{
"NDC": [
{
"NDCCode": "83745-188-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLE",
"NDC11Code": "83745-0188-08",
"ProductNDC": "83745-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetrizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090474",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260416",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "83745-185-08",
"PackageDescription": "240 mL in 1 BOTTLE (83745-185-08) ",
"NDC11Code": "83745-0185-08",
"ProductNDC": "83745-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride Oral Solution",
"NonProprietaryName": "Cetirizine Hydrochloride Oral Solution",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078870",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine Hydrochloride Oral Solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride is an orally active and selective HI-receptor antagonist. The chemical name is(±) - [2- [4- [(4-chlorophenyl)phenylmethyl]-1- piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN203 2HCL The molecular weight is 461.82 and the chemical structure is shown below. Cetirizine hydrochloride, USP is a white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Cetirizine Hydrochloride Oral Solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, grape flavor, glycerin, methylparaben, propylene glycol, propylparaben, sodium acetate, sucrose and purified water."
},
{
"NDCCode": "83745-249-08",
"PackageDescription": "237 mL in 1 BOTTLE (83745-249-08) ",
"NDC11Code": "83745-0249-08",
"ProductNDC": "83745-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203762",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of lactulose solution contains 10 grams lactulose (and less than 1.6 grams galactose, less than 1.2 grams lactose, and 0.1 grams or less of fructose). Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "83745-294-08",
"PackageDescription": "236.5 mL in 1 BOTTLE (83745-294-08) ",
"NDC11Code": "83745-0294-08",
"ProductNDC": "83745-294",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminocaproic Acid",
"NonProprietaryName": "Aminocaproic Acid",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213216",
"LabelerName": "Apozeal Pharmaceuticals Inc.",
"SubstanceName": "AMINOCAPROIC ACID",
"StrengthNumber": ".25",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251110",
"SamplePackage": "N",
"IndicationAndUsage": "Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).",
"Description": "Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid is soluble in water, acid and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Aminocaproic acid oral solution, USP for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients; sucralose, sorbitol solution 70%, hydrochloric acid concentrated, natural and artificial raspberry flavor and artificial bitterness modifier."
},
{
"NDCCode": "83745-405-08",
"PackageDescription": "237 mL in 1 BOTTLE (83745-405-08) ",
"NDC11Code": "83745-0405-08",
"ProductNDC": "83745-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207786",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "83745-188-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "83745-0188-04",
"ProductNDC": "83745-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetrizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090474",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251222",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "83745-188-12",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (83745-188-12) ",
"NDC11Code": "83745-0188-12",
"ProductNDC": "83745-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetrizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090474",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260416",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "83745-188-16",
"PackageDescription": "1 BOTTLE in 1 CARTON (83745-188-16) / 473 mL in 1 BOTTLE",
"NDC11Code": "83745-0188-16",
"ProductNDC": "83745-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetrizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090474",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260416",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "83745-188-24",
"PackageDescription": "240 mL in 1 BOTTLE, PLASTIC (83745-188-24) ",
"NDC11Code": "83745-0188-24",
"ProductNDC": "83745-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetrizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090474",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260416",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "83745-188-48",
"PackageDescription": "480 mL in 1 BOTTLE, PLASTIC (83745-188-48) ",
"NDC11Code": "83745-0188-48",
"ProductNDC": "83745-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetrizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090474",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260416",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "47335-188-08",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-188-08) ",
"NDC11Code": "47335-0188-08",
"ProductNDC": "47335-188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078690",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141215",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa orally disintegrating tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson’s disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa orally disintegrating tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa orally disintegrating tablet, USP is a combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa and levodopa orally disintegrating tablet is an orally administered formulation of carbidopa and levodopa which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4.H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa USP, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa orally disintegrating tablets, USP are supplied as tablets in three strengths. Carbidopa and levodopa orally disintegrating tablets 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa orally disintegrating tablets 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa orally disintegrating tablets 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are povidone, mannitol, calcium silicate, crospovidone, talc, magnesium stearate, aspartame, tutti-frutti flavor, colloidal silicon dioxide, microcrystalline cellulose. Carbidopa and levodopa orally disintegrating tablets 10 mg/100 mg and 25 mg/250 mg also contain FD&C blue #2 (aluminum lake). Carbidopa and levodopa orally disintegrating tablets 25 mg/100 mg also contain D&C Yellow #10 Aluminum Lake and FD & C Yellow 6 Lake. Meets USP dissolution test 2."
},
{
"NDCCode": "59779-188-08",
"PackageDescription": "221 mL in 1 BOTTLE, PLASTIC (59779-188-08)",
"NDC11Code": "59779-0188-08",
"ProductNDC": "59779-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Pharmacy",
"ProprietaryNameSuffix": "Pear White Tea",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "CVS PHARMACY",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".46",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR WASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "61924-188-08",
"PackageDescription": "222 mL in 1 BOTTLE, PUMP (61924-188-08)",
"NDC11Code": "61924-0188-08",
"ProductNDC": "61924-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermasarra",
"NonProprietaryName": "Otc Topical Analgesic Drug Products",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100224",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "DERMARITE INDUSTRIES, LLC",
"SubstanceName": "MENTHOL; CAMPHOR (NATURAL)",
"StrengthNumber": ".005; .005",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2018-10-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "62756-188-08",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-188-08)",
"NDC11Code": "62756-0188-08",
"ProductNDC": "62756-188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20090814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078690",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-05-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63376-188-08",
"PackageDescription": "250 g in 1 BAG (63376-188-08)",
"NDC11Code": "63376-0188-08",
"ProductNDC": "63376-188",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Moxidectin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Suzhou Pharmaceutical Technology Co.,Ltd",
"SubstanceName": "MOXIDECTIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71919-188-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-188-08) ",
"NDC11Code": "71919-0188-08",
"ProductNDC": "71919-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chininum Salicylicum",
"NonProprietaryName": "Quinine Salicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "QUININE SALICYLATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100212",
"SamplePackage": "N"
},
{
"NDCCode": "83745-186-30",
"PackageDescription": "30 mL in 1 BOTTLE (83745-186-30) ",
"NDC11Code": "83745-0186-30",
"ProductNDC": "83745-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078909",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic agent indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone oral solution, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone USP is also available as a 1 mg/mL oral solution. The inactive ingredients for this solution are benzoic acid, sodium hydroxide, sorbitol solution, purified water and tartaric acid."
},
{
"NDCCode": "83745-249-16",
"PackageDescription": "473 mL in 1 BOTTLE (83745-249-16) ",
"NDC11Code": "83745-0249-16",
"ProductNDC": "83745-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203762",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of lactulose solution contains 10 grams lactulose (and less than 1.6 grams galactose, less than 1.2 grams lactose, and 0.1 grams or less of fructose). Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "83745-249-32",
"PackageDescription": "946 mL in 1 BOTTLE (83745-249-32) ",
"NDC11Code": "83745-0249-32",
"ProductNDC": "83745-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203762",
"LabelerName": "APOZEAL PHARMACEUTICALS INC",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of lactulose solution contains 10 grams lactulose (and less than 1.6 grams galactose, less than 1.2 grams lactose, and 0.1 grams or less of fructose). Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "0024-5150-10",
"PackageDescription": "3 KIT in 1 CARTON (0024-5150-10) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-USE (0024-5154-11) * 1 mL in 1 AMPULE (0024-5152-11) ",
"NDC11Code": "00024-5150-10",
"ProductNDC": "0024-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elitek",
"NonProprietaryName": "Rasburicase",
"DosageFormName": "KIT",
"StartMarketingDate": "20020712",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103946",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020712",
"SamplePackage": "N",
"IndicationAndUsage": "Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.",
"Description": "Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 2 mL or 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188). Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188)."
},
{
"NDCCode": "0024-5151-75",
"PackageDescription": "1 KIT in 1 CARTON (0024-5151-75) * 5 mL in 1 VIAL, SINGLE-USE (0024-5155-74) * 5 mL in 1 AMPULE (0024-5153-74) ",
"NDC11Code": "00024-5151-75",
"ProductNDC": "0024-5151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elitek",
"NonProprietaryName": "Rasburicase",
"DosageFormName": "KIT",
"StartMarketingDate": "20060601",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103946",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060601",
"SamplePackage": "N",
"IndicationAndUsage": "Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.",
"Description": "Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 2 mL or 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188). Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188)."
},
{
"NDCCode": "0069-0505-02",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0069-0505-02) / 1.2 mL in 1 CARTRIDGE (0069-0505-01) ",
"NDC11Code": "00069-0505-02",
"ProductNDC": "0069-0505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ngenla",
"NonProprietaryName": "Somatrogon-ghla",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761184",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "SOMATROGON",
"StrengthNumber": "24",
"StrengthUnit": "mg/1.2mL",
"Pharm_Classes": "11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors [MoA], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230731",
"SamplePackage": "N",
"IndicationAndUsage": "NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.",
"Description": "Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa. NGENLA (somatrogon-ghla) injection is a sterile, clear and colorless to slightly light yellow solution for subcutaneous use supplied in a 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen. Each 1.2 mL of solution contains either 24 mg or 60 mg of somatrogon-ghla, and the inactive ingredients citric acid monohydrate (0.3 mg), histidine (1.9 mg), metacresol (4 mg, as a preservative), poloxamer 188 (2 mg), sodium chloride (10 mg) and sodium citrate (2.8 mg) in water for injection. NGENLA has a pH of approximately 6.6."
},
{
"NDCCode": "0069-0520-02",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0069-0520-02) / 1.2 mL in 1 CARTRIDGE (0069-0520-01) ",
"NDC11Code": "00069-0520-02",
"ProductNDC": "0069-0520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ngenla",
"NonProprietaryName": "Somatrogon-ghla",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761184",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "SOMATROGON",
"StrengthNumber": "60",
"StrengthUnit": "mg/1.2mL",
"Pharm_Classes": "11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors [MoA], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230731",
"SamplePackage": "N",
"IndicationAndUsage": "NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.",
"Description": "Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa. NGENLA (somatrogon-ghla) injection is a sterile, clear and colorless to slightly light yellow solution for subcutaneous use supplied in a 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen. Each 1.2 mL of solution contains either 24 mg or 60 mg of somatrogon-ghla, and the inactive ingredients citric acid monohydrate (0.3 mg), histidine (1.9 mg), metacresol (4 mg, as a preservative), poloxamer 188 (2 mg), sodium chloride (10 mg) and sodium citrate (2.8 mg) in water for injection. NGENLA has a pH of approximately 6.6."
},
{
"NDCCode": "0121-0956-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (0121-0956-08) / 210 mL in 1 BOTTLE",
"NDC11Code": "00121-0956-08",
"ProductNDC": "0121-0956",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atovaquone",
"NonProprietaryName": "Atovaquone",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20250404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214272",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "ATOVAQUONE",
"StrengthNumber": "750",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antimalarial [EPC], Antiprotozoal [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250404",
"SamplePackage": "N",
"IndicationAndUsage": "Atovaquone oral suspension is a quinone antimicrobial drug indicated for: 1 Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1) , 2 Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2) .",
"Description": "Atovaquone oral suspension USP is a quinone antimicrobial drug. The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula:. Atovaquone oral suspension USP is a formulation of micro-fine particles of atovaquone, USP. Each 5 mL of atovaquone oral suspension USP contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, tutti frutti flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum."
},
{
"NDCCode": "0254-1010-19",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0254-1010-19) / 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00254-1010-19",
"ProductNDC": "0254-1010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazoxide",
"NonProprietaryName": "Diazoxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20200721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210799",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DIAZOXIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200721",
"SamplePackage": "N",
"IndicationAndUsage": "Diazoxide oral suspension is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: 1 Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy., 2 Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. Diazoxide oral suspension may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.",
"Description": "Diazoxide Oral Suspension, USP is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. Diazoxide oral suspension contains 50 mg of diazoxide, USP in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.29%. Other ingredients include sorbitol solution, chocolate mint type flavor, propylene glycol, magnesium aluminum silicate, carboxymethylcellulose sodium, sodium benzoate, methylparaben, poloxamer 188, propylparaben, FD&C Red No. 40, FD&C Yellow No. 6 and purified water. Hydrochloric acid may be added to adjust pH. Diazoxide has the following structural formula. Diazoxide is 7-chloro-3-methyl-2H-1,2,4-benzothiadiazine 1,1-dioxide with the empirical formula C8H7ClN2O2S and the molecular weight 230.7. It is a white powder practically insoluble to sparingly soluble in water."
},
{
"NDCCode": "0480-3273-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56) ",
"NDC11Code": "00480-3273-56",
"ProductNDC": "0480-3273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvaiz",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216774",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG CHOLINE",
"StrengthNumber": "9",
"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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ 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 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating."
},
{
"NDCCode": "0480-3274-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3274-56) ",
"NDC11Code": "00480-3274-56",
"ProductNDC": "0480-3274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvaiz",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216774",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG CHOLINE",
"StrengthNumber": "18",
"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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ 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 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating."
},
{
"NDCCode": "0480-3275-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3275-56) ",
"NDC11Code": "00480-3275-56",
"ProductNDC": "0480-3275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvaiz",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216774",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG CHOLINE",
"StrengthNumber": "36",
"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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ 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 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating."
},
{
"NDCCode": "0480-3276-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3276-56) ",
"NDC11Code": "00480-3276-56",
"ProductNDC": "0480-3276",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvaiz",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216774",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG CHOLINE",
"StrengthNumber": "54",
"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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ 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 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating."
},
{
"NDCCode": "0615-8504-05",
"PackageDescription": "15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8504-05) ",
"NDC11Code": "00615-8504-05",
"ProductNDC": "0615-8504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211020",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240716",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: : 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink, round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14."
}
]
}
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<NDCList>
<NDC>
<NDCCode>83745-188-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>83745-0188-08</NDC11Code>
<ProductNDC>83745-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetrizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090474</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83745-185-08</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE (83745-185-08) </PackageDescription>
<NDC11Code>83745-0185-08</NDC11Code>
<ProductNDC>83745-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride Oral Solution</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride Oral Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078870</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine Hydrochloride Oral Solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride is an orally active and selective HI-receptor antagonist. The chemical name is(±) - [2- [4- [(4-chlorophenyl)phenylmethyl]-1- piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN203 2HCL The molecular weight is 461.82 and the chemical structure is shown below. Cetirizine hydrochloride, USP is a white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Cetirizine Hydrochloride Oral Solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, grape flavor, glycerin, methylparaben, propylene glycol, propylparaben, sodium acetate, sucrose and purified water.</Description>
</NDC>
<NDC>
<NDCCode>83745-249-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (83745-249-08) </PackageDescription>
<NDC11Code>83745-0249-08</NDC11Code>
<ProductNDC>83745-249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203762</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of lactulose solution contains 10 grams lactulose (and less than 1.6 grams galactose, less than 1.2 grams lactose, and 0.1 grams or less of fructose). Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>83745-294-08</NDCCode>
<PackageDescription>236.5 mL in 1 BOTTLE (83745-294-08) </PackageDescription>
<NDC11Code>83745-0294-08</NDC11Code>
<ProductNDC>83745-294</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminocaproic Acid</ProprietaryName>
<NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213216</ApplicationNumber>
<LabelerName>Apozeal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMINOCAPROIC ACID</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).</IndicationAndUsage>
<Description>Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid is soluble in water, acid and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Aminocaproic acid oral solution, USP for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients; sucralose, sorbitol solution 70%, hydrochloric acid concentrated, natural and artificial raspberry flavor and artificial bitterness modifier.</Description>
</NDC>
<NDC>
<NDCCode>83745-405-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (83745-405-08) </PackageDescription>
<NDC11Code>83745-0405-08</NDC11Code>
<ProductNDC>83745-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207786</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>83745-188-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>83745-0188-04</NDC11Code>
<ProductNDC>83745-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetrizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090474</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83745-188-12</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (83745-188-12) </PackageDescription>
<NDC11Code>83745-0188-12</NDC11Code>
<ProductNDC>83745-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetrizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090474</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83745-188-16</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (83745-188-16) / 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>83745-0188-16</NDC11Code>
<ProductNDC>83745-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetrizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090474</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83745-188-24</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE, PLASTIC (83745-188-24) </PackageDescription>
<NDC11Code>83745-0188-24</NDC11Code>
<ProductNDC>83745-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetrizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090474</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83745-188-48</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE, PLASTIC (83745-188-48) </PackageDescription>
<NDC11Code>83745-0188-48</NDC11Code>
<ProductNDC>83745-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetrizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090474</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47335-188-08</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-188-08) </PackageDescription>
<NDC11Code>47335-0188-08</NDC11Code>
<ProductNDC>47335-188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078690</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa orally disintegrating tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson’s disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa orally disintegrating tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa orally disintegrating tablet, USP is a combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa and levodopa orally disintegrating tablet is an orally administered formulation of carbidopa and levodopa which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4.H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa USP, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa orally disintegrating tablets, USP are supplied as tablets in three strengths. Carbidopa and levodopa orally disintegrating tablets 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa orally disintegrating tablets 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa orally disintegrating tablets 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are povidone, mannitol, calcium silicate, crospovidone, talc, magnesium stearate, aspartame, tutti-frutti flavor, colloidal silicon dioxide, microcrystalline cellulose. Carbidopa and levodopa orally disintegrating tablets 10 mg/100 mg and 25 mg/250 mg also contain FD&C blue #2 (aluminum lake). Carbidopa and levodopa orally disintegrating tablets 25 mg/100 mg also contain D&C Yellow #10 Aluminum Lake and FD & C Yellow 6 Lake. Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>59779-188-08</NDCCode>
<PackageDescription>221 mL in 1 BOTTLE, PLASTIC (59779-188-08)</PackageDescription>
<NDC11Code>59779-0188-08</NDC11Code>
<ProductNDC>59779-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Pharmacy</ProprietaryName>
<ProprietaryNameSuffix>Pear White Tea</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>CVS PHARMACY</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.46</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR WASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61924-188-08</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE, PUMP (61924-188-08)</PackageDescription>
<NDC11Code>61924-0188-08</NDC11Code>
<ProductNDC>61924-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermasarra</ProprietaryName>
<NonProprietaryName>Otc Topical Analgesic Drug Products</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100224</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>DERMARITE INDUSTRIES, LLC</LabelerName>
<SubstanceName>MENTHOL; CAMPHOR (NATURAL)</SubstanceName>
<StrengthNumber>.005; .005</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62756-188-08</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-188-08)</PackageDescription>
<NDC11Code>62756-0188-08</NDC11Code>
<ProductNDC>62756-188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078690</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-30</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63376-188-08</NDCCode>
<PackageDescription>250 g in 1 BAG (63376-188-08)</PackageDescription>
<NDC11Code>63376-0188-08</NDC11Code>
<ProductNDC>63376-188</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Moxidectin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Suzhou Pharmaceutical Technology Co.,Ltd</LabelerName>
<SubstanceName>MOXIDECTIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71919-188-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-188-08) </PackageDescription>
<NDC11Code>71919-0188-08</NDC11Code>
<ProductNDC>71919-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chininum Salicylicum</ProprietaryName>
<NonProprietaryName>Quinine Salicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100212</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>QUININE SALICYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83745-186-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (83745-186-30) </PackageDescription>
<NDC11Code>83745-0186-30</NDC11Code>
<ProductNDC>83745-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078909</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is an atypical antipsychotic agent indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone oral solution, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone USP is also available as a 1 mg/mL oral solution. The inactive ingredients for this solution are benzoic acid, sodium hydroxide, sorbitol solution, purified water and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>83745-249-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (83745-249-16) </PackageDescription>
<NDC11Code>83745-0249-16</NDC11Code>
<ProductNDC>83745-249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203762</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of lactulose solution contains 10 grams lactulose (and less than 1.6 grams galactose, less than 1.2 grams lactose, and 0.1 grams or less of fructose). Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>83745-249-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE (83745-249-32) </PackageDescription>
<NDC11Code>83745-0249-32</NDC11Code>
<ProductNDC>83745-249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203762</ApplicationNumber>
<LabelerName>APOZEAL PHARMACEUTICALS INC</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of lactulose solution contains 10 grams lactulose (and less than 1.6 grams galactose, less than 1.2 grams lactose, and 0.1 grams or less of fructose). Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>0024-5150-10</NDCCode>
<PackageDescription>3 KIT in 1 CARTON (0024-5150-10) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-USE (0024-5154-11) * 1 mL in 1 AMPULE (0024-5152-11) </PackageDescription>
<NDC11Code>00024-5150-10</NDC11Code>
<ProductNDC>0024-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elitek</ProprietaryName>
<NonProprietaryName>Rasburicase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20020712</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103946</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.</IndicationAndUsage>
<Description>Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 2 mL or 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188). Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188).</Description>
</NDC>
<NDC>
<NDCCode>0024-5151-75</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0024-5151-75) * 5 mL in 1 VIAL, SINGLE-USE (0024-5155-74) * 5 mL in 1 AMPULE (0024-5153-74) </PackageDescription>
<NDC11Code>00024-5151-75</NDC11Code>
<ProductNDC>0024-5151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elitek</ProprietaryName>
<NonProprietaryName>Rasburicase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060601</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103946</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.</IndicationAndUsage>
<Description>Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 2 mL or 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188). Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188).</Description>
</NDC>
<NDC>
<NDCCode>0069-0505-02</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0069-0505-02) / 1.2 mL in 1 CARTRIDGE (0069-0505-01) </PackageDescription>
<NDC11Code>00069-0505-02</NDC11Code>
<ProductNDC>0069-0505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ngenla</ProprietaryName>
<NonProprietaryName>Somatrogon-ghla</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230731</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761184</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>SOMATROGON</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1.2mL</StrengthUnit>
<Pharm_Classes>11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors [MoA], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.</IndicationAndUsage>
<Description>Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa. NGENLA (somatrogon-ghla) injection is a sterile, clear and colorless to slightly light yellow solution for subcutaneous use supplied in a 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen. Each 1.2 mL of solution contains either 24 mg or 60 mg of somatrogon-ghla, and the inactive ingredients citric acid monohydrate (0.3 mg), histidine (1.9 mg), metacresol (4 mg, as a preservative), poloxamer 188 (2 mg), sodium chloride (10 mg) and sodium citrate (2.8 mg) in water for injection. NGENLA has a pH of approximately 6.6.</Description>
</NDC>
<NDC>
<NDCCode>0069-0520-02</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0069-0520-02) / 1.2 mL in 1 CARTRIDGE (0069-0520-01) </PackageDescription>
<NDC11Code>00069-0520-02</NDC11Code>
<ProductNDC>0069-0520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ngenla</ProprietaryName>
<NonProprietaryName>Somatrogon-ghla</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230731</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761184</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>SOMATROGON</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1.2mL</StrengthUnit>
<Pharm_Classes>11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors [MoA], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.</IndicationAndUsage>
<Description>Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa. NGENLA (somatrogon-ghla) injection is a sterile, clear and colorless to slightly light yellow solution for subcutaneous use supplied in a 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen. Each 1.2 mL of solution contains either 24 mg or 60 mg of somatrogon-ghla, and the inactive ingredients citric acid monohydrate (0.3 mg), histidine (1.9 mg), metacresol (4 mg, as a preservative), poloxamer 188 (2 mg), sodium chloride (10 mg) and sodium citrate (2.8 mg) in water for injection. NGENLA has a pH of approximately 6.6.</Description>
</NDC>
<NDC>
<NDCCode>0121-0956-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0121-0956-08) / 210 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00121-0956-08</NDC11Code>
<ProductNDC>0121-0956</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atovaquone</ProprietaryName>
<NonProprietaryName>Atovaquone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214272</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>ATOVAQUONE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atovaquone oral suspension is a quinone antimicrobial drug indicated for: 1 Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1) , 2 Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2) .</IndicationAndUsage>
<Description>Atovaquone oral suspension USP is a quinone antimicrobial drug. The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula:. Atovaquone oral suspension USP is a formulation of micro-fine particles of atovaquone, USP. Each 5 mL of atovaquone oral suspension USP contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, tutti frutti flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0254-1010-19</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0254-1010-19) / 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00254-1010-19</NDC11Code>
<ProductNDC>0254-1010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazoxide</ProprietaryName>
<NonProprietaryName>Diazoxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210799</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DIAZOXIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazoxide oral suspension is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: 1 Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy., 2 Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. Diazoxide oral suspension may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.</IndicationAndUsage>
<Description>Diazoxide Oral Suspension, USP is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. Diazoxide oral suspension contains 50 mg of diazoxide, USP in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.29%. Other ingredients include sorbitol solution, chocolate mint type flavor, propylene glycol, magnesium aluminum silicate, carboxymethylcellulose sodium, sodium benzoate, methylparaben, poloxamer 188, propylparaben, FD&C Red No. 40, FD&C Yellow No. 6 and purified water. Hydrochloric acid may be added to adjust pH. Diazoxide has the following structural formula. Diazoxide is 7-chloro-3-methyl-2H-1,2,4-benzothiadiazine 1,1-dioxide with the empirical formula C8H7ClN2O2S and the molecular weight 230.7. It is a white powder practically insoluble to sparingly soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>0480-3273-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56) </PackageDescription>
<NDC11Code>00480-3273-56</NDC11Code>
<ProductNDC>0480-3273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvaiz</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216774</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG CHOLINE</SubstanceName>
<StrengthNumber>9</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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ 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 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating.</Description>
</NDC>
<NDC>
<NDCCode>0480-3274-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3274-56) </PackageDescription>
<NDC11Code>00480-3274-56</NDC11Code>
<ProductNDC>0480-3274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvaiz</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216774</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG CHOLINE</SubstanceName>
<StrengthNumber>18</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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ 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 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating.</Description>
</NDC>
<NDC>
<NDCCode>0480-3275-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3275-56) </PackageDescription>
<NDC11Code>00480-3275-56</NDC11Code>
<ProductNDC>0480-3275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvaiz</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216774</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG CHOLINE</SubstanceName>
<StrengthNumber>36</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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ 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 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating.</Description>
</NDC>
<NDC>
<NDCCode>0480-3276-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3276-56) </PackageDescription>
<NDC11Code>00480-3276-56</NDC11Code>
<ProductNDC>0480-3276</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvaiz</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216774</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG CHOLINE</SubstanceName>
<StrengthNumber>54</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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ 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 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating.</Description>
</NDC>
<NDC>
<NDCCode>0615-8504-05</NDCCode>
<PackageDescription>15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8504-05) </PackageDescription>
<NDC11Code>00615-8504-05</NDC11Code>
<ProductNDC>0615-8504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211020</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: : 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink, round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
</NDC>
</NDCList>