC": "49884-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine And Fluoxetine",
"NonProprietaryName": "Olanzapine And Fuoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20121126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077742",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "6; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49884-250-11",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-11) ",
"NDC11Code": "49884-0250-11",
"ProductNDC": "49884-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine And Fluoxetine",
"NonProprietaryName": "Olanzapine And Fuoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20121126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077742",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "6; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121126",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].",
"Description": "Olanzapine and Fluoxetine Capsules, USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H- thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol."
},
{
"NDCCode": "49884-290-04",
"PackageDescription": "250 TABLET in 1 BOTTLE (49884-290-04) ",
"NDC11Code": "49884-0290-04",
"ProductNDC": "49884-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880808",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072423",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19880808",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch."
},
{
"NDCCode": "49884-545-04",
"PackageDescription": "250 TABLET in 1 BOTTLE (49884-545-04)",
"NDC11Code": "49884-0545-04",
"ProductNDC": "49884-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075180",
"LabelerName": "Par Pharmaceutical Inc",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49884-727-04",
"PackageDescription": "250 CAPSULE in 1 BOTTLE (49884-727-04) ",
"NDC11Code": "49884-0727-04",
"ProductNDC": "49884-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20001201",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065055",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20001201",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules USP and other antibacterial drugs, doxycycline capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline Capsules USP is indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline Capsules USP is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline Capsules USP is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline Capsules USP is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.",
"Description": "Doxycycline Capsules USP is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg and 50 mg capsules contain doxycycline monohydrate equivalent to 150 mg, 100 mg or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. M.W. = 462.45. Doxycycline Capsules USP has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients include colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and titanium dioxide. In addition, the 50 mg strength contains FD&C Yellow #6 and D&C Yellow #10. The 100 mg strength also contains black iron oxide, red iron oxide and yellow iron oxide. The 150 mg strength includes FD&C Red #40 and FD&C Yellow #6."
},
{
"NDCCode": "49884-922-04",
"PackageDescription": "250 TABLET in 1 BOTTLE (49884-922-04)",
"NDC11Code": "49884-0922-04",
"ProductNDC": "49884-922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mercaptopurine",
"NonProprietaryName": "Mercaptopurine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040461",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "MERCAPTOPURINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-04-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Mercaptopurine tablets are indicated for maintenance therapy of acute lymphatic (lymphocytic, lymphoblastic) leukemia as part of a combination regimen. The response to this agent depends upon the particular subclassification of acute lymphatic leukemia and the age of the patient (pediatric or adult). Mercaptopurine is not effective for prophylaxis or treatment of central nervous system leukemia. Mercaptopurine is not effective in acute myelogenous leukemia, chronic lymphatic leukemia, the lymphomas (including Hodgkins Disease), or solid tumors.",
"Description": "Mercaptopurine was synthesized and developed by Hitchings, Elion, and associates at the Wellcome Research Laboratories. Mercaptopurine, known chemically as 1,7-dihydro-6H-purine-6-thione monohydrate, is an analogue of the purine bases adenine and hypoxanthine. Its structural formula is:. Mercaptopurine is available in tablet form for oral administration. Each scored tablet contains 50 mg mercaptopurine and the inactive ingredients microcrystalline cellulose NF, lactose monohydrate NF, stearic acid NF, and colloidal silicon dioxide NF. Mercaptopurine Tablets USP meet USP Dissolution Test 2."
},
{
"NDCCode": "49884-009-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-009-01) ",
"NDC11Code": "49884-0009-01",
"ProductNDC": "49884-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087946",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19830210",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. C6H8N208 MW 236.14. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1."
},
{
"NDCCode": "49884-020-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-020-01) ",
"NDC11Code": "49884-0020-01",
"ProductNDC": "49884-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19791213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086923",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19791213",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. C6H8N208 MW 236.14. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1."
},
{
"NDCCode": "49884-021-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-021-01) ",
"NDC11Code": "49884-0021-01",
"ProductNDC": "49884-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19791222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086925",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19791222",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. C6H8N208 MW 236.14. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1."
},
{
"NDCCode": "49884-022-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-022-01) ",
"NDC11Code": "49884-0022-01",
"ProductNDC": "49884-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19811215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087537",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19811215",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. C6H8N208 MW 236.14. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1."
},
{
"NDCCode": "49884-027-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-027-01) ",
"NDC11Code": "49884-0027-01",
"ProductNDC": "49884-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19800227",
"EndMarketingDate": "20180430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086961",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "49884-028-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-028-01) ",
"NDC11Code": "49884-0028-01",
"ProductNDC": "49884-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19800227",
"EndMarketingDate": "20180430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086962",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "49884-029-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-029-01) ",
"NDC11Code": "49884-0029-01",
"ProductNDC": "49884-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19821005",
"EndMarketingDate": "20180430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087836",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "49884-032-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (49884-032-01) ",
"NDC11Code": "49884-0032-01",
"ProductNDC": "49884-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranylcypromine Sulfate",
"NonProprietaryName": "Tranylcypromine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060630",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040640",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "TRANYLCYPROMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060630",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Tranylcypromine Sulfate is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine Sulfate is not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7)].",
"Description": "Tranylcypromine sulfate, the active ingredient of Tranylcypromine Sulfate Tablets USP, is a non-hydrazine MAOI. The chemical name is (±)‑trans‑2‑phenylcyclopropylamine sulfate (2:1). The molecular formula is (C9H11N)2H2SO4 and its molecular weight is 364.46. The structural formula is. Tranylcypromine Sulfate film-coated tablets are intended for oral administration. Each round, dark pink tablet is debossed with “250” on one side and “K” on the other side and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, talc, and Opadry® II pink 85F14289. Opadry pink is used for purposed of coating and contains the following: FD&C Red # 40, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "49884-034-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-034-01) ",
"NDC11Code": "49884-0034-01",
"ProductNDC": "49884-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087127",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19810603",
"SamplePackage": "N"
},
{
"NDCCode": "49884-035-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-035-01) ",
"NDC11Code": "49884-0035-01",
"ProductNDC": "49884-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087128",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19810603",
"SamplePackage": "N"
},
{
"NDCCode": "49884-038-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (49884-038-01) ",
"NDC11Code": "49884-0038-01",
"ProductNDC": "49884-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenoxybenzamine Hydrochloride",
"NonProprietaryName": "Phenoxybenzamine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204522",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "PHENOXYBENZAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170124",
"SamplePackage": "N",
"IndicationAndUsage": "Phenoxybenzamine hydrochloride capsules, USP is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta-blocking agent concomitantly.",
"Description": "Each Phenoxybenzamine hydrochloride capsule, USP contains 10 mg of phenoxybenzamine hydrochloride, USP. Inactive ingredients consist of lactose anhydrous and talc. Phenoxybenzamine hydrochloride is N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl) benzylamine hydrochloride:. Phenoxybenzamine hydrochloride is a white solid crystalline powder with a molecular weight of 340.3, which melts between 136° and 141°C. It is freely soluble in methanol, soluble in acetone, insoluble in ethyl acetate. USP Organic Impurities Test pending."
},
{
"NDCCode": "49884-043-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-043-01)",
"NDC11Code": "49884-0043-01",
"ProductNDC": "49884-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087129",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "49884-048-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-048-01) ",
"NDC11Code": "49884-0048-01",
"ProductNDC": "49884-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202842",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170105",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].",
"Description": "Dexmethylphenidate hydrochloride extended-release contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is intended for oral administration and is available as 5 mg, 10 mg, 20 mg, 25 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: methacrylic acid copolymer, amino methacrylate copolymer, triethyl citrate, talc, sugar spheres, polyethylene glycol, gelatin, titanium dioxide and black ink. The black ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40 and D&C Yellow #10. The 5 mg also contains FD& C Blue #1 and FD&C Red #3. The 10 mg contains FD&C Yellow #6. The 25 mg, 35 mg and 40 mg contains yellow iron oxide."
},
{
"NDCCode": "49884-049-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-049-01) ",
"NDC11Code": "49884-0049-01",
"ProductNDC": "49884-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202842",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170105",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].",
"Description": "Dexmethylphenidate hydrochloride extended-release contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is intended for oral administration and is available as 5 mg, 10 mg, 20 mg, 25 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: methacrylic acid copolymer, amino methacrylate copolymer, triethyl citrate, talc, sugar spheres, polyethylene glycol, gelatin, titanium dioxide and black ink. The black ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40 and D&C Yellow #10. The 5 mg also contains FD& C Blue #1 and FD&C Red #3. The 10 mg contains FD&C Yellow #6. The 25 mg, 35 mg and 40 mg contains yellow iron oxide."
},
{
"NDCCode": "49884-054-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-054-01) ",
"NDC11Code": "49884-0054-01",
"ProductNDC": "49884-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19831021",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088292",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19831101",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis: May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.",
"Description": "Imipramine hydrochloride, USP is supplied in tablet form for oral administration. Imipramine hydrochloride, USP the original tricyclic antidepressant is a member of the dibenzazepine group of compounds. It is designated 5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride. Its structural formula is. C19 H24 N2●HCl MW: 316.87. Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless, or practically odorless, crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Imipramine hydrochloride tablets, USP are available for oral administration providing 10 mg, 25 mg or 50 mg of imipramine hydrochloride. Inactive ingredients: FD&C Yellow #6, hydroxypropyl cellulose, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, titanium dioxide and triacetin. In addition, the 10 mg tablet contains D&C Yellow #10; the 25 mg tablet contains FD&C Red #40 and FD&C Blue #2; the 50 mg tablet contains D&C Yellow #10 and FD&C Blue #1."
},
{
"NDCCode": "49884-055-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-055-01) ",
"NDC11Code": "49884-0055-01",
"ProductNDC": "49884-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19831021",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088262",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19831101",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis: May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.",
"Description": "Imipramine hydrochloride, USP is supplied in tablet form for oral administration. Imipramine hydrochloride, USP the original tricyclic antidepressant is a member of the dibenzazepine group of compounds. It is designated 5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride. Its structural formula is. C19 H24 N2●HCl MW: 316.87. Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless, or practically odorless, crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Imipramine hydrochloride tablets, USP are available for oral administration providing 10 mg, 25 mg or 50 mg of imipramine hydrochloride. Inactive ingredients: FD&C Yellow #6, hydroxypropyl cellulose, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, titanium dioxide and triacetin. In addition, the 10 mg tablet contains D&C Yellow #10; the 25 mg tablet contains FD&C Red #40 and FD&C Blue #2; the 50 mg tablet contains D&C Yellow #10 and FD&C Blue #1."
},
{
"NDCCode": "49884-056-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-056-01) ",
"NDC11Code": "49884-0056-01",
"ProductNDC": "49884-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19831021",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088276",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19831101",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis: May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.",
"Description": "Imipramine hydrochloride, USP is supplied in tablet form for oral administration. Imipramine hydrochloride, USP the original tricyclic antidepressant is a member of the dibenzazepine group of compounds. It is designated 5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride. Its structural formula is. C19 H24 N2●HCl MW: 316.87. Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless, or practically odorless, crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Imipramine hydrochloride tablets, USP are available for oral administration providing 10 mg, 25 mg or 50 mg of imipramine hydrochloride. Inactive ingredients: FD&C Yellow #6, hydroxypropyl cellulose, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, titanium dioxide and triacetin. In addition, the 10 mg tablet contains D&C Yellow #10; the 25 mg tablet contains FD&C Red #40 and FD&C Blue #2; the 50 mg tablet contains D&C Yellow #10 and FD&C Blue #1."
},
{
"NDCCode": "49884-060-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (49884-060-01) ",
"NDC11Code": "49884-0060-01",
"ProductNDC": "49884-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trientine Hydrochloride",
"NonProprietaryName": "Trientine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190927",
"EndMarketingDate": "20270531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210096",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "TRIENTINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Copper Chelating Activity [MoA], Copper Chelator [EPC], Metal Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190927",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, trientine hydrochloride capsules are not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride capsules was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.",
"Description": "Trientine hydrochloride is N,N'-bis (2-aminoethyl)-1,2-ethanediamine dihydrochloride. It is a white to pale yellow crystalline hygroscopic powder. It is freely soluble in water, soluble in methanol, slightly soluble in ethanol, and insoluble in chloroform and ether. The empirical formula is C6H18N42HCl with a molecular weight of 219.2. The structural formula is. NH2(CH2)2NH(CH2)2NH(CH2)2NH22HCl. Trientine hydrochloride is a chelating compound for removal of excess copper from the body. Trientine hydrochloride is available as 250 mg capsules for oral administration. Trientine hydrochloride capsules USP, 250 mg contain stearic acid. In addition, the empty hard gelatin capsule shells contain gelatin, iron oxide black, iron oxide red, iron oxide yellow and titanium dioxide. The capsule shells are imprinted with TEK black ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "49884-065-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-065-01) ",
"NDC11Code": "49884-0065-01",
"ProductNDC": "49884-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040653",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060926",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use. Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.33 g/mol, and the structural formula is. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate."
},
{
"NDCCode": "49884-066-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-066-01) ",
"NDC11Code": "49884-0066-01",
"ProductNDC": "49884-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040653",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060926",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use. Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.33 g/mol, and the structural formula is. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49884-250-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-01) </PackageDescription>
<NDC11Code>49884-0250-01</NDC11Code>
<ProductNDC>49884-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fuoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077742</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-006-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49884-006-04) / 250 g in 1 BOTTLE</PackageDescription>
<NDC11Code>49884-0006-04</NDC11Code>
<ProductNDC>49884-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phenylbutyrate</ProprietaryName>
<NonProprietaryName>Sodium Phenylbutyrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203918</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>SODIUM PHENYLBUTYRATE</SubstanceName>
<StrengthNumber>.94</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phenylbutyrate powder is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to improve survival. Any episode of acute hyperammonemia should be treated as a life-threatening emergency. Sodium phenylbutyrate powder must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (See Nutritional Supplementation subsection of the DOSAGE AND ADMINISTRATION section.). Previously, neonatal-onset disease was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogs. However, with hemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate, and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth but within the first month of life is almost 80%. Most deaths have occurred during an episode of acute hyperammonemic encephalopathy. Patients with neonatal-onset disease have a high incidence of mental retardation. Those who had IQ tests administered had an incidence of mental retardation as follows: ornithine transcarbamylase deficiency, 100% (14/14 patients tested); argininosuccinic acid synthetase deficiency, 88% (15/17 patients tested); and carbamylphosphate synthetase deficiency, 57% (4/7 patients tested). Retardation was severe in the majority of the retarded patients. In patients diagnosed during gestation and treated prior to any episode of hyperammonemic encephalopathy, survival is 100%, but even in these patients, most subsequently demonstrate cognitive impairment or other neurologic deficits. In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recover from hyperammonemic encephalopathy and are then treated chronically with sodium phenylbutyrate and dietary protein restriction, the survival rate is 98%. The two deaths in this group of patients occurred during episodes of hyperammonemic encephalopathy. However, compliance with the therapeutic regimen has not been adequately documented to allow evaluation of the potential for sodium phenylbutyrate powder and dietary protein restriction to prevent mental deterioration and recurrence of hyperammonemic encephalopathy if carefully adhered to. The majority of these patients tested (30/46 or 65%) have IQ's in the average to low average/borderline mentally retarded range. Reversal of pre-existing neurologic impairment is not likely to occur with treatment and neurologic deterioration may continue in some patients. Even on therapy, acute hyperammonemic encephalopathy recurred in the majority of patients for whom the drug is indicated. Sodium phenylbutyrate powder may be required life-long unless orthotopic liver transplantation is elected. (See CLINICAL PHARMACOLOGY, Pharmacodynamics subsection for the biochemical effects of sodium phenylbutyrate powder).</IndicationAndUsage>
<Description>Sodium phenylbutyrate powder, USP nasogastric, or gastrostomy tube administration contain Sodium Phenylbutyrate, USP. Sodium phenylbutyrate powder is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium phenylbutyrate, USP also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C10H11O2Na. Chemical Structure. Each gram of Sodium phenylbutyrate powder, USP contains 0.94 grams of Sodium phenylbutyrate, USP and the inactive ingredients calcium stearate NF and colloidal silicon dioxide NF.</Description>
</NDC>
<NDC>
<NDCCode>49884-093-04</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (49884-093-04) </PackageDescription>
<NDC11Code>49884-0093-04</NDC11Code>
<ProductNDC>49884-093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001215</StartMarketingDate>
<EndMarketingDate>20200831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065070</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20001215</StartMarketingDatePackage>
<EndMarketingDatePackage>20200831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49884-170-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49884-170-04) / 250 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>49884-0170-04</NDC11Code>
<ProductNDC>49884-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phenylbutyrate</ProprietaryName>
<NonProprietaryName>Sodium Phenylbutyrate Tablets, 500 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204395</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>SODIUM PHENYLBUTYRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Phenylbutyrate Tablets is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to improve survival. Any episode of acute hyperammonemia should be treated as a life-threatening emergency. Sodium Phenylbutyrate Tablets must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (See Nutritional Supplementation subsection of the DOSAGE AND ADMINISTRATION section.). Previously, neonatal-onset disease was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogs. However, with hemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate, and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth but within the first month of life is almost 80%. Most deaths have occurred during an episode of acute hyperammonemic encephalopathy. Patients with neonatal-onset disease have a high incidence of mental retardation. Those who had IQ tests administered had an incidence of mental retardation as follows: ornithine transcarbamylase deficiency, 100% (14/14 patients tested); argininosuccinic acid synthetase deficiency, 88% (15/17 patients tested); and carbamylphosphate synthetase deficiency, 57% (4/7 patients tested). Retardation was severe in the majority of the retarded patients. In patients diagnosed during gestation and treated prior to any episode of hyperammonemic encephalopathy, survival is 100%, but even in these patients, most subsequently demonstrate cognitive impairment or other neurologic deficits. In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recover from hyperammonemic encephalopathy and are then treated chronically with Sodium Phenylbutyrate Tablets and dietary protein restriction, the survival rate is 98%. The two deaths in this group of patients occurred during episodes of hyperammonemic encephalopathy. However, compliance with the therapeutic regimen has not been adequately documented to allow evaluation of the potential for Sodium Phenylbutyrate Tablets and dietary protein restriction to prevent mental deterioration and recurrence of hyperammonemic encephalopathy if carefully adhered to. The majority of these patients tested (30/46 or 65%) have IQ's in the average to low average/borderline mentally retarded range. Reversal of pre-existing neurologic impairment is not likely to occur with treatment and neurologic deterioration may continue in some patients. Even on therapy, acute hyperammonemic encephalopathy recurred in the majority of patients for whom the drug is indicated. Sodium Phenylbutyrate Tablets may be required life-long unless orthotopic liver transplantation is elected. (See CLINICAL PHARMACOLOGY, Pharmacodynamics subsection for the biochemical effects of Sodium Phenylbutyrate Tablets).</IndicationAndUsage>
<Description>Sodium Phenylbutyrate Tablets, USP for oral administration contain Sodium phenylbutyrate, USP. Sodium Phenylbutyrate, USP is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium Phenylbutyrate, USP also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C10H11O2Na. Chemical Structure. Each tablet of Sodium Phenylbutyrate Tablets USP contains 500 mg of Sodium Phenylbutyrate, USP and the inactive ingredients calcium stearate NF, colloidal silicon dioxide NF, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>49884-250-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-10) </PackageDescription>
<NDC11Code>49884-0250-10</NDC11Code>
<ProductNDC>49884-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fuoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077742</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-250-11</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-11) </PackageDescription>
<NDC11Code>49884-0250-11</NDC11Code>
<ProductNDC>49884-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fuoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077742</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Olanzapine and Fluoxetine Capsules, USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H- thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>49884-290-04</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (49884-290-04) </PackageDescription>
<NDC11Code>49884-0290-04</NDC11Code>
<ProductNDC>49884-290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880808</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072423</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880808</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>49884-545-04</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (49884-545-04)</PackageDescription>
<NDC11Code>49884-0545-04</NDC11Code>
<ProductNDC>49884-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075180</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49884-727-04</NDCCode>
<PackageDescription>250 CAPSULE in 1 BOTTLE (49884-727-04) </PackageDescription>
<NDC11Code>49884-0727-04</NDC11Code>
<ProductNDC>49884-727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001201</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065055</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20001201</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules USP and other antibacterial drugs, doxycycline capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline Capsules USP is indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline Capsules USP is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline Capsules USP is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline Capsules USP is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.</IndicationAndUsage>
<Description>Doxycycline Capsules USP is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg and 50 mg capsules contain doxycycline monohydrate equivalent to 150 mg, 100 mg or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. M.W. = 462.45. Doxycycline Capsules USP has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients include colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and titanium dioxide. In addition, the 50 mg strength contains FD&C Yellow #6 and D&C Yellow #10. The 100 mg strength also contains black iron oxide, red iron oxide and yellow iron oxide. The 150 mg strength includes FD&C Red #40 and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>49884-922-04</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (49884-922-04)</PackageDescription>
<NDC11Code>49884-0922-04</NDC11Code>
<ProductNDC>49884-922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mercaptopurine</ProprietaryName>
<NonProprietaryName>Mercaptopurine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040461</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>MERCAPTOPURINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-30</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Mercaptopurine tablets are indicated for maintenance therapy of acute lymphatic (lymphocytic, lymphoblastic) leukemia as part of a combination regimen. The response to this agent depends upon the particular subclassification of acute lymphatic leukemia and the age of the patient (pediatric or adult). Mercaptopurine is not effective for prophylaxis or treatment of central nervous system leukemia. Mercaptopurine is not effective in acute myelogenous leukemia, chronic lymphatic leukemia, the lymphomas (including Hodgkins Disease), or solid tumors.</IndicationAndUsage>
<Description>Mercaptopurine was synthesized and developed by Hitchings, Elion, and associates at the Wellcome Research Laboratories. Mercaptopurine, known chemically as 1,7-dihydro-6H-purine-6-thione monohydrate, is an analogue of the purine bases adenine and hypoxanthine. Its structural formula is:. Mercaptopurine is available in tablet form for oral administration. Each scored tablet contains 50 mg mercaptopurine and the inactive ingredients microcrystalline cellulose NF, lactose monohydrate NF, stearic acid NF, and colloidal silicon dioxide NF. Mercaptopurine Tablets USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>49884-009-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-009-01) </PackageDescription>
<NDC11Code>49884-0009-01</NDC11Code>
<ProductNDC>49884-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087946</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. C6H8N208 MW 236.14. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>49884-020-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-020-01) </PackageDescription>
<NDC11Code>49884-0020-01</NDC11Code>
<ProductNDC>49884-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19791213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086923</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19791213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. C6H8N208 MW 236.14. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>49884-021-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-021-01) </PackageDescription>
<NDC11Code>49884-0021-01</NDC11Code>
<ProductNDC>49884-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19791222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086925</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19791222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. C6H8N208 MW 236.14. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>49884-022-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-022-01) </PackageDescription>
<NDC11Code>49884-0022-01</NDC11Code>
<ProductNDC>49884-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087537</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. C6H8N208 MW 236.14. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>49884-027-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-027-01) </PackageDescription>
<NDC11Code>49884-0027-01</NDC11Code>
<ProductNDC>49884-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19800227</StartMarketingDate>
<EndMarketingDate>20180430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086961</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>49884-028-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-028-01) </PackageDescription>
<NDC11Code>49884-0028-01</NDC11Code>
<ProductNDC>49884-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19800227</StartMarketingDate>
<EndMarketingDate>20180430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086962</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</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>2018-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>49884-029-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-029-01) </PackageDescription>
<NDC11Code>49884-0029-01</NDC11Code>
<ProductNDC>49884-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821005</StartMarketingDate>
<EndMarketingDate>20180430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087836</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>49884-032-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (49884-032-01) </PackageDescription>
<NDC11Code>49884-0032-01</NDC11Code>
<ProductNDC>49884-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranylcypromine Sulfate</ProprietaryName>
<NonProprietaryName>Tranylcypromine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060630</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040640</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>TRANYLCYPROMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060630</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranylcypromine Sulfate is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine Sulfate is not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7)].</IndicationAndUsage>
<Description>Tranylcypromine sulfate, the active ingredient of Tranylcypromine Sulfate Tablets USP, is a non-hydrazine MAOI. The chemical name is (±)‑trans‑2‑phenylcyclopropylamine sulfate (2:1). The molecular formula is (C9H11N)2H2SO4 and its molecular weight is 364.46. The structural formula is. Tranylcypromine Sulfate film-coated tablets are intended for oral administration. Each round, dark pink tablet is debossed with “250” on one side and “K” on the other side and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, talc, and Opadry® II pink 85F14289. Opadry pink is used for purposed of coating and contains the following: FD&C Red # 40, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49884-034-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-034-01) </PackageDescription>
<NDC11Code>49884-0034-01</NDC11Code>
<ProductNDC>49884-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087127</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC],Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49884-035-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-035-01) </PackageDescription>
<NDC11Code>49884-0035-01</NDC11Code>
<ProductNDC>49884-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087128</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</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>2021-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49884-038-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (49884-038-01) </PackageDescription>
<NDC11Code>49884-0038-01</NDC11Code>
<ProductNDC>49884-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenoxybenzamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenoxybenzamine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204522</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>PHENOXYBENZAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenoxybenzamine hydrochloride capsules, USP is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta-blocking agent concomitantly.</IndicationAndUsage>
<Description>Each Phenoxybenzamine hydrochloride capsule, USP contains 10 mg of phenoxybenzamine hydrochloride, USP. Inactive ingredients consist of lactose anhydrous and talc. Phenoxybenzamine hydrochloride is N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl) benzylamine hydrochloride:. Phenoxybenzamine hydrochloride is a white solid crystalline powder with a molecular weight of 340.3, which melts between 136° and 141°C. It is freely soluble in methanol, soluble in acetone, insoluble in ethyl acetate. USP Organic Impurities Test pending.</Description>
</NDC>
<NDC>
<NDCCode>49884-043-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-043-01)</PackageDescription>
<NDC11Code>49884-0043-01</NDC11Code>
<ProductNDC>49884-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087129</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-12-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>49884-048-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-048-01) </PackageDescription>
<NDC11Code>49884-0048-01</NDC11Code>
<ProductNDC>49884-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202842</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is intended for oral administration and is available as 5 mg, 10 mg, 20 mg, 25 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: methacrylic acid copolymer, amino methacrylate copolymer, triethyl citrate, talc, sugar spheres, polyethylene glycol, gelatin, titanium dioxide and black ink. The black ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40 and D&C Yellow #10. The 5 mg also contains FD& C Blue #1 and FD&C Red #3. The 10 mg contains FD&C Yellow #6. The 25 mg, 35 mg and 40 mg contains yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>49884-049-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-049-01) </PackageDescription>
<NDC11Code>49884-0049-01</NDC11Code>
<ProductNDC>49884-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202842</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is intended for oral administration and is available as 5 mg, 10 mg, 20 mg, 25 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: methacrylic acid copolymer, amino methacrylate copolymer, triethyl citrate, talc, sugar spheres, polyethylene glycol, gelatin, titanium dioxide and black ink. The black ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40 and D&C Yellow #10. The 5 mg also contains FD& C Blue #1 and FD&C Red #3. The 10 mg contains FD&C Yellow #6. The 25 mg, 35 mg and 40 mg contains yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>49884-054-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-054-01) </PackageDescription>
<NDC11Code>49884-0054-01</NDC11Code>
<ProductNDC>49884-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19831021</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088292</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19831101</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis: May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.</IndicationAndUsage>
<Description>Imipramine hydrochloride, USP is supplied in tablet form for oral administration. Imipramine hydrochloride, USP the original tricyclic antidepressant is a member of the dibenzazepine group of compounds. It is designated 5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride. Its structural formula is. C19 H24 N2●HCl MW: 316.87. Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless, or practically odorless, crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Imipramine hydrochloride tablets, USP are available for oral administration providing 10 mg, 25 mg or 50 mg of imipramine hydrochloride. Inactive ingredients: FD&C Yellow #6, hydroxypropyl cellulose, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, titanium dioxide and triacetin. In addition, the 10 mg tablet contains D&C Yellow #10; the 25 mg tablet contains FD&C Red #40 and FD&C Blue #2; the 50 mg tablet contains D&C Yellow #10 and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>49884-055-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-055-01) </PackageDescription>
<NDC11Code>49884-0055-01</NDC11Code>
<ProductNDC>49884-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19831021</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088262</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19831101</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis: May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.</IndicationAndUsage>
<Description>Imipramine hydrochloride, USP is supplied in tablet form for oral administration. Imipramine hydrochloride, USP the original tricyclic antidepressant is a member of the dibenzazepine group of compounds. It is designated 5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride. Its structural formula is. C19 H24 N2●HCl MW: 316.87. Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless, or practically odorless, crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Imipramine hydrochloride tablets, USP are available for oral administration providing 10 mg, 25 mg or 50 mg of imipramine hydrochloride. Inactive ingredients: FD&C Yellow #6, hydroxypropyl cellulose, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, titanium dioxide and triacetin. In addition, the 10 mg tablet contains D&C Yellow #10; the 25 mg tablet contains FD&C Red #40 and FD&C Blue #2; the 50 mg tablet contains D&C Yellow #10 and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>49884-056-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-056-01) </PackageDescription>
<NDC11Code>49884-0056-01</NDC11Code>
<ProductNDC>49884-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19831021</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088276</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19831101</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis: May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.</IndicationAndUsage>
<Description>Imipramine hydrochloride, USP is supplied in tablet form for oral administration. Imipramine hydrochloride, USP the original tricyclic antidepressant is a member of the dibenzazepine group of compounds. It is designated 5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride. Its structural formula is. C19 H24 N2●HCl MW: 316.87. Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless, or practically odorless, crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Imipramine hydrochloride tablets, USP are available for oral administration providing 10 mg, 25 mg or 50 mg of imipramine hydrochloride. Inactive ingredients: FD&C Yellow #6, hydroxypropyl cellulose, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, titanium dioxide and triacetin. In addition, the 10 mg tablet contains D&C Yellow #10; the 25 mg tablet contains FD&C Red #40 and FD&C Blue #2; the 50 mg tablet contains D&C Yellow #10 and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>49884-060-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (49884-060-01) </PackageDescription>
<NDC11Code>49884-0060-01</NDC11Code>
<ProductNDC>49884-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trientine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trientine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190927</StartMarketingDate>
<EndMarketingDate>20270531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210096</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>TRIENTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Copper Chelating Activity [MoA], Copper Chelator [EPC], Metal Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190927</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, trientine hydrochloride capsules are not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride capsules was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.</IndicationAndUsage>
<Description>Trientine hydrochloride is N,N'-bis (2-aminoethyl)-1,2-ethanediamine dihydrochloride. It is a white to pale yellow crystalline hygroscopic powder. It is freely soluble in water, soluble in methanol, slightly soluble in ethanol, and insoluble in chloroform and ether. The empirical formula is C6H18N42HCl with a molecular weight of 219.2. The structural formula is. NH2(CH2)2NH(CH2)2NH(CH2)2NH22HCl. Trientine hydrochloride is a chelating compound for removal of excess copper from the body. Trientine hydrochloride is available as 250 mg capsules for oral administration. Trientine hydrochloride capsules USP, 250 mg contain stearic acid. In addition, the empty hard gelatin capsule shells contain gelatin, iron oxide black, iron oxide red, iron oxide yellow and titanium dioxide. The capsule shells are imprinted with TEK black ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>49884-065-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-065-01) </PackageDescription>
<NDC11Code>49884-0065-01</NDC11Code>
<ProductNDC>49884-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040653</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use. Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.33 g/mol, and the structural formula is. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>49884-066-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-066-01) </PackageDescription>
<NDC11Code>49884-0066-01</NDC11Code>
<ProductNDC>49884-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040653</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use. Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.33 g/mol, and the structural formula is. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.</Description>
</NDC>
</NDCList>