{
"NDC": [
{
"NDCCode": "42291-655-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-655-56)",
"NDC11Code": "42291-0655-56",
"ProductNDC": "42291-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine And Fluoxetine",
"NonProprietaryName": "Olanzapine And Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077528",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE; OLANZAPINE",
"StrengthNumber": "25; 12",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-07-21"
},
{
"NDCCode": "42291-655-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-655-30) ",
"NDC11Code": "42291-0655-30",
"ProductNDC": "42291-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine And Fluoxetine",
"NonProprietaryName": "Olanzapine And Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077528",
"LabelerName": "AvKARE",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "12; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140121",
"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 combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa ®, and Zyprexa ® Zydis ®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac ®, Prozac ® Weekly , and Sarafem ®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP 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 chemical structures are. C 17H 20N 4S M.W. 312.44. C 17H 18F 3NOHCl M.W. 345.79. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride, USP 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 also contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C yellow #10 and FD&C yellow #6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C red #28, FD&C blue #1, and FD&C red #40."
},
{
"NDCCode": "21130-655-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-655-56) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "21130-0655-56",
"ProductNDC": "21130-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20150301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150301",
"SamplePackage": "N"
},
{
"NDCCode": "50844-655-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (50844-655-56) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "50844-0655-56",
"ProductNDC": "50844-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20150301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "L.N.K. International, Inc.",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150301",
"SamplePackage": "N"
},
{
"NDCCode": "42291-718-56",
"PackageDescription": "56 CAPSULE in 1 BOTTLE (42291-718-56)",
"NDC11Code": "42291-0718-56",
"ProductNDC": "42291-718",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076277",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "42291-927-56",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (42291-927-56) ",
"NDC11Code": "42291-0927-56",
"ProductNDC": "42291-927",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214557",
"LabelerName": "AvKARE",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230914",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablet is indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13H 13N 3 C 4H 6O 6. The chemical structure is: Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with \"VC\" on one side and \"0.5\" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with \"VC\" on one side and \"1\" on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide, triacetin. Additionally, FD & C blue # 1, FD & C blue #2, talc, yellow iron oxide are present in 1 mg strength."
},
{
"NDCCode": "42291-928-56",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (42291-928-56) ",
"NDC11Code": "42291-0928-56",
"ProductNDC": "42291-928",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214557",
"LabelerName": "AvKARE",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230914",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablet is indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13H 13N 3 C 4H 6O 6. The chemical structure is: Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with \"VC\" on one side and \"0.5\" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with \"VC\" on one side and \"1\" on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide, triacetin. Additionally, FD & C blue # 1, FD & C blue #2, talc, yellow iron oxide are present in 1 mg strength."
},
{
"NDCCode": "42291-043-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42291-043-60) ",
"NDC11Code": "42291-0043-60",
"ProductNDC": "42291-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065368",
"LabelerName": "AvKARE",
"SubstanceName": "CEFDINIR",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240613",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6 R,7 R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below:. C 14H 13N 5O 5S 2M.W. 395.41. Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "42291-048-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-048-30) ",
"NDC11Code": "42291-0048-30",
"ProductNDC": "42291-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208008",
"LabelerName": "AvKARE",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white solid that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride USP, equivalent to 0.5 mg of fingolimod. Each capsule contains the following inactive ingredients: pregelatinized starch (corn) and sodium lauryl sulfate. The capsule shell contains gelatin, iron oxide yellow, and titanium dioxide. In addition, the imprinting ink contains the following: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "42291-310-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42291-310-01) ",
"NDC11Code": "42291-0310-01",
"ProductNDC": "42291-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Guanfacine Hydrochloride",
"NonProprietaryName": "Guanfacine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075109",
"LabelerName": "AvKARE",
"SubstanceName": "GUANFACINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210702",
"SamplePackage": "N",
"IndicationAndUsage": "Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Guanfacine hydrochloride, USP is a centrally acting antihypertensive with α 2 -adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride, USP is N-amidino-2-(2,6-dichlorophenyl) acetamide hydrochloride and its molecular weight is 282.56. Its structural formula is. Guanfacine hydrochloride, USP is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone. Each tablet, for oral administration, contains guanfacine hydrochloride, USP equivalent to 1 mg or 2 mg guanfacine. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, and stearic acid."
},
{
"NDCCode": "42291-713-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-713-30) ",
"NDC11Code": "42291-0713-30",
"ProductNDC": "42291-713",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090869",
"LabelerName": "AvKARE",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3."
},
{
"NDCCode": "42291-714-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-714-30) ",
"NDC11Code": "42291-0714-30",
"ProductNDC": "42291-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090869",
"LabelerName": "AvKARE",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3."
},
{
"NDCCode": "42291-715-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-715-30) ",
"NDC11Code": "42291-0715-30",
"ProductNDC": "42291-715",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090869",
"LabelerName": "AvKARE",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3."
},
{
"NDCCode": "42291-716-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-716-30) ",
"NDC11Code": "42291-0716-30",
"ProductNDC": "42291-716",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090869",
"LabelerName": "AvKARE",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3."
},
{
"NDCCode": "42291-717-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-717-30) ",
"NDC11Code": "42291-0717-30",
"ProductNDC": "42291-717",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090869",
"LabelerName": "AvKARE",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3."
},
{
"NDCCode": "42291-780-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42291-780-30) ",
"NDC11Code": "42291-0780-30",
"ProductNDC": "42291-780",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rasagiline",
"NonProprietaryName": "Rasagiline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210520",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021641",
"LabelerName": "AvKARE",
"SubstanceName": "RASAGILINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210520",
"SamplePackage": "N",
"IndicationAndUsage": "Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD).",
"Description": "Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The empirical formula of rasagiline mesylate is C 12H 13NCH 4SO 3 and its molecular weight is 267.34. Its structural formula is. Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate). Each rasagiline tablet also contains the following inactive ingredients: mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid, and talc."
},
{
"NDCCode": "42291-931-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01) ",
"NDC11Code": "42291-0931-01",
"ProductNDC": "42291-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ursodiol",
"NonProprietaryName": "Ursodiol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202540",
"LabelerName": "AvKARE",
"SubstanceName": "URSODIOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid [EPC], Bile Acids and Salts [CS]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231214",
"SamplePackage": "N",
"IndicationAndUsage": "Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC).",
"Description": "Ursodiol Tablets, USP 250 mg are available as a film-coated tablet for oral administration. Ursodiol Tablets, USP 500 mg are available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of ursodiol is 3α,7ß-dihydroxy-5ß-cholan-24-oic (C 24H 40O 4). Ursodiol has a molecular weight of 392.56. Its structure is shown below. Inactive ingredients: caprylic/capric triglycerides, copovidone, hypromellose, microcrystalline cellulose, magnesium stearate, povidone, polydextrose, polyethylene glycol 3350, sodium starch glycolate type A and titanium dioxide."
},
{
"NDCCode": "10019-655-06",
"PackageDescription": "6 BOTTLE in 1 CARTON (10019-655-06) / 250 mL in 1 BOTTLE",
"NDC11Code": "10019-0655-06",
"ProductNDC": "10019-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevoflurane",
"NonProprietaryName": "Sevoflurane",
"DosageFormName": "LIQUID",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20020702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075895",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "SEVOFLURANE",
"StrengthNumber": "250",
"StrengthUnit": "mL/250mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220726",
"SamplePackage": "N",
"IndicationAndUsage": "Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.",
"Description": "Sevoflurane, USP, volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane, USP is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl) ethyl ether and its structural formula is. Sevoflurane, USP is nonflammable and nonexplosive as defined by the requirements of International Electrotechnical Commission 601-2-13. Sevoflurane, USP is a clear, colorless, liquid containing no additives. Sevoflurane, USP is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass or copper beryllium. Sevoflurane, USP is nonpungent. It is miscible with ethanol, ether, chloroform, and benzene, and it is slightly soluble in water. Sevoflurane, USP is stable when stored under normal room lighting conditions according to instructions. No discernible degradation of sevoflurane, USP occurs in the presence of strong acids or heat. When in contact with alkaline CO2 absorbents (e.g., Baralyme® and to a lesser extent soda lime) within the anesthesia machine, Sevoflurane, USP can undergo degradation under certain conditions. Degradation of sevoflurane, USP is minimal, and degradants are either undetectable or present in non-toxic amounts when used as directed with fresh absorbents. Sevoflurane, USP degradation and subsequent degradant formation are enhanced by increasing absorbent temperature increased sevoflurane, USP concentration, decreased fresh gas flow and desiccated CO2 absorbents (especially with potassium hydroxide containing absorbents e.g., Baralyme). Sevoflurane, USP alkaline degradation occurs by two pathways. The first results from the loss of hydrogen fluoride with the formation of pentafluoroisopropenyl fluoromethyl ether, (PIFE, C4H2F6O), also known as Compound A, and trace amounts of pentafluoromethoxy isopropyl fluoromethyl ether, (PMFE, C5H6F6O), also known as Compound B. The second pathway for degradation of sevoflurane, USP, which occurs primarily in the presence of desiccated CO2 absorbents, is discussed later. In the first pathway, the defluorination pathway, the production of degradants in the anesthesia circuit results from the extraction of the acidic proton in the presence of a strong base (KOH and/or NaOH) forming an alkene (Compound A) from sevoflurane, USP similar to formation of 2-bromo-2-chloro-1,1-difluoro ethylene (BCDFE) from halothane. Laboratory simulations have shown that the concentration of these degradants is inversely correlated with the fresh gas flow rate (See Figure 1). Since the reaction of carbon dioxide with absorbents is exothermic, the temperature increase will be determined by quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anesthesia circle system, metabolic status of the patient, and ventilation. The relationship of temperature produced by varying levels of CO2 and Compound A production is illustrated in the following in vitro simulation where CO2 was added to a circle absorber system. Compound A concentration in a circle absorber system increases as a function of increasing CO2 absorbent temperature and composition (Baralyme producing higher levels than soda lime), increased body temperature, and increased minute ventilation, and decreasing fresh gas flow rates. It has been reported that the concentration of Compound A increases significantly with prolonged dehydration of Baralyme. Compound A exposure in patients also has been shown to rise with increased sevoflurane, USP concentrations and duration of anesthesia. In a clinical study in which sevoflurane, USP was administered to patients under low flow conditions for ≥ 2 hours at flow rates of 1 Liter/minute, Compound A levels were measured in an effort to determine the relationship between MAC hours and Compound A levels produced. The relationship between Compound A levels and sevoflurane, USP exposure are shown in Figure 2a. Compound A has been shown to be nephrotoxic in rats after exposures that have varied in duration from one to three hours. No histopathologic change was seen at a concentration of up to 270 ppm for one hour. Sporadic single cell necrosis of proximal tubule cells has been reported at a concentration of 114 ppm after a 3-hour exposure to Compound A in rats. The LC50 reported at 1 hour is 1050-1090 ppm (male-female) and, at 3 hours, 350-490 ppm (male-female). An experiment was performed comparing sevoflurane, USP plus 75 or 100 ppm Compound A with an active control to evaluate the potential nephrotoxicity of Compound A in non-human primates. A single 8-hour exposure of Sevoflurane, USP in the presence of Compound A produced single-cell renal tubular degeneration and single-cell necrosis in cynomolgus monkeys. These changes are consistent with the increased urinary protein, glucose level and enzymic activity noted on days one and three on the clinical pathology evaluation. This nephrotoxicity produced by Compound A is dose and duration of exposure dependent. At a fresh gas flow rate of 1 L/min, mean maximum concentrations of Compound A in the anesthesia circuit in clinical settings are approximately 20 ppm (0.002%) with soda lime and 30 ppm (0.003%) with Baralyme in adult patients; mean maximum concentrations in pediatric patients with soda lime are about half those found in adults. The highest concentration observed in a single patient with Baralyme was 61 ppm (0.0061%) and 32 ppm (0.0032%) with soda lime. The levels of Compound A at which toxicity occurs in humans is not known. The second pathway for degradation of sevoflurane, USP occurs primarily in the presence of desiccated CO2 absorbents and leads to the dissociation of sevoflurane, USP into hexafluoroisopropanol (HFIP) and formaldehyde. HFIP is inactive, non-genotoxic, rapidly glucuronidated and cleared by the liver. Formaldehyde is present during normal metabolic processes. Upon exposure to a highly desiccated absorbent, formaldehyde can further degrade into methanol and formate. Formate can contribute to the formation of carbon monoxide in the presence of high temperature that can be associated with desiccated Baralyme®. Methanol can react with Compound A to form the methoxy addition product Compound B. Compound B can undergo further HF elimination to form Compounds C, D, and E. Sevoflurane, USP degradants were observed in the respiratory circuit of an experimental anesthesia machine using desiccated CO2 absorbents and maximum sevoflurane, USP concentrations (8%) for extended periods of time (˃ 2 hours). Concentrations of formaldehyde observed with desiccated soda lime in this experimental anesthesia respiratory circuit were consistent with levels that could potentially result in respiratory irritation. Although KOH containing CO2 absorbents are no longer commercially available, in the laboratory experiments, exposure of sevoflurane, USP to the desiccated KOH containing CO2 absorbent, Baralyme, resulted in the detection of substantially greater degradant levels."
},
{
"NDCCode": "10135-655-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-655-01) ",
"NDC11Code": "10135-0655-01",
"ProductNDC": "10135-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206505",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC],Sulfones [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white to yellow crystalline powder. Sparingly soluble in alcohol; Soluble in acetone and in dilute mineral acids; practically insoluble in water. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose. USP Dissolution Test Pending."
},
{
"NDCCode": "10135-655-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10135-655-30) ",
"NDC11Code": "10135-0655-30",
"ProductNDC": "10135-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206505",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC],Sulfones [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white to yellow crystalline powder. Sparingly soluble in alcohol; Soluble in acetone and in dilute mineral acids; practically insoluble in water. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose. USP Dissolution Test Pending."
},
{
"NDCCode": "10237-655-09",
"PackageDescription": "1 TUBE in 1 CARTON (10237-655-09) / 25 g in 1 TUBE",
"NDC11Code": "10237-0655-09",
"ProductNDC": "10237-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peroxicare",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20120129",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260607",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental decay."
},
{
"NDCCode": "10237-655-12",
"PackageDescription": "2 TUBE in 1 CARTON (10237-655-12) / 170 g in 1 TUBE",
"NDC11Code": "10237-0655-12",
"ProductNDC": "10237-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peroxicare",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20120129",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120129",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental decay."
},
{
"NDCCode": "10237-655-46",
"PackageDescription": "4 CARTON in 1 PACKAGE (10237-655-46) / 1 TUBE in 1 CARTON / 170 g in 1 TUBE",
"NDC11Code": "10237-0655-46",
"ProductNDC": "10237-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peroxicare",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20120129",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental decay."
},
{
"NDCCode": "10237-655-60",
"PackageDescription": "1 TUBE in 1 CARTON (10237-655-60) / 170 g in 1 TUBE",
"NDC11Code": "10237-0655-60",
"ProductNDC": "10237-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peroxicare",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20120129",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120129",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental decay."
},
{
"NDCCode": "10237-655-72",
"PackageDescription": "1 TUBE in 1 CARTON (10237-655-72) > 204 g in 1 TUBE",
"NDC11Code": "10237-0655-72",
"ProductNDC": "10237-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peroxie Care Tartar Control",
"ProprietaryNameSuffix": "Healthy Gums Baking Soda And Peroxide",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20120129",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "13537-655-08",
"PackageDescription": "1 TUBE in 1 BOX (13537-655-08) > 3.8 g in 1 TUBE (13537-655-07)",
"NDC11Code": "13537-0655-08",
"ProductNDC": "13537-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Multi-gloss Dual With Triple Gloss Effect Spf 15",
"ProprietaryNameSuffix": "(rubi) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150326",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".07",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. ."
},
{
"NDCCode": "15127-655-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (15127-655-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "15127-0655-10",
"ProductNDC": "15127-655",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20150301",
"EndMarketingDate": "20210910",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "L&R Distributors, Inc.",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150301",
"EndMarketingDatePackage": "20210910",
"SamplePackage": "N"
},
{
"NDCCode": "16571-655-06",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (16571-655-06) ",
"NDC11Code": "16571-0655-06",
"ProductNDC": "16571-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zafirlukast",
"NonProprietaryName": "Zafirlukast Tablets",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204928",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ZAFIRLUKAST",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220825",
"SamplePackage": "N",
"IndicationAndUsage": "Zafirlukast Tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.",
"Description": "Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is:. The empirical formula is: C31H33N3O6S. Zafirlukast, an off white to light pink color powder, is practically insoluble in water. It is freely soluble in tetrahydrofuran, dimethylsulfoxide and acetone. Zafirlukast Tablets are supplied as 10 and 20 mg tablets for oral administration."
},
{
"NDCCode": "16714-655-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16714-655-01) ",
"NDC11Code": "16714-0655-01",
"ProductNDC": "16714-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170126",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078627",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170126",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "21695-655-20",
"PackageDescription": "1 TUBE in 1 CARTON (21695-655-20) > 20 g in 1 TUBE",
"NDC11Code": "21695-0655-20",
"ProductNDC": "21695-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19981224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075264",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tretinoin gel and cream are indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Each gram of tretinoin gel contains tretinoin in either of two strengths, 0.025% (0.25 mg) or 0.01% (0.1 mg) in a gel vehicle of hydroxypropyl cellulose, butylated hydroxytoluene, and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Each gram of tretinoin cream contains tretinoin in either of three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025% (0.25 mg) in a hydrophilic cream vehicle of: stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid. It has a molecular weight of 300.44 and has the following structural formula."
}
]
}
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<NDCList>
<NDC>
<NDCCode>42291-655-56</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42291-655-56)</PackageDescription>
<NDC11Code>42291-0655-56</NDC11Code>
<ProductNDC>42291-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077528</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE; OLANZAPINE</SubstanceName>
<StrengthNumber>25; 12</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>2014-07-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-655-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42291-655-30) </PackageDescription>
<NDC11Code>42291-0655-30</NDC11Code>
<ProductNDC>42291-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077528</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12; 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>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140121</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 combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa ®, and Zyprexa ® Zydis ®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac ®, Prozac ® Weekly , and Sarafem ®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP 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 chemical structures are. C 17H 20N 4S M.W. 312.44. C 17H 18F 3NOHCl M.W. 345.79. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride, USP 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 also contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C yellow #10 and FD&C yellow #6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C red #28, FD&C blue #1, and FD&C red #40.</Description>
</NDC>
<NDC>
<NDCCode>21130-655-56</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-655-56) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0655-56</NDC11Code>
<ProductNDC>21130-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50844-655-56</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50844-655-56) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>50844-0655-56</NDC11Code>
<ProductNDC>50844-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>L.N.K. International, Inc.</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-718-56</NDCCode>
<PackageDescription>56 CAPSULE in 1 BOTTLE (42291-718-56)</PackageDescription>
<NDC11Code>42291-0718-56</NDC11Code>
<ProductNDC>42291-718</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ribavirin</ProprietaryName>
<NonProprietaryName>Ribavirin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076277</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>RIBAVIRIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-927-56</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (42291-927-56) </PackageDescription>
<NDC11Code>42291-0927-56</NDC11Code>
<ProductNDC>42291-927</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214557</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablet is indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13H 13N 3 C 4H 6O 6. The chemical structure is: Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "VC" on one side and "0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "VC" on one side and "1" on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide, triacetin. Additionally, FD & C blue # 1, FD & C blue #2, talc, yellow iron oxide are present in 1 mg strength.</Description>
</NDC>
<NDC>
<NDCCode>42291-928-56</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (42291-928-56) </PackageDescription>
<NDC11Code>42291-0928-56</NDC11Code>
<ProductNDC>42291-928</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214557</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablet is indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13H 13N 3 C 4H 6O 6. The chemical structure is: Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "VC" on one side and "0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "VC" on one side and "1" on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide, triacetin. Additionally, FD & C blue # 1, FD & C blue #2, talc, yellow iron oxide are present in 1 mg strength.</Description>
</NDC>
<NDC>
<NDCCode>42291-043-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (42291-043-60) </PackageDescription>
<NDC11Code>42291-0043-60</NDC11Code>
<ProductNDC>42291-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065368</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CEFDINIR</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6 R,7 R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below:. C 14H 13N 5O 5S 2M.W. 395.41. Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-048-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42291-048-30) </PackageDescription>
<NDC11Code>42291-0048-30</NDC11Code>
<ProductNDC>42291-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fingolimod</ProprietaryName>
<NonProprietaryName>Fingolimod</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208008</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
<Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white solid that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride USP, equivalent to 0.5 mg of fingolimod. Each capsule contains the following inactive ingredients: pregelatinized starch (corn) and sodium lauryl sulfate. The capsule shell contains gelatin, iron oxide yellow, and titanium dioxide. In addition, the imprinting ink contains the following: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-310-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42291-310-01) </PackageDescription>
<NDC11Code>42291-0310-01</NDC11Code>
<ProductNDC>42291-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Guanfacine Hydrochloride</ProprietaryName>
<NonProprietaryName>Guanfacine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075109</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Guanfacine hydrochloride, USP is a centrally acting antihypertensive with α 2 -adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride, USP is N-amidino-2-(2,6-dichlorophenyl) acetamide hydrochloride and its molecular weight is 282.56. Its structural formula is. Guanfacine hydrochloride, USP is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone. Each tablet, for oral administration, contains guanfacine hydrochloride, USP equivalent to 1 mg or 2 mg guanfacine. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>42291-713-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-713-30) </PackageDescription>
<NDC11Code>42291-0713-30</NDC11Code>
<ProductNDC>42291-713</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090869</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>42291-714-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-714-30) </PackageDescription>
<NDC11Code>42291-0714-30</NDC11Code>
<ProductNDC>42291-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090869</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>42291-715-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-715-30) </PackageDescription>
<NDC11Code>42291-0715-30</NDC11Code>
<ProductNDC>42291-715</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090869</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>42291-716-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-716-30) </PackageDescription>
<NDC11Code>42291-0716-30</NDC11Code>
<ProductNDC>42291-716</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090869</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>42291-717-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-717-30) </PackageDescription>
<NDC11Code>42291-0717-30</NDC11Code>
<ProductNDC>42291-717</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090869</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole Extended-Release Tablets, USP contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243º to 250ºC and a solubility of 133 mg/mL in water. Each Ropinirole Extended-Release Tablet, USP for oral administration is oval-shaped and contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride, USP equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, and titanium dioxide. In addition the 2 mg tablet also contains iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. The 4 mg tablet also contains black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, polydextrose, polyethylene glycol, and triacetin. The 6 mg tablet also contains polyethylene glycol, polyvinyl-alcohol, and talc. The 8 mg tablet also contains iron oxide red, polyethylene glycol, polyvinyl-alcohol, and talc. The 12 mg tablet also contains iron oxide yellow, polyethylene glycol, polyvinyl-alcohol, and talc. This drug product conforms to USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>42291-780-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42291-780-30) </PackageDescription>
<NDC11Code>42291-0780-30</NDC11Code>
<ProductNDC>42291-780</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasagiline</ProprietaryName>
<NonProprietaryName>Rasagiline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210520</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021641</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>RASAGILINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD).</IndicationAndUsage>
<Description>Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The empirical formula of rasagiline mesylate is C 12H 13NCH 4SO 3 and its molecular weight is 267.34. Its structural formula is. Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate). Each rasagiline tablet also contains the following inactive ingredients: mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid, and talc.</Description>
</NDC>
<NDC>
<NDCCode>42291-931-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01) </PackageDescription>
<NDC11Code>42291-0931-01</NDC11Code>
<ProductNDC>42291-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ursodiol</ProprietaryName>
<NonProprietaryName>Ursodiol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202540</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid [EPC], Bile Acids and Salts [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC).</IndicationAndUsage>
<Description>Ursodiol Tablets, USP 250 mg are available as a film-coated tablet for oral administration. Ursodiol Tablets, USP 500 mg are available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of ursodiol is 3α,7ß-dihydroxy-5ß-cholan-24-oic (C 24H 40O 4). Ursodiol has a molecular weight of 392.56. Its structure is shown below. Inactive ingredients: caprylic/capric triglycerides, copovidone, hypromellose, microcrystalline cellulose, magnesium stearate, povidone, polydextrose, polyethylene glycol 3350, sodium starch glycolate type A and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10019-655-06</NDCCode>
<PackageDescription>6 BOTTLE in 1 CARTON (10019-655-06) / 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10019-0655-06</NDC11Code>
<ProductNDC>10019-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevoflurane</ProprietaryName>
<NonProprietaryName>Sevoflurane</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20020702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075895</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>SEVOFLURANE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.</IndicationAndUsage>
<Description>Sevoflurane, USP, volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane, USP is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl) ethyl ether and its structural formula is. Sevoflurane, USP is nonflammable and nonexplosive as defined by the requirements of International Electrotechnical Commission 601-2-13. Sevoflurane, USP is a clear, colorless, liquid containing no additives. Sevoflurane, USP is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass or copper beryllium. Sevoflurane, USP is nonpungent. It is miscible with ethanol, ether, chloroform, and benzene, and it is slightly soluble in water. Sevoflurane, USP is stable when stored under normal room lighting conditions according to instructions. No discernible degradation of sevoflurane, USP occurs in the presence of strong acids or heat. When in contact with alkaline CO2 absorbents (e.g., Baralyme® and to a lesser extent soda lime) within the anesthesia machine, Sevoflurane, USP can undergo degradation under certain conditions. Degradation of sevoflurane, USP is minimal, and degradants are either undetectable or present in non-toxic amounts when used as directed with fresh absorbents. Sevoflurane, USP degradation and subsequent degradant formation are enhanced by increasing absorbent temperature increased sevoflurane, USP concentration, decreased fresh gas flow and desiccated CO2 absorbents (especially with potassium hydroxide containing absorbents e.g., Baralyme). Sevoflurane, USP alkaline degradation occurs by two pathways. The first results from the loss of hydrogen fluoride with the formation of pentafluoroisopropenyl fluoromethyl ether, (PIFE, C4H2F6O), also known as Compound A, and trace amounts of pentafluoromethoxy isopropyl fluoromethyl ether, (PMFE, C5H6F6O), also known as Compound B. The second pathway for degradation of sevoflurane, USP, which occurs primarily in the presence of desiccated CO2 absorbents, is discussed later. In the first pathway, the defluorination pathway, the production of degradants in the anesthesia circuit results from the extraction of the acidic proton in the presence of a strong base (KOH and/or NaOH) forming an alkene (Compound A) from sevoflurane, USP similar to formation of 2-bromo-2-chloro-1,1-difluoro ethylene (BCDFE) from halothane. Laboratory simulations have shown that the concentration of these degradants is inversely correlated with the fresh gas flow rate (See Figure 1). Since the reaction of carbon dioxide with absorbents is exothermic, the temperature increase will be determined by quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anesthesia circle system, metabolic status of the patient, and ventilation. The relationship of temperature produced by varying levels of CO2 and Compound A production is illustrated in the following in vitro simulation where CO2 was added to a circle absorber system. Compound A concentration in a circle absorber system increases as a function of increasing CO2 absorbent temperature and composition (Baralyme producing higher levels than soda lime), increased body temperature, and increased minute ventilation, and decreasing fresh gas flow rates. It has been reported that the concentration of Compound A increases significantly with prolonged dehydration of Baralyme. Compound A exposure in patients also has been shown to rise with increased sevoflurane, USP concentrations and duration of anesthesia. In a clinical study in which sevoflurane, USP was administered to patients under low flow conditions for ≥ 2 hours at flow rates of 1 Liter/minute, Compound A levels were measured in an effort to determine the relationship between MAC hours and Compound A levels produced. The relationship between Compound A levels and sevoflurane, USP exposure are shown in Figure 2a. Compound A has been shown to be nephrotoxic in rats after exposures that have varied in duration from one to three hours. No histopathologic change was seen at a concentration of up to 270 ppm for one hour. Sporadic single cell necrosis of proximal tubule cells has been reported at a concentration of 114 ppm after a 3-hour exposure to Compound A in rats. The LC50 reported at 1 hour is 1050-1090 ppm (male-female) and, at 3 hours, 350-490 ppm (male-female). An experiment was performed comparing sevoflurane, USP plus 75 or 100 ppm Compound A with an active control to evaluate the potential nephrotoxicity of Compound A in non-human primates. A single 8-hour exposure of Sevoflurane, USP in the presence of Compound A produced single-cell renal tubular degeneration and single-cell necrosis in cynomolgus monkeys. These changes are consistent with the increased urinary protein, glucose level and enzymic activity noted on days one and three on the clinical pathology evaluation. This nephrotoxicity produced by Compound A is dose and duration of exposure dependent. At a fresh gas flow rate of 1 L/min, mean maximum concentrations of Compound A in the anesthesia circuit in clinical settings are approximately 20 ppm (0.002%) with soda lime and 30 ppm (0.003%) with Baralyme in adult patients; mean maximum concentrations in pediatric patients with soda lime are about half those found in adults. The highest concentration observed in a single patient with Baralyme was 61 ppm (0.0061%) and 32 ppm (0.0032%) with soda lime. The levels of Compound A at which toxicity occurs in humans is not known. The second pathway for degradation of sevoflurane, USP occurs primarily in the presence of desiccated CO2 absorbents and leads to the dissociation of sevoflurane, USP into hexafluoroisopropanol (HFIP) and formaldehyde. HFIP is inactive, non-genotoxic, rapidly glucuronidated and cleared by the liver. Formaldehyde is present during normal metabolic processes. Upon exposure to a highly desiccated absorbent, formaldehyde can further degrade into methanol and formate. Formate can contribute to the formation of carbon monoxide in the presence of high temperature that can be associated with desiccated Baralyme®. Methanol can react with Compound A to form the methoxy addition product Compound B. Compound B can undergo further HF elimination to form Compounds C, D, and E. Sevoflurane, USP degradants were observed in the respiratory circuit of an experimental anesthesia machine using desiccated CO2 absorbents and maximum sevoflurane, USP concentrations (8%) for extended periods of time (˃ 2 hours). Concentrations of formaldehyde observed with desiccated soda lime in this experimental anesthesia respiratory circuit were consistent with levels that could potentially result in respiratory irritation. Although KOH containing CO2 absorbents are no longer commercially available, in the laboratory experiments, exposure of sevoflurane, USP to the desiccated KOH containing CO2 absorbent, Baralyme, resulted in the detection of substantially greater degradant levels.</Description>
</NDC>
<NDC>
<NDCCode>10135-655-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-655-01) </PackageDescription>
<NDC11Code>10135-0655-01</NDC11Code>
<ProductNDC>10135-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206505</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC],Sulfones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white to yellow crystalline powder. Sparingly soluble in alcohol; Soluble in acetone and in dilute mineral acids; practically insoluble in water. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose. USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>10135-655-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10135-655-30) </PackageDescription>
<NDC11Code>10135-0655-30</NDC11Code>
<ProductNDC>10135-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206505</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC],Sulfones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white to yellow crystalline powder. Sparingly soluble in alcohol; Soluble in acetone and in dilute mineral acids; practically insoluble in water. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose. USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>10237-655-09</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10237-655-09) / 25 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0655-09</NDC11Code>
<ProductNDC>10237-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peroxicare</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20120129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-655-12</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (10237-655-12) / 170 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0655-12</NDC11Code>
<ProductNDC>10237-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peroxicare</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20120129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-655-46</NDCCode>
<PackageDescription>4 CARTON in 1 PACKAGE (10237-655-46) / 1 TUBE in 1 CARTON / 170 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0655-46</NDC11Code>
<ProductNDC>10237-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peroxicare</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20120129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-655-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10237-655-60) / 170 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0655-60</NDC11Code>
<ProductNDC>10237-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peroxicare</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20120129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-655-72</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10237-655-72) > 204 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0655-72</NDC11Code>
<ProductNDC>10237-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peroxie Care Tartar Control</ProprietaryName>
<ProprietaryNameSuffix>Healthy Gums Baking Soda And Peroxide</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20120129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13537-655-08</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-655-08) > 3.8 g in 1 TUBE (13537-655-07)</PackageDescription>
<NDC11Code>13537-0655-08</NDC11Code>
<ProductNDC>13537-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Multi-gloss Dual With Triple Gloss Effect Spf 15</ProprietaryName>
<ProprietaryNameSuffix>(rubi) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15127-655-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (15127-655-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>15127-0655-10</NDC11Code>
<ProductNDC>15127-655</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150301</StartMarketingDate>
<EndMarketingDate>20210910</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>L&R Distributors, Inc.</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150301</StartMarketingDatePackage>
<EndMarketingDatePackage>20210910</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16571-655-06</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (16571-655-06) </PackageDescription>
<NDC11Code>16571-0655-06</NDC11Code>
<ProductNDC>16571-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zafirlukast</ProprietaryName>
<NonProprietaryName>Zafirlukast Tablets</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204928</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZAFIRLUKAST</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zafirlukast Tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.</IndicationAndUsage>
<Description>Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is:. The empirical formula is: C31H33N3O6S. Zafirlukast, an off white to light pink color powder, is practically insoluble in water. It is freely soluble in tetrahydrofuran, dimethylsulfoxide and acetone. Zafirlukast Tablets are supplied as 10 and 20 mg tablets for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>16714-655-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16714-655-01) </PackageDescription>
<NDC11Code>16714-0655-01</NDC11Code>
<ProductNDC>16714-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170126</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078627</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170126</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>21695-655-20</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21695-655-20) > 20 g in 1 TUBE</PackageDescription>
<NDC11Code>21695-0655-20</NDC11Code>
<ProductNDC>21695-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19981224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075264</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tretinoin gel and cream are indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Each gram of tretinoin gel contains tretinoin in either of two strengths, 0.025% (0.25 mg) or 0.01% (0.1 mg) in a gel vehicle of hydroxypropyl cellulose, butylated hydroxytoluene, and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Each gram of tretinoin cream contains tretinoin in either of three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025% (0.25 mg) in a hydrophilic cream vehicle of: stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid. It has a molecular weight of 300.44 and has the following structural formula.</Description>
</NDC>
</NDCList>