{
"NDC": [
{
"NDCCode": "81033-123-44",
"PackageDescription": "40 CUP, UNIT-DOSE in 1 CARTON (81033-123-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-123-05) ",
"NDC11Code": "81033-0123-44",
"ProductNDC": "81033-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091286",
"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin oral solution is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin oral solution is Gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of Gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of Gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Oral Solution contains 250 mg of Gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients are glycerin, hydrochloric acid, methylparaben, propylparaben, acesulfame potassium, saccharin sodium, banana flavor and purified water."
},
{
"NDCCode": "81033-123-16",
"PackageDescription": "473 mL in 1 BOTTLE (81033-123-16) ",
"NDC11Code": "81033-0123-16",
"ProductNDC": "81033-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091286",
"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin oral solution is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin oral solution is Gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of Gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of Gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Oral Solution contains 250 mg of Gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients are glycerin, hydrochloric acid, methylparaben, propylparaben, acesulfame potassium, saccharin sodium, banana flavor and purified water."
},
{
"NDCCode": "16729-123-44",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (16729-123-44) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "16729-0123-44",
"ProductNDC": "16729-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201335",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "24909-123-44",
"PackageDescription": "44 g in 1 JAR (24909-123-44)",
"NDC11Code": "24909-0123-44",
"ProductNDC": "24909-123",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Itch, Rash And Pain Relief",
"NonProprietaryName": "Allantoin, Lidocaine",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120907",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "ALLANTOIN; LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": ".5; .5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "70281-123-44",
"PackageDescription": "475 g in 1 BOTTLE (70281-123-44)",
"NDC11Code": "70281-0123-44",
"ProductNDC": "70281-123",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No-ad Sport 50 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SolSkyn Personal Care LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2; 10; 5; 2; 5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "81033-031-44",
"PackageDescription": "40 CUP, UNIT-DOSE in 1 CARTON (81033-031-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-031-05) ",
"NDC11Code": "81033-0031-44",
"ProductNDC": "81033-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219289",
"LabelerName": "Kesin Pharma",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidineand barbiturates,so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP is designated chemically as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows:. C 21H 27ClN 2O 22HCl M.W. 447.83 g/mol. Inactive ingredientsfor hydroxyzine hydrochloride oral solution, USP are: flavadew coolmint flavour; sodium benzoate; sucrose; and purified water. Anhydrous citric acid is used for pH adjustment. The pH range is between 2.0 and 4.3."
},
{
"NDCCode": "81033-124-44",
"PackageDescription": "40 CUP, UNIT-DOSE in 1 CARTON (81033-124-44) / 6 mL in 1 CUP, UNIT-DOSE (81033-124-06) ",
"NDC11Code": "81033-0124-44",
"ProductNDC": "81033-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091286",
"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin oral solution is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin oral solution is Gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of Gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of Gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Oral Solution contains 250 mg of Gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients are glycerin, hydrochloric acid, methylparaben, propylparaben, acesulfame potassium, saccharin sodium, banana flavor and purified water."
},
{
"NDCCode": "81033-149-44",
"PackageDescription": "40 CUP, UNIT-DOSE in 1 CARTON (81033-149-44) / 10 mL in 1 CUP, UNIT-DOSE (81033-149-10) ",
"NDC11Code": "81033-0149-44",
"ProductNDC": "81033-149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sucralfate",
"NonProprietaryName": "Sucralfate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216474",
"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "SUCRALFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/10mL",
"Pharm_Classes": "Aluminum Complex [EPC], Organometallic Compounds [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240701",
"SamplePackage": "N",
"IndicationAndUsage": "Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.",
"Description": "Sucralfate Oral Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate Oral Suspension also contains: colloidal silicon dioxide, cherry flavor (containing artificial flavors, benzyl alcohol, lactic acid and maltodextrin), FD&C Red #40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion and sorbitol solution. Therapeutic category: antiulcer."
},
{
"NDCCode": "81033-150-44",
"PackageDescription": "40 CUP, UNIT-DOSE in 1 CARTON (81033-150-44) / 10 mL in 1 CUP, UNIT-DOSE (81033-150-10) ",
"NDC11Code": "81033-0150-44",
"ProductNDC": "81033-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20250807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075671",
"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250807",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).",
"Description": "Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52. The chemical formula is C 24H 32O 4and the structural formula is represented as follows:. Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, glycerin, natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. Megestrol acetate oral suspension, 40 mg/mL complies with USP Dissolution Test 2."
},
{
"NDCCode": "81033-066-20",
"PackageDescription": "200 mL in 1 BOTTLE (81033-066-20) ",
"NDC11Code": "81033-0066-20",
"ProductNDC": "81033-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Likmez",
"NonProprietaryName": "Metronidazole Oral",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216755",
"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"Description": "LIKMEZ (metronidazole) oral suspension is a nitroimidazole antimicrobial. The chemical name of metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The structural formula is shown as. Metronidazole is a white to pale yellow crystalline powder with a molecular formula of C 6H 9N 3O 3and a molecular weight of 171.2 g/mole. The pKa of metronidazole is 14.44 ± 0.10. The pH of a 1% aqueous solution of metronidazole is 5.5-7.5. It is slightly soluble in water, acetone, alcohol, and methylene chloride. LIKMEZ is an oral suspension containing 500 mg of metronidazole per 5 mL, and the following inactive ingredients: Glycerin, magnesium aluminum silicate, methylparaben, microcrystalline cellulose, natural peppermint flavor, natural strawberry flavor, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucralose, and sucrose."
},
{
"NDCCode": "50419-390-01",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (50419-390-01) ",
"NDC11Code": "50419-0390-01",
"ProductNDC": "50419-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrakvi",
"NonProprietaryName": "Larotrectinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190726",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210861",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "LAROTRECTINIB",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190726",
"SamplePackage": "N",
"IndicationAndUsage": "VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and , 3 have no satisfactory alternative treatments or that have progressed following treatment.",
"Description": "Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate. The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate."
},
{
"NDCCode": "50419-391-01",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (50419-391-01) ",
"NDC11Code": "50419-0391-01",
"ProductNDC": "50419-391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrakvi",
"NonProprietaryName": "Larotrectinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190726",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210861",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "LAROTRECTINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190726",
"SamplePackage": "N",
"IndicationAndUsage": "VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and , 3 have no satisfactory alternative treatments or that have progressed following treatment.",
"Description": "Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate. The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate."
},
{
"NDCCode": "50419-392-01",
"PackageDescription": "100 mL in 1 BOTTLE (50419-392-01) ",
"NDC11Code": "50419-0392-01",
"ProductNDC": "50419-392",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrakvi",
"NonProprietaryName": "Larotrectinib",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "OROPHARYNGEAL",
"StartMarketingDate": "20190726",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211710",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "LAROTRECTINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190726",
"SamplePackage": "N",
"IndicationAndUsage": "VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and , 3 have no satisfactory alternative treatments or that have progressed following treatment.",
"Description": "Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate. The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate."
},
{
"NDCCode": "50419-393-03",
"PackageDescription": "2 BOTTLE in 1 CARTON (50419-393-03) / 50 mL in 1 BOTTLE (50419-393-02) ",
"NDC11Code": "50419-0393-03",
"ProductNDC": "50419-393",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrakvi",
"NonProprietaryName": "Larotrectinib",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "OROPHARYNGEAL",
"StartMarketingDate": "20221206",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211710",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "LAROTRECTINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221206",
"SamplePackage": "N",
"IndicationAndUsage": "VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and , 3 have no satisfactory alternative treatments or that have progressed following treatment.",
"Description": "Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate. The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate."
},
{
"NDCCode": "69448-015-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (69448-015-05) / 7.4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "69448-0015-05",
"ProductNDC": "69448-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hercessi",
"NonProprietaryName": "Trastuzumab-strf",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761346",
"LabelerName": "Accord BioPharma Inc.",
"SubstanceName": "TRASTUZUMAB-STRF",
"StrengthNumber": "150",
"StrengthUnit": "mg/7.4mL",
"Pharm_Classes": "HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Hercessi TMis a HER2/neu receptor antagonist indicated in adults for: : 1 The treatment of HER2-overexpressing breast cancer. (1.1,1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-strf is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-strf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic puromycin. Puromycin is not detectable in the final product. HERCESSI TM(trastuzumab-strf) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of HERCESSI TMdelivers 420 mg trastuzumab-strf, histidine (6.1 mg), L-histidine hydrochloride monohydrate (9.5 mg), polysorbate 20 (1.7 mg), and trehalose (345.44 mg). Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 20 mL (420 mg trastuzumab-strf), at a pH of approximately 6. If HERCESSI TMis reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of HERCESSI TMdelivers 150 mg trastuzumab-strf, histidine (2.16 mg), L-histidine hydrochloride monohydrate (3.36 mg), polysorbate 20 (0.6 mg), and trehalose (123.229 mg). Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 7.15 mL (150 mg trastuzumab-strf), at a pH of approximately 6."
},
{
"NDCCode": "69448-016-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69448-016-11) / 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69448-0016-11",
"ProductNDC": "69448-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hercessi",
"NonProprietaryName": "Trastuzumab-strf",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761346",
"LabelerName": "Accord BioPharma Inc.",
"SubstanceName": "TRASTUZUMAB-STRF",
"StrengthNumber": "420",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Hercessi TMis a HER2/neu receptor antagonist indicated in adults for: : 1 The treatment of HER2-overexpressing breast cancer. (1.1,1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-strf is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-strf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic puromycin. Puromycin is not detectable in the final product. HERCESSI TM(trastuzumab-strf) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of HERCESSI TMdelivers 420 mg trastuzumab-strf, histidine (6.1 mg), L-histidine hydrochloride monohydrate (9.5 mg), polysorbate 20 (1.7 mg), and trehalose (345.44 mg). Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 20 mL (420 mg trastuzumab-strf), at a pH of approximately 6. If HERCESSI TMis reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of HERCESSI TMdelivers 150 mg trastuzumab-strf, histidine (2.16 mg), L-histidine hydrochloride monohydrate (3.36 mg), polysorbate 20 (0.6 mg), and trehalose (123.229 mg). Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 7.15 mL (150 mg trastuzumab-strf), at a pH of approximately 6."
},
{
"NDCCode": "69448-035-63",
"PackageDescription": "1 KIT in 1 CARTON (69448-035-63) * 20 mL in 1 VIAL, MULTI-DOSE (69448-016-11) * 20 mL in 1 VIAL (69448-034-05) ",
"NDC11Code": "69448-0035-63",
"ProductNDC": "69448-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hercessi",
"NonProprietaryName": "Trastuzumab-strf",
"DosageFormName": "KIT",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761346",
"LabelerName": "Accord BioPharma Inc.",
"Status": "Active",
"LastUpdate": "2026-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Hercessi TMis a HER2/neu receptor antagonist indicated in adults for: : 1 The treatment of HER2-overexpressing breast cancer. (1.1,1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-strf is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-strf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic puromycin. Puromycin is not detectable in the final product. HERCESSI TM(trastuzumab-strf) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of HERCESSI TMdelivers 420 mg trastuzumab-strf, histidine (6.1 mg), L-histidine hydrochloride monohydrate (9.5 mg), polysorbate 20 (1.7 mg), and trehalose (345.44 mg). Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 20 mL (420 mg trastuzumab-strf), at a pH of approximately 6. If HERCESSI TMis reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of HERCESSI TMdelivers 150 mg trastuzumab-strf, histidine (2.16 mg), L-histidine hydrochloride monohydrate (3.36 mg), polysorbate 20 (0.6 mg), and trehalose (123.229 mg). Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 7.15 mL (150 mg trastuzumab-strf), at a pH of approximately 6."
},
{
"NDCCode": "70594-123-02",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (70594-123-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-123-01) ",
"NDC11Code": "70594-0123-02",
"ProductNDC": "70594-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205694",
"LabelerName": "Xellia Pharmaceuticals USA LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231029",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)- 44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4, 5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy- 6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo- 22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula."
},
{
"NDCCode": "71777-390-01",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71777-390-01) ",
"NDC11Code": "71777-0390-01",
"ProductNDC": "71777-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrakvi",
"NonProprietaryName": "Larotrectinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210861",
"LabelerName": "Loxo Oncology, Inc.",
"SubstanceName": "LAROTRECTINIB",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181126",
"SamplePackage": "N",
"IndicationAndUsage": "VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and, 3 have no satisfactory alternative treatments or that have progressed following treatment.",
"Description": "Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate."
},
{
"NDCCode": "71777-391-01",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71777-391-01) ",
"NDC11Code": "71777-0391-01",
"ProductNDC": "71777-391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrakvi",
"NonProprietaryName": "Larotrectinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210861",
"LabelerName": "Loxo Oncology, Inc.",
"SubstanceName": "LAROTRECTINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181126",
"SamplePackage": "N",
"IndicationAndUsage": "VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and, 3 have no satisfactory alternative treatments or that have progressed following treatment.",
"Description": "Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate."
},
{
"NDCCode": "71777-392-01",
"PackageDescription": "100 mL in 1 BOTTLE (71777-392-01) ",
"NDC11Code": "71777-0392-01",
"ProductNDC": "71777-392",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrakvi",
"NonProprietaryName": "Larotrectinib",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20181126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211710",
"LabelerName": "Loxo Oncology, Inc.",
"SubstanceName": "LAROTRECTINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181126",
"SamplePackage": "N",
"IndicationAndUsage": "VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and, 3 have no satisfactory alternative treatments or that have progressed following treatment.",
"Description": "Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate."
},
{
"NDCCode": "81033-001-41",
"PackageDescription": "8 BOX in 1 CASE (81033-001-41) / 40 CUP in 1 BOX (81033-001-40) / 10 mL in 1 CUP (81033-001-10) ",
"NDC11Code": "81033-0001-41",
"ProductNDC": "81033-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna",
"NonProprietaryName": "Sennosides",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
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},
{
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"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210310",
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},
{
"NDCCode": "81033-001-51",
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"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210310",
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},
{
"NDCCode": "81033-002-30",
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"ProductNDC": "81033-002",
"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210630",
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},
{
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"StrengthUnit": "mg/5mL",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210630",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache."
},
{
"NDCCode": "81033-002-40",
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"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "ACETAMINOPHEN",
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"StrengthUnit": "mg/5mL",
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"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210630",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains due to: 1 headaches, 2 backaches, 3 toothaches, 4 muscular aches, 5 minor pain of arthritis, 6 the common cold, 7 premenstrual and menstrual cramps, 8 sore throat, 9 flu."
},
{
"NDCCode": "81033-002-41",
"PackageDescription": "8 CARTON in 1 CASE (81033-002-41) / 40 CUP, UNIT-DOSE in 1 CARTON (81033-002-40) / 10.15 mL in 1 CUP, UNIT-DOSE (81033-002-10) ",
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"ProductNDC": "81033-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
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"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "ACETAMINOPHEN",
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"StrengthUnit": "mg/5mL",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache."
},
{
"NDCCode": "81033-002-50",
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"ProductNDC": "81033-002",
"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "ACETAMINOPHEN",
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"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210630",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains due to: 1 headaches, 2 backaches, 3 toothaches, 4 muscular aches, 5 minor pain of arthritis, 6 the common cold, 7 premenstrual and menstrual cramps, 8 sore throat, 9 flu."
},
{
"NDCCode": "81033-002-51",
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"ProductNDC": "81033-002",
"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
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"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>81033-123-44</NDCCode>
<PackageDescription>40 CUP, UNIT-DOSE in 1 CARTON (81033-123-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-123-05) </PackageDescription>
<NDC11Code>81033-0123-44</NDC11Code>
<ProductNDC>81033-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091286</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin oral solution is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin oral solution is Gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of Gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of Gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Oral Solution contains 250 mg of Gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients are glycerin, hydrochloric acid, methylparaben, propylparaben, acesulfame potassium, saccharin sodium, banana flavor and purified water.</Description>
</NDC>
<NDC>
<NDCCode>81033-123-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (81033-123-16) </PackageDescription>
<NDC11Code>81033-0123-16</NDC11Code>
<ProductNDC>81033-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091286</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin oral solution is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin oral solution is Gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of Gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of Gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Oral Solution contains 250 mg of Gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients are glycerin, hydrochloric acid, methylparaben, propylparaben, acesulfame potassium, saccharin sodium, banana flavor and purified water.</Description>
</NDC>
<NDC>
<NDCCode>16729-123-44</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (16729-123-44) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16729-0123-44</NDC11Code>
<ProductNDC>16729-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201335</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>24909-123-44</NDCCode>
<PackageDescription>44 g in 1 JAR (24909-123-44)</PackageDescription>
<NDC11Code>24909-0123-44</NDC11Code>
<ProductNDC>24909-123</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Itch, Rash And Pain Relief</ProprietaryName>
<NonProprietaryName>Allantoin, Lidocaine</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120907</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>ALLANTOIN; LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5; .5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70281-123-44</NDCCode>
<PackageDescription>475 g in 1 BOTTLE (70281-123-44)</PackageDescription>
<NDC11Code>70281-0123-44</NDC11Code>
<ProductNDC>70281-123</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No-ad Sport 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SolSkyn Personal Care LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>2; 10; 5; 2; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81033-031-44</NDCCode>
<PackageDescription>40 CUP, UNIT-DOSE in 1 CARTON (81033-031-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-031-05) </PackageDescription>
<NDC11Code>81033-0031-44</NDC11Code>
<ProductNDC>81033-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219289</ApplicationNumber>
<LabelerName>Kesin Pharma</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidineand barbiturates,so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP is designated chemically as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows:. C 21H 27ClN 2O 22HCl M.W. 447.83 g/mol. Inactive ingredientsfor hydroxyzine hydrochloride oral solution, USP are: flavadew coolmint flavour; sodium benzoate; sucrose; and purified water. Anhydrous citric acid is used for pH adjustment. The pH range is between 2.0 and 4.3.</Description>
</NDC>
<NDC>
<NDCCode>81033-124-44</NDCCode>
<PackageDescription>40 CUP, UNIT-DOSE in 1 CARTON (81033-124-44) / 6 mL in 1 CUP, UNIT-DOSE (81033-124-06) </PackageDescription>
<NDC11Code>81033-0124-44</NDC11Code>
<ProductNDC>81033-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091286</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin oral solution is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin oral solution is Gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of Gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of Gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Oral Solution contains 250 mg of Gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients are glycerin, hydrochloric acid, methylparaben, propylparaben, acesulfame potassium, saccharin sodium, banana flavor and purified water.</Description>
</NDC>
<NDC>
<NDCCode>81033-149-44</NDCCode>
<PackageDescription>40 CUP, UNIT-DOSE in 1 CARTON (81033-149-44) / 10 mL in 1 CUP, UNIT-DOSE (81033-149-10) </PackageDescription>
<NDC11Code>81033-0149-44</NDC11Code>
<ProductNDC>81033-149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sucralfate</ProprietaryName>
<NonProprietaryName>Sucralfate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216474</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>SUCRALFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Pharm_Classes>Aluminum Complex [EPC], Organometallic Compounds [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.</IndicationAndUsage>
<Description>Sucralfate Oral Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate Oral Suspension also contains: colloidal silicon dioxide, cherry flavor (containing artificial flavors, benzyl alcohol, lactic acid and maltodextrin), FD&C Red #40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion and sorbitol solution. Therapeutic category: antiulcer.</Description>
</NDC>
<NDC>
<NDCCode>81033-150-44</NDCCode>
<PackageDescription>40 CUP, UNIT-DOSE in 1 CARTON (81033-150-44) / 10 mL in 1 CUP, UNIT-DOSE (81033-150-10) </PackageDescription>
<NDC11Code>81033-0150-44</NDC11Code>
<ProductNDC>81033-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075671</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).</IndicationAndUsage>
<Description>Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52. The chemical formula is C 24H 32O 4and the structural formula is represented as follows:. Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, glycerin, natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. Megestrol acetate oral suspension, 40 mg/mL complies with USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>81033-066-20</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (81033-066-20) </PackageDescription>
<NDC11Code>81033-0066-20</NDC11Code>
<ProductNDC>81033-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Likmez</ProprietaryName>
<NonProprietaryName>Metronidazole Oral</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216755</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>LIKMEZ (metronidazole) oral suspension is a nitroimidazole antimicrobial. The chemical name of metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The structural formula is shown as. Metronidazole is a white to pale yellow crystalline powder with a molecular formula of C 6H 9N 3O 3and a molecular weight of 171.2 g/mole. The pKa of metronidazole is 14.44 ± 0.10. The pH of a 1% aqueous solution of metronidazole is 5.5-7.5. It is slightly soluble in water, acetone, alcohol, and methylene chloride. LIKMEZ is an oral suspension containing 500 mg of metronidazole per 5 mL, and the following inactive ingredients: Glycerin, magnesium aluminum silicate, methylparaben, microcrystalline cellulose, natural peppermint flavor, natural strawberry flavor, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucralose, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>50419-390-01</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (50419-390-01) </PackageDescription>
<NDC11Code>50419-0390-01</NDC11Code>
<ProductNDC>50419-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrakvi</ProprietaryName>
<NonProprietaryName>Larotrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190726</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210861</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LAROTRECTINIB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and , 3 have no satisfactory alternative treatments or that have progressed following treatment.</IndicationAndUsage>
<Description>Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate. The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>50419-391-01</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (50419-391-01) </PackageDescription>
<NDC11Code>50419-0391-01</NDC11Code>
<ProductNDC>50419-391</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrakvi</ProprietaryName>
<NonProprietaryName>Larotrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190726</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210861</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LAROTRECTINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and , 3 have no satisfactory alternative treatments or that have progressed following treatment.</IndicationAndUsage>
<Description>Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate. The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>50419-392-01</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (50419-392-01) </PackageDescription>
<NDC11Code>50419-0392-01</NDC11Code>
<ProductNDC>50419-392</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrakvi</ProprietaryName>
<NonProprietaryName>Larotrectinib</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>OROPHARYNGEAL</RouteName>
<StartMarketingDate>20190726</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211710</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LAROTRECTINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and , 3 have no satisfactory alternative treatments or that have progressed following treatment.</IndicationAndUsage>
<Description>Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate. The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>50419-393-03</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (50419-393-03) / 50 mL in 1 BOTTLE (50419-393-02) </PackageDescription>
<NDC11Code>50419-0393-03</NDC11Code>
<ProductNDC>50419-393</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrakvi</ProprietaryName>
<NonProprietaryName>Larotrectinib</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>OROPHARYNGEAL</RouteName>
<StartMarketingDate>20221206</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211710</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LAROTRECTINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and , 3 have no satisfactory alternative treatments or that have progressed following treatment.</IndicationAndUsage>
<Description>Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution packaged in one bottle containing 100 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate. The oral solution packaged in two bottles each containing 50 mL contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>69448-015-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (69448-015-05) / 7.4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>69448-0015-05</NDC11Code>
<ProductNDC>69448-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hercessi</ProprietaryName>
<NonProprietaryName>Trastuzumab-strf</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761346</ApplicationNumber>
<LabelerName>Accord BioPharma Inc.</LabelerName>
<SubstanceName>TRASTUZUMAB-STRF</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/7.4mL</StrengthUnit>
<Pharm_Classes>HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hercessi TMis a HER2/neu receptor antagonist indicated in adults for: : 1 The treatment of HER2-overexpressing breast cancer. (1.1,1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-strf is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-strf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic puromycin. Puromycin is not detectable in the final product. HERCESSI TM(trastuzumab-strf) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of HERCESSI TMdelivers 420 mg trastuzumab-strf, histidine (6.1 mg), L-histidine hydrochloride monohydrate (9.5 mg), polysorbate 20 (1.7 mg), and trehalose (345.44 mg). Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 20 mL (420 mg trastuzumab-strf), at a pH of approximately 6. If HERCESSI TMis reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of HERCESSI TMdelivers 150 mg trastuzumab-strf, histidine (2.16 mg), L-histidine hydrochloride monohydrate (3.36 mg), polysorbate 20 (0.6 mg), and trehalose (123.229 mg). Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 7.15 mL (150 mg trastuzumab-strf), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>69448-016-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69448-016-11) / 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>69448-0016-11</NDC11Code>
<ProductNDC>69448-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hercessi</ProprietaryName>
<NonProprietaryName>Trastuzumab-strf</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761346</ApplicationNumber>
<LabelerName>Accord BioPharma Inc.</LabelerName>
<SubstanceName>TRASTUZUMAB-STRF</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hercessi TMis a HER2/neu receptor antagonist indicated in adults for: : 1 The treatment of HER2-overexpressing breast cancer. (1.1,1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-strf is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-strf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic puromycin. Puromycin is not detectable in the final product. HERCESSI TM(trastuzumab-strf) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of HERCESSI TMdelivers 420 mg trastuzumab-strf, histidine (6.1 mg), L-histidine hydrochloride monohydrate (9.5 mg), polysorbate 20 (1.7 mg), and trehalose (345.44 mg). Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 20 mL (420 mg trastuzumab-strf), at a pH of approximately 6. If HERCESSI TMis reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of HERCESSI TMdelivers 150 mg trastuzumab-strf, histidine (2.16 mg), L-histidine hydrochloride monohydrate (3.36 mg), polysorbate 20 (0.6 mg), and trehalose (123.229 mg). Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 7.15 mL (150 mg trastuzumab-strf), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>69448-035-63</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69448-035-63) * 20 mL in 1 VIAL, MULTI-DOSE (69448-016-11) * 20 mL in 1 VIAL (69448-034-05) </PackageDescription>
<NDC11Code>69448-0035-63</NDC11Code>
<ProductNDC>69448-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hercessi</ProprietaryName>
<NonProprietaryName>Trastuzumab-strf</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761346</ApplicationNumber>
<LabelerName>Accord BioPharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hercessi TMis a HER2/neu receptor antagonist indicated in adults for: : 1 The treatment of HER2-overexpressing breast cancer. (1.1,1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-strf is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-strf is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic puromycin. Puromycin is not detectable in the final product. HERCESSI TM(trastuzumab-strf) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of HERCESSI TMdelivers 420 mg trastuzumab-strf, histidine (6.1 mg), L-histidine hydrochloride monohydrate (9.5 mg), polysorbate 20 (1.7 mg), and trehalose (345.44 mg). Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 20 mL (420 mg trastuzumab-strf), at a pH of approximately 6. If HERCESSI TMis reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of HERCESSI TMdelivers 150 mg trastuzumab-strf, histidine (2.16 mg), L-histidine hydrochloride monohydrate (3.36 mg), polysorbate 20 (0.6 mg), and trehalose (123.229 mg). Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-strf that delivers 7.15 mL (150 mg trastuzumab-strf), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>70594-123-02</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (70594-123-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-123-01) </PackageDescription>
<NDC11Code>70594-0123-02</NDC11Code>
<ProductNDC>70594-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205694</ApplicationNumber>
<LabelerName>Xellia Pharmaceuticals USA LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)- 44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4, 5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy- 6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo- 22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>71777-390-01</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71777-390-01) </PackageDescription>
<NDC11Code>71777-0390-01</NDC11Code>
<ProductNDC>71777-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrakvi</ProprietaryName>
<NonProprietaryName>Larotrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210861</ApplicationNumber>
<LabelerName>Loxo Oncology, Inc.</LabelerName>
<SubstanceName>LAROTRECTINIB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and, 3 have no satisfactory alternative treatments or that have progressed following treatment.</IndicationAndUsage>
<Description>Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate.</Description>
</NDC>
<NDC>
<NDCCode>71777-391-01</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71777-391-01) </PackageDescription>
<NDC11Code>71777-0391-01</NDC11Code>
<ProductNDC>71777-391</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrakvi</ProprietaryName>
<NonProprietaryName>Larotrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210861</ApplicationNumber>
<LabelerName>Loxo Oncology, Inc.</LabelerName>
<SubstanceName>LAROTRECTINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and, 3 have no satisfactory alternative treatments or that have progressed following treatment.</IndicationAndUsage>
<Description>Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate.</Description>
</NDC>
<NDC>
<NDCCode>71777-392-01</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (71777-392-01) </PackageDescription>
<NDC11Code>71777-0392-01</NDC11Code>
<ProductNDC>71777-392</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrakvi</ProprietaryName>
<NonProprietaryName>Larotrectinib</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211710</ApplicationNumber>
<LabelerName>Loxo Oncology, Inc.</LabelerName>
<SubstanceName>LAROTRECTINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: 1 have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,, 2 are metastatic or where surgical resection is likely to result in severe morbidity, and, 3 have no satisfactory alternative treatments or that have progressed following treatment.</IndicationAndUsage>
<Description>Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base. The chemical name is (3S)-N-{5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate. Larotrectinib sulfate has the following chemical structure. Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility). VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink. The oral solution contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate.</Description>
</NDC>
<NDC>
<NDCCode>81033-001-41</NDCCode>
<PackageDescription>8 BOX in 1 CASE (81033-001-41) / 40 CUP in 1 BOX (81033-001-40) / 10 mL in 1 CUP (81033-001-10) </PackageDescription>
<NDC11Code>81033-0001-41</NDC11Code>
<ProductNDC>81033-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna</ProprietaryName>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>8.8</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81033-001-43</NDCCode>
<PackageDescription>8 BOX in 1 CASE (81033-001-43) / 40 CUP in 1 BOX (81033-001-42) / 15 mL in 1 CUP (81033-001-15) </PackageDescription>
<NDC11Code>81033-0001-43</NDC11Code>
<ProductNDC>81033-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna</ProprietaryName>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>8.8</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81033-001-51</NDCCode>
<PackageDescription>8 BOX in 1 CASE (81033-001-51) / 50 CUP in 1 BOX (81033-001-50) / 5 mL in 1 CUP (81033-001-05) </PackageDescription>
<NDC11Code>81033-0001-51</NDC11Code>
<ProductNDC>81033-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna</ProprietaryName>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>8.8</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81033-002-30</NDCCode>
<PackageDescription>30 CUP, UNIT-DOSE in 1 CARTON (81033-002-30) / 20.3 mL in 1 CUP, UNIT-DOSE (81033-002-20) </PackageDescription>
<NDC11Code>81033-0002-30</NDC11Code>
<ProductNDC>81033-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains due to: 1 headaches, 2 backaches, 3 toothaches, 4 muscular aches, 5 minor pain of arthritis, 6 the common cold, 7 premenstrual and menstrual cramps, 8 sore throat, 9 flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81033-002-31</NDCCode>
<PackageDescription>8 CARTON in 1 CASE (81033-002-31) / 30 CUP, UNIT-DOSE in 1 CARTON (81033-002-30) / 20.3 mL in 1 CUP, UNIT-DOSE (81033-002-20) </PackageDescription>
<NDC11Code>81033-0002-31</NDC11Code>
<ProductNDC>81033-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81033-002-40</NDCCode>
<PackageDescription>40 CUP, UNIT-DOSE in 1 CARTON (81033-002-40) / 10.15 mL in 1 CUP, UNIT-DOSE (81033-002-10) </PackageDescription>
<NDC11Code>81033-0002-40</NDC11Code>
<ProductNDC>81033-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains due to: 1 headaches, 2 backaches, 3 toothaches, 4 muscular aches, 5 minor pain of arthritis, 6 the common cold, 7 premenstrual and menstrual cramps, 8 sore throat, 9 flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81033-002-41</NDCCode>
<PackageDescription>8 CARTON in 1 CASE (81033-002-41) / 40 CUP, UNIT-DOSE in 1 CARTON (81033-002-40) / 10.15 mL in 1 CUP, UNIT-DOSE (81033-002-10) </PackageDescription>
<NDC11Code>81033-0002-41</NDC11Code>
<ProductNDC>81033-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81033-002-50</NDCCode>
<PackageDescription>50 CUP, UNIT-DOSE in 1 CARTON (81033-002-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-002-05) </PackageDescription>
<NDC11Code>81033-0002-50</NDC11Code>
<ProductNDC>81033-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains due to: 1 headaches, 2 backaches, 3 toothaches, 4 muscular aches, 5 minor pain of arthritis, 6 the common cold, 7 premenstrual and menstrual cramps, 8 sore throat, 9 flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81033-002-51</NDCCode>
<PackageDescription>8 CARTON in 1 CASE (81033-002-51) / 50 CUP, UNIT-DOSE in 1 CARTON (81033-002-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-002-05) </PackageDescription>
<NDC11Code>81033-0002-51</NDC11Code>
<ProductNDC>81033-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
</NDC>
</NDCList>