{
"NDC": [
{
"NDCCode": "42291-564-12",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-564-12) ",
"NDC11Code": "42291-0564-12",
"ProductNDC": "42291-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203817",
"LabelerName": "AvKARE",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "1.2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190918",
"SamplePackage": "N"
},
{
"NDCCode": "11410-564-12",
"PackageDescription": "30 mL in 1 BOTTLE, PUMP (11410-564-12)",
"NDC11Code": "11410-0564-12",
"ProductNDC": "11410-564",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meaningful Beauty Cindy Crawford Maintenance 1",
"ProprietaryNameSuffix": "Daily Moisture Spf 8",
"NonProprietaryName": "Octinoxate And Avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE",
"StrengthNumber": "5; 3",
"StrengthUnit": "mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "11410-564-72",
"PackageDescription": "1 BOTTLE, PUMP in 1 BOX (11410-564-72) > 30 mL in 1 BOTTLE, PUMP (11410-564-12)",
"NDC11Code": "11410-0564-72",
"ProductNDC": "11410-564",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meaningful Beauty Cindy Crawford Maintenance 1",
"ProprietaryNameSuffix": "Daily Moisture Spf 8",
"NonProprietaryName": "Octinoxate And Avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE",
"StrengthNumber": "5; 3",
"StrengthUnit": "mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68428-564-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-564-12) ",
"NDC11Code": "68428-0564-12",
"ProductNDC": "68428-564",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Picricum Acidum",
"NonProprietaryName": "Picric Acid",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PICRIC ACID",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "42291-024-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (42291-024-12) ",
"NDC11Code": "42291-0024-12",
"ProductNDC": "42291-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208327",
"LabelerName": "AvKARE",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. USP dissolution test pending."
},
{
"NDCCode": "42291-032-12",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (42291-032-12) ",
"NDC11Code": "42291-0032-12",
"ProductNDC": "42291-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Icosapent",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209499",
"LabelerName": "AvKARE",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240124",
"SamplePackage": "N",
"IndicationAndUsage": "Icosapent ethyl capsules are indicated: 1 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.",
"Description": "Icosapent ethyl capsules, a lipid-regulating agent, is supplied as a 1 gram transparent natural colored oblong shaped, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C 22H 34O 2and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure:. Icosapent ethyl capsules also contain the following inactive ingredients: alpha tocopherol, gelatin, glycerin, mannitol, sorbitol, and purified water. The imprinting Opacode NSP-78-18022 White contains, ammonium hydroxide, macrogol, polyvinyl acetate phthalate, propylene glycol and titanium dioxide."
},
{
"NDCCode": "42291-046-12",
"PackageDescription": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12) ",
"NDC11Code": "42291-0046-12",
"ProductNDC": "42291-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Icosapent Ethyl",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209525",
"LabelerName": "AvKARE",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Icosapent ethyl capsules are indicated: 1 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.",
"Description": "Icosapent ethyl, a lipid-regulating agent, is supplied as either a 500 milligram or a 1 gram, transparent, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains either 500 milligrams of icosapent ethyl (in a 500 milligram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The molecular formula of icosapent ethyl is C 22H 34O 2and the molecular weight is 330.5. The chemical name for icosapent ethyl is all-cis-5,8,11,14,17-eicosapentaenoic acid ethyl ester with the following chemical structure:. Icosapent ethyl capsules also contain the following inactive ingredients: dl-alpha-tocopherol, ethyl acetate, gelatin, glycerin anhydrous, iron oxide black, polyethylene glycol 400, polyvinyl acetate phthalate, propylene glycol, and purified water."
},
{
"NDCCode": "42291-055-12",
"PackageDescription": "1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP",
"NDC11Code": "42291-0055-12",
"ProductNDC": "42291-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212506",
"LabelerName": "AvKARE",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230829",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).",
"Description": "Diclofenac sodium topical solution USP, 2% w/w, contains diclofenac sodium, USP a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug, and is available as a clear, colorless to faintly pink or orange solution for topical application. The chemical name is 2 [(2,6-dichlorophenyl) amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2,and it has the following chemical structure. Each 1 gram of solution contains 20 mg of diclofenac sodium, USP. The inactive ingredients: dimethyl sulfoxide USP (DMSO, 45.5% w/w), ethanol (31.3% v/v), purified water, propylene glycol, and hydroxypropyl cellulose."
},
{
"NDCCode": "42291-154-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (42291-154-12) ",
"NDC11Code": "42291-0154-12",
"ProductNDC": "42291-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077563",
"LabelerName": "AvKARE",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200403",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride tablets USP, for oral administration, are available in the following strengths: 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&C yellow # 6, and both the 5 mg and 10 mg tablets contain iron oxide yellow."
},
{
"NDCCode": "42291-167-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (42291-167-12) ",
"NDC11Code": "42291-0167-12",
"ProductNDC": "42291-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204741",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170414",
"SamplePackage": "N"
},
{
"NDCCode": "42291-191-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (42291-191-12) ",
"NDC11Code": "42291-0191-12",
"ProductNDC": "42291-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091649",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150320",
"SamplePackage": "N"
},
{
"NDCCode": "42291-473-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (42291-473-12) ",
"NDC11Code": "42291-0473-12",
"ProductNDC": "42291-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etravirine",
"NonProprietaryName": "Etravirine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214196",
"LabelerName": "AvKARE",
"SubstanceName": "ETRAVIRINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221004",
"SamplePackage": "N",
"IndicationAndUsage": "Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14)].",
"Description": "Etravirine, USP is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl) amino]-4-pyrimidinyl] oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C 20H 15BrN 6O and its molecular weight is 435.28 g/mol. Etravirine, USP has the following structural formula:. Etravirine, USP is a white to slightly yellowish-brown powder. Etravirine, USP is practically insoluble in water and freely soluble in some organic solvents like N,N-dimethylformamide and tetrahydrofuran. Etravirine tablets, USP are for oral administration. Each etravirine tablet, USP contains 25 mg, 100 mg or 200 mg of etravirine, USP. It also contains the inactive ingredients: croscarmellose sodium, crospovidone (type A), colloidal silicon dioxide, hypromellose, low-substituted hydroxy propyl cellulose, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "42291-497-12",
"PackageDescription": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-12) ",
"NDC11Code": "42291-0497-12",
"ProductNDC": "42291-497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220331",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078596",
"LabelerName": "AvKARE",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230425",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N"
},
{
"NDCCode": "42291-575-12",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (42291-575-12) > 120 SPRAY, METERED in 1 BOTTLE, PUMP",
"NDC11Code": "42291-0575-12",
"ProductNDC": "42291-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20170608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207989",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42291-605-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (42291-605-12)",
"NDC11Code": "42291-0605-12",
"ProductNDC": "42291-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077880",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "42291-657-12",
"PackageDescription": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-657-12) ",
"NDC11Code": "42291-0657-12",
"ProductNDC": "42291-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omega-3-acid Ethyl Esters",
"NonProprietaryName": "Omega-3-acid Ethyl Esters",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20150507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090973",
"LabelerName": "AvKARE",
"SubstanceName": "OMEGA-3-ACID ETHYL ESTERS",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150507",
"SamplePackage": "N",
"IndicationAndUsage": "Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use:. The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.",
"Description": "Omega-3-acid ethyl esters capsules, USP, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters capsules, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The molecular formula of EPA ethyl ester is C 22H 34O 2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:. The molecular formula of DHA ethyl ester is C 24H 36O 2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:. Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of soybean oil), and gelatin, glycerin, purified water, and white ink (components of the capsule shell). The capsule imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide."
},
{
"NDCCode": "42291-748-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (42291-748-12) ",
"NDC11Code": "42291-0748-12",
"ProductNDC": "42291-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077342",
"LabelerName": "AvKARE",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180529",
"SamplePackage": "N"
},
{
"NDCCode": "42291-759-12",
"PackageDescription": "20 TABLET in 1 BOTTLE (42291-759-12) ",
"NDC11Code": "42291-0759-12",
"ProductNDC": "42291-759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "AvKARE",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20161031",
"SamplePackage": "N"
},
{
"NDCCode": "42291-825-12",
"PackageDescription": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-12) ",
"NDC11Code": "42291-0825-12",
"ProductNDC": "42291-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207427",
"LabelerName": "AvKARE",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240611",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24."
},
{
"NDCCode": "42291-939-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (42291-939-12) ",
"NDC11Code": "42291-0939-12",
"ProductNDC": "42291-939",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pazopanib",
"NonProprietaryName": "Pazopanib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217517",
"LabelerName": "AvKARE",
"SubstanceName": "PAZOPANIB HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240423",
"SamplePackage": "N",
"IndicationAndUsage": "Pazopanib tablets are a kinase inhibitor indicated for the treatment of adults with: 1 advanced renal cell carcinoma (RCC). ( 1.1) , 2 advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2) .",
"Description": "Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide hydrochloride. It has the molecular formula C 21H 23N 7O 2SHCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure:. Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. Pazopanib tablets are for oral use. Each 200 mg tablet of pazopanib contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of pazopanib tablets are: Tablet Core:Magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating:Grey film-coat: hypromellose 2910, iron oxide black, polyethylene glycol 400, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "42291-932-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42291-932-30) ",
"NDC11Code": "42291-0932-30",
"ProductNDC": "42291-932",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag Olamine",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212884",
"LabelerName": "AvKARE",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260216",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) , 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) .",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4 2(C 2H 7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide."
},
{
"NDCCode": "42291-933-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42291-933-30) ",
"NDC11Code": "42291-0933-30",
"ProductNDC": "42291-933",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag Olamine",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212884",
"LabelerName": "AvKARE",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260216",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) , 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) .",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4 2(C 2H 7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide."
},
{
"NDCCode": "42291-934-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42291-934-30) ",
"NDC11Code": "42291-0934-30",
"ProductNDC": "42291-934",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag Olamine",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212884",
"LabelerName": "AvKARE",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260216",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) , 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) .",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4 2(C 2H 7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide."
},
{
"NDCCode": "42291-935-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42291-935-30) ",
"NDC11Code": "42291-0935-30",
"ProductNDC": "42291-935",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag Olamine",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212884",
"LabelerName": "AvKARE",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260216",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) , 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) .",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4 2(C 2H 7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide."
},
{
"NDCCode": "0054-0962-13",
"PackageDescription": "30 TABLET in 1 BOTTLE (0054-0962-13) ",
"NDC11Code": "00054-0962-13",
"ProductNDC": "0054-0962",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220033",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag tablet is a thrombopoietin receptor agonist indicated:. for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1). for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2). in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3). for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)Limitations of Use:. Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4) .",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in water, slightly soluble in methanol, and practically insoluble in 0.1 M hydrochloric acid. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, silicified microcrystalline cellulose, partially pregelatinized maize starch, povidone and sodium starch glycolate. Coating: FD&C Yellow #6 aluminum lake (25-mg tablet), FD&C blue#2 aluminum lake (50-mg tablet), black iron oxide and iron oxide red (75-mg tablet), hypromellose, polyethylene glycol, polysorbate 80 (12.5-mg tablet) and titanium dioxide."
},
{
"NDCCode": "0054-0963-13",
"PackageDescription": "30 TABLET in 1 BOTTLE (0054-0963-13) ",
"NDC11Code": "00054-0963-13",
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"IndicationAndUsage": "Eltrombopag tablet is a thrombopoietin receptor agonist indicated:. for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1). for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2). in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3). for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)Limitations of Use:. Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4) .",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in water, slightly soluble in methanol, and practically insoluble in 0.1 M hydrochloric acid. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, silicified microcrystalline cellulose, partially pregelatinized maize starch, povidone and sodium starch glycolate. Coating: FD&C Yellow #6 aluminum lake (25-mg tablet), FD&C blue#2 aluminum lake (50-mg tablet), black iron oxide and iron oxide red (75-mg tablet), hypromellose, polyethylene glycol, polysorbate 80 (12.5-mg tablet) and titanium dioxide."
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"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in water, slightly soluble in methanol, and practically insoluble in 0.1 M hydrochloric acid. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, silicified microcrystalline cellulose, partially pregelatinized maize starch, povidone and sodium starch glycolate. Coating: FD&C Yellow #6 aluminum lake (25-mg tablet), FD&C blue#2 aluminum lake (50-mg tablet), black iron oxide and iron oxide red (75-mg tablet), hypromellose, polyethylene glycol, polysorbate 80 (12.5-mg tablet) and titanium dioxide."
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"IndicationAndUsage": "Eltrombopag tablet is a thrombopoietin receptor agonist indicated:. for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1). for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2). in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3). for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)Limitations of Use:. Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4) .",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in water, slightly soluble in methanol, and practically insoluble in 0.1 M hydrochloric acid. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, silicified microcrystalline cellulose, partially pregelatinized maize starch, povidone and sodium starch glycolate. Coating: FD&C Yellow #6 aluminum lake (25-mg tablet), FD&C blue#2 aluminum lake (50-mg tablet), black iron oxide and iron oxide red (75-mg tablet), hypromellose, polyethylene glycol, polysorbate 80 (12.5-mg tablet) and titanium dioxide."
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"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
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"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>42291-032-12</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (42291-032-12) </PackageDescription>
<NDC11Code>42291-0032-12</NDC11Code>
<ProductNDC>42291-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Icosapent</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209499</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Icosapent ethyl capsules are indicated: 1 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.</IndicationAndUsage>
<Description>Icosapent ethyl capsules, a lipid-regulating agent, is supplied as a 1 gram transparent natural colored oblong shaped, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C 22H 34O 2and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure:. Icosapent ethyl capsules also contain the following inactive ingredients: alpha tocopherol, gelatin, glycerin, mannitol, sorbitol, and purified water. The imprinting Opacode NSP-78-18022 White contains, ammonium hydroxide, macrogol, polyvinyl acetate phthalate, propylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-046-12</NDCCode>
<PackageDescription>120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12) </PackageDescription>
<NDC11Code>42291-0046-12</NDC11Code>
<ProductNDC>42291-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Icosapent Ethyl</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209525</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Icosapent ethyl capsules are indicated: 1 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.</IndicationAndUsage>
<Description>Icosapent ethyl, a lipid-regulating agent, is supplied as either a 500 milligram or a 1 gram, transparent, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains either 500 milligrams of icosapent ethyl (in a 500 milligram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The molecular formula of icosapent ethyl is C 22H 34O 2and the molecular weight is 330.5. The chemical name for icosapent ethyl is all-cis-5,8,11,14,17-eicosapentaenoic acid ethyl ester with the following chemical structure:. Icosapent ethyl capsules also contain the following inactive ingredients: dl-alpha-tocopherol, ethyl acetate, gelatin, glycerin anhydrous, iron oxide black, polyethylene glycol 400, polyvinyl acetate phthalate, propylene glycol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>42291-055-12</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>42291-0055-12</NDC11Code>
<ProductNDC>42291-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212506</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).</IndicationAndUsage>
<Description>Diclofenac sodium topical solution USP, 2% w/w, contains diclofenac sodium, USP a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug, and is available as a clear, colorless to faintly pink or orange solution for topical application. The chemical name is 2 [(2,6-dichlorophenyl) amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2,and it has the following chemical structure. Each 1 gram of solution contains 20 mg of diclofenac sodium, USP. The inactive ingredients: dimethyl sulfoxide USP (DMSO, 45.5% w/w), ethanol (31.3% v/v), purified water, propylene glycol, and hydroxypropyl cellulose.</Description>
</NDC>
<NDC>
<NDCCode>42291-154-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (42291-154-12) </PackageDescription>
<NDC11Code>42291-0154-12</NDC11Code>
<ProductNDC>42291-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077563</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride tablets USP, for oral administration, are available in the following strengths: 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&C yellow # 6, and both the 5 mg and 10 mg tablets contain iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>42291-167-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (42291-167-12) </PackageDescription>
<NDC11Code>42291-0167-12</NDC11Code>
<ProductNDC>42291-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204741</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-191-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (42291-191-12) </PackageDescription>
<NDC11Code>42291-0191-12</NDC11Code>
<ProductNDC>42291-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091649</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-473-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (42291-473-12) </PackageDescription>
<NDC11Code>42291-0473-12</NDC11Code>
<ProductNDC>42291-473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etravirine</ProprietaryName>
<NonProprietaryName>Etravirine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214196</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ETRAVIRINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Etravirine, USP is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl) amino]-4-pyrimidinyl] oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C 20H 15BrN 6O and its molecular weight is 435.28 g/mol. Etravirine, USP has the following structural formula:. Etravirine, USP is a white to slightly yellowish-brown powder. Etravirine, USP is practically insoluble in water and freely soluble in some organic solvents like N,N-dimethylformamide and tetrahydrofuran. Etravirine tablets, USP are for oral administration. Each etravirine tablet, USP contains 25 mg, 100 mg or 200 mg of etravirine, USP. It also contains the inactive ingredients: croscarmellose sodium, crospovidone (type A), colloidal silicon dioxide, hypromellose, low-substituted hydroxy propyl cellulose, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>42291-497-12</NDCCode>
<PackageDescription>120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-12) </PackageDescription>
<NDC11Code>42291-0497-12</NDC11Code>
<ProductNDC>42291-497</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220331</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078596</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230425</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-575-12</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (42291-575-12) > 120 SPRAY, METERED in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>42291-0575-12</NDC11Code>
<ProductNDC>42291-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207989</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42291-605-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (42291-605-12)</PackageDescription>
<NDC11Code>42291-0605-12</NDC11Code>
<ProductNDC>42291-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077880</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-657-12</NDCCode>
<PackageDescription>120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-657-12) </PackageDescription>
<NDC11Code>42291-0657-12</NDC11Code>
<ProductNDC>42291-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omega-3-acid Ethyl Esters</ProprietaryName>
<NonProprietaryName>Omega-3-acid Ethyl Esters</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090973</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>OMEGA-3-ACID ETHYL ESTERS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use:. The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.</IndicationAndUsage>
<Description>Omega-3-acid ethyl esters capsules, USP, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters capsules, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The molecular formula of EPA ethyl ester is C 22H 34O 2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:. The molecular formula of DHA ethyl ester is C 24H 36O 2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:. Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of soybean oil), and gelatin, glycerin, purified water, and white ink (components of the capsule shell). The capsule imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-748-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (42291-748-12) </PackageDescription>
<NDC11Code>42291-0748-12</NDC11Code>
<ProductNDC>42291-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077342</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-759-12</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (42291-759-12) </PackageDescription>
<NDC11Code>42291-0759-12</NDC11Code>
<ProductNDC>42291-759</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-08</LastUpdate>
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<StartMarketingDatePackage>20161031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<PackageDescription>120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-12) </PackageDescription>
<NDC11Code>42291-0825-12</NDC11Code>
<ProductNDC>42291-825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207427</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<StartMarketingDatePackage>20240611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24.</Description>
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<NDC>
<NDCCode>42291-939-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (42291-939-12) </PackageDescription>
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<ProductNDC>42291-939</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pazopanib</ProprietaryName>
<NonProprietaryName>Pazopanib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217517</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PAZOPANIB HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pazopanib tablets are a kinase inhibitor indicated for the treatment of adults with: 1 advanced renal cell carcinoma (RCC). ( 1.1) , 2 advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2) .</IndicationAndUsage>
<Description>Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide hydrochloride. It has the molecular formula C 21H 23N 7O 2SHCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure:. Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. Pazopanib tablets are for oral use. Each 200 mg tablet of pazopanib contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of pazopanib tablets are: Tablet Core:Magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating:Grey film-coat: hypromellose 2910, iron oxide black, polyethylene glycol 400, polysorbate 80, and titanium dioxide.</Description>
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<NDC>
<NDCCode>42291-932-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42291-932-30) </PackageDescription>
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<ProductNDC>42291-932</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag Olamine</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20260216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212884</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) , 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) .</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4 2(C 2H 7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-933-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42291-933-30) </PackageDescription>
<NDC11Code>42291-0933-30</NDC11Code>
<ProductNDC>42291-933</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag Olamine</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212884</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) , 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) .</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4 2(C 2H 7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-934-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42291-934-30) </PackageDescription>
<NDC11Code>42291-0934-30</NDC11Code>
<ProductNDC>42291-934</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag Olamine</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212884</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) , 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) .</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4 2(C 2H 7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-935-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42291-935-30) </PackageDescription>
<NDC11Code>42291-0935-30</NDC11Code>
<ProductNDC>42291-935</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag Olamine</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212884</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2) , 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3) .</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25H 22N 4O 4 2(C 2H 7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0054-0962-13</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0054-0962-13) </PackageDescription>
<NDC11Code>00054-0962-13</NDC11Code>
<ProductNDC>0054-0962</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220033</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260424</StartMarketingDatePackage>
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<IndicationAndUsage>Eltrombopag tablet is a thrombopoietin receptor agonist indicated:. for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1). for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2). in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3). for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)Limitations of Use:. Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4) .</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in water, slightly soluble in methanol, and practically insoluble in 0.1 M hydrochloric acid. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, silicified microcrystalline cellulose, partially pregelatinized maize starch, povidone and sodium starch glycolate. Coating: FD&C Yellow #6 aluminum lake (25-mg tablet), FD&C blue#2 aluminum lake (50-mg tablet), black iron oxide and iron oxide red (75-mg tablet), hypromellose, polyethylene glycol, polysorbate 80 (12.5-mg tablet) and titanium dioxide.</Description>
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<IndicationAndUsage>Eltrombopag tablet is a thrombopoietin receptor agonist indicated:. for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1). for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2). in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3). for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)Limitations of Use:. Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4) .</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in water, slightly soluble in methanol, and practically insoluble in 0.1 M hydrochloric acid. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, silicified microcrystalline cellulose, partially pregelatinized maize starch, povidone and sodium starch glycolate. Coating: FD&C Yellow #6 aluminum lake (25-mg tablet), FD&C blue#2 aluminum lake (50-mg tablet), black iron oxide and iron oxide red (75-mg tablet), hypromellose, polyethylene glycol, polysorbate 80 (12.5-mg tablet) and titanium dioxide.</Description>
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<IndicationAndUsage>Eltrombopag tablet is a thrombopoietin receptor agonist indicated:. for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1). for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2). in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3). for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)Limitations of Use:. Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4) .</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in water, slightly soluble in methanol, and practically insoluble in 0.1 M hydrochloric acid. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, silicified microcrystalline cellulose, partially pregelatinized maize starch, povidone and sodium starch glycolate. Coating: FD&C Yellow #6 aluminum lake (25-mg tablet), FD&C blue#2 aluminum lake (50-mg tablet), black iron oxide and iron oxide red (75-mg tablet), hypromellose, polyethylene glycol, polysorbate 80 (12.5-mg tablet) and titanium dioxide.</Description>
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<IndicationAndUsage>Eltrombopag tablet is a thrombopoietin receptor agonist indicated:. for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1). for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. (1.2). in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3). for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)Limitations of Use:. Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4) .</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in water, slightly soluble in methanol, and practically insoluble in 0.1 M hydrochloric acid. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core: colloidal silicon dioxide, magnesium stearate, mannitol, silicified microcrystalline cellulose, partially pregelatinized maize starch, povidone and sodium starch glycolate. Coating: FD&C Yellow #6 aluminum lake (25-mg tablet), FD&C blue#2 aluminum lake (50-mg tablet), black iron oxide and iron oxide red (75-mg tablet), hypromellose, polyethylene glycol, polysorbate 80 (12.5-mg tablet) and titanium dioxide.</Description>
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<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
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<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
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