{
"NDC": [
{
"NDCCode": "69945-120-56",
"PackageDescription": "1 VIAL in 1 CAN (69945-120-56) / 5.6 mL in 1 VIAL",
"NDC11Code": "69945-0120-56",
"ProductNDC": "69945-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thallous Chloride Tl 201",
"NonProprietaryName": "Thallous Chloride, Tl 201",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018150",
"LabelerName": "Curium US LLC",
"SubstanceName": "THALLOUS CHLORIDE TL-201",
"StrengthNumber": "1",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151104",
"SamplePackage": "N",
"IndicationAndUsage": "Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: 1 Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction)Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress, 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels.",
"Description": "Thallous Chloride Tl 201 Injection is a sterile, radioactive diagnostic drug for intravenous use. Each mL contains 37 MBq (1 mCi) thallous chloride Tl 201 at calibration time and the following inactive ingredients: 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium-201 is cyclotron produced. At the time of calibration it contains no more than 1% thallium-200, no more than 1% thallium-202, no more than 0.25% lead-203, and no less than 98% thallium-201 as a percentage of total activity. No carrier has been added. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of thallium-200 (Tl 200) and thallium-202 (Tl 202) radionuclidic contaminants as a function of time. Figure 1. Radionuclidic Contaminants."
},
{
"NDCCode": "69945-120-28",
"PackageDescription": "1 VIAL in 1 CAN (69945-120-28) / 2.8 mL in 1 VIAL",
"NDC11Code": "69945-0120-28",
"ProductNDC": "69945-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thallous Chloride Tl 201",
"NonProprietaryName": "Thallous Chloride, Tl 201",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018150",
"LabelerName": "Curium US LLC",
"SubstanceName": "THALLOUS CHLORIDE TL-201",
"StrengthNumber": "1",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151104",
"SamplePackage": "N",
"IndicationAndUsage": "Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for: 1 Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress., 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.",
"Description": "Thallous Chloride Tl 201 Injection is supplied in an isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 at calibration time, made isotonic with 9 milligrams sodium chloride and preserved with 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium Tl-201 is cyclotron produced. At the time of calibration it contains no more than 1.0% thallium Tl-200, no more than 1.0% thallium Tl-202, no more than 0.25% lead Pb-203, and no less than 98% thallium Tl-201 as a percentage of total activity. No carrier has been added. It is recommended to administer Thallous Chloride Tl 201 Injection close to calibration time to minimize the effect of higher levels of radionuclidic contaminants present at pre- and post-calibration dates. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of each radionuclidic contaminant as a function of time. Figure 1. Radionuclidic Contaminants."
},
{
"NDCCode": "69945-120-63",
"PackageDescription": "1 VIAL in 1 CAN (69945-120-63) / 6.3 mL in 1 VIAL",
"NDC11Code": "69945-0120-63",
"ProductNDC": "69945-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thallous Chloride Tl 201",
"NonProprietaryName": "Thallous Chloride, Tl 201",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018150",
"LabelerName": "Curium US LLC",
"SubstanceName": "THALLOUS CHLORIDE TL-201",
"StrengthNumber": "1",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151104",
"SamplePackage": "N",
"IndicationAndUsage": "Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for: 1 Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress., 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.",
"Description": "Thallous Chloride Tl 201 Injection is supplied in an isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 at calibration time, made isotonic with 9 milligrams sodium chloride and preserved with 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium Tl-201 is cyclotron produced. At the time of calibration it contains no more than 1.0% thallium Tl-200, no more than 1.0% thallium Tl-202, no more than 0.25% lead Pb-203, and no less than 98% thallium Tl-201 as a percentage of total activity. No carrier has been added. It is recommended to administer Thallous Chloride Tl 201 Injection close to calibration time to minimize the effect of higher levels of radionuclidic contaminants present at pre- and post-calibration dates. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of each radionuclidic contaminant as a function of time. Figure 1. Radionuclidic Contaminants."
},
{
"NDCCode": "69945-120-99",
"PackageDescription": "1 VIAL in 1 CAN (69945-120-99) / 9.9 mL in 1 VIAL",
"NDC11Code": "69945-0120-99",
"ProductNDC": "69945-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thallous Chloride Tl 201",
"NonProprietaryName": "Thallous Chloride, Tl 201",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018150",
"LabelerName": "Curium US LLC",
"SubstanceName": "THALLOUS CHLORIDE TL-201",
"StrengthNumber": "1",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151104",
"SamplePackage": "N",
"IndicationAndUsage": "Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for: 1 Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress., 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.",
"Description": "Thallous Chloride Tl 201 Injection is supplied in an isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 at calibration time, made isotonic with 9 milligrams sodium chloride and preserved with 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium Tl-201 is cyclotron produced. At the time of calibration it contains no more than 1.0% thallium Tl-200, no more than 1.0% thallium Tl-202, no more than 0.25% lead Pb-203, and no less than 98% thallium Tl-201 as a percentage of total activity. No carrier has been added. It is recommended to administer Thallous Chloride Tl 201 Injection close to calibration time to minimize the effect of higher levels of radionuclidic contaminants present at pre- and post-calibration dates. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of each radionuclidic contaminant as a function of time. Figure 1. Radionuclidic Contaminants."
},
{
"NDCCode": "10356-120-07",
"PackageDescription": "56 g in 1 TUBE (10356-120-07) ",
"NDC11Code": "10356-0120-07",
"ProductNDC": "10356-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquaphor Itch Relief",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to. eczema insect bites soaps poison ivy, oak, sumac seborrheic dermatitis psoriasis detergents cosmetics jewelry."
},
{
"NDCCode": "10356-120-54",
"PackageDescription": "1 TUBE in 1 CARTON (10356-120-54) / 56 g in 1 TUBE (10356-120-07) ",
"NDC11Code": "10356-0120-54",
"ProductNDC": "10356-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquaphor Itch Relief",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to. eczema insect bites soaps poison ivy, oak, sumac seborrheic dermatitis psoriasis detergents cosmetics jewelry."
},
{
"NDCCode": "57627-120-01",
"PackageDescription": "56 g in 1 JAR (57627-120-01)",
"NDC11Code": "57627-0120-01",
"ProductNDC": "57627-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Merle Norman",
"ProprietaryNameSuffix": "Preventage Firming Defense Normal/oily Broad Spectrum Spf 15",
"NonProprietaryName": "Avobenzone, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Merle Norman Cosmetics, Inc",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "1.064; 5.264",
"StrengthUnit": "g/56g; g/56g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0032-1206-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (0032-1206-56) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE",
"NDC11Code": "00032-1206-56",
"ProductNDC": "0032-1206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "30000; 6000; 19000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090430",
"SamplePackage": "Y",
"IndicationAndUsage": "CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
"Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0093-9224-89",
"PackageDescription": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89) ",
"NDC11Code": "00093-9224-89",
"ProductNDC": "0093-9224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210105",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022301",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210105",
"SamplePackage": "N",
"IndicationAndUsage": "Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.",
"Description": "Each mesalamine extended-release capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each mesalamine extended-release 0.375 g capsule contains 0.56 mg of phenylalanine."
},
{
"NDCCode": "13733-120-01",
"PackageDescription": "14 g in 1 CARTON (13733-120-01)",
"NDC11Code": "13733-0120-01",
"ProductNDC": "13733-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha Signature Essence Cushion No 23",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Able C&C Co., Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "1.24; .93; .56",
"StrengthUnit": "g/14g; g/14g; g/14g",
"Status": "Deprecated",
"LastUpdate": "2018-10-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55513-488-02",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01) ",
"NDC11Code": "55513-0488-02",
"ProductNDC": "55513-488",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "55513-488-24",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55513-488-24) / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40) ",
"NDC11Code": "55513-0488-24",
"ProductNDC": "55513-488",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "55513-488-96",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55513-0488-96",
"ProductNDC": "55513-488",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "Y",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "55513-504-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55513-504-50) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55513-0504-50",
"ProductNDC": "55513-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230202",
"SamplePackage": "N",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "55513-512-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55513-512-60) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55513-0512-60",
"ProductNDC": "55513-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240627",
"SamplePackage": "N",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "63629-8827-1",
"PackageDescription": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8827-1) ",
"NDC11Code": "63629-8827-01",
"ProductNDC": "63629-8827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210105",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022301",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240708",
"SamplePackage": "N",
"IndicationAndUsage": "Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.",
"Description": "Each mesalamine extended-release capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each mesalamine extended-release 0.375 g capsule contains 0.56 mg of phenylalanine."
},
{
"NDCCode": "65219-120-12",
"PackageDescription": "1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL",
"NDC11Code": "65219-0120-12",
"ProductNDC": "65219-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dalbavancin Hydrochloride",
"NonProprietaryName": "Dalbavancin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217591",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DALBAVANCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251110",
"SamplePackage": "N",
"IndicationAndUsage": "Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram- positive microorganisms. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).",
"Description": "Dalbavancin for injection is a lipoglycopeptide antibacterial synthesized from a fermentation product of Nonomuraea species. Dalbavancin is a mixture of five closely related active homologs (A0, A1, B0, B1, and B2); the component B0 is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R1) structure and/or the presence of an additional methyl group (R2) on the terminal amino group (shown in the Figure 1 and Table 3 below). The B0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O- [2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride. Dalbavancin for injection is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for IV infusion [see Dosage and Administration (2.4), How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "65649-103-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "65649-0103-02",
"ProductNDC": "65649-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apriso",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20081031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022301",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20081031",
"SamplePackage": "N",
"IndicationAndUsage": "APRISO ®is indicated for the maintenance of remission of ulcerative colitis in adults.",
"Description": "Each APRISO ®capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is:. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of APRISO capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine."
},
{
"NDCCode": "66621-0790-2",
"PackageDescription": "1 VIAL in 1 CARTON (66621-0790-2) / 10 mL in 1 VIAL (66621-0790-1) ",
"NDC11Code": "66621-0790-02",
"ProductNDC": "66621-0790",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Anavip",
"NonProprietaryName": "Crotalidae Immune F(ab)2(equine)",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150506",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125488",
"LabelerName": "Rare Disease Therapeutics, Inc",
"SubstanceName": "PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "12",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150506",
"SamplePackage": "N",
"IndicationAndUsage": "ANAVIP [crotalidae immune F(ab')2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation. (1).",
"Description": "ANAVIP [crotalidae immune F(ab')2 (equine)] is a sterile, lyophilized, polyvalent preparation of equine immunoglobulin F(ab')2 fragments, manufactured from the plasma of horses immunized with venom of Bothrops asper and Crotalus simus (formerly Crotalus durissus). The product is obtained by pepsin digestion of horse plasma to remove the Fc portion of immunoglobulin, followed by fractionation and purification steps. The F(ab')2 content is not less than 85%, F(ab') content is not more than 7%, and the product contains less than 5% intact immunoglobulin. Each vial of ANAVIP contains 25.2-56.8 mg of sodium chloride, 47.30 - 91.35 mg of sucrose, and 95.03-183.15 mg of glycine as stabilizers. Trace amounts of pepsin (≤50 ng/vial), cresol (≤0.058 mg/vial), borates (≤1 mg/vial), and sulfates (≤1.7 mg/vial) may be present from the manufacturing process. Each vial contains no more than 120 mg of protein and will be neutralize not less than 780 times the LD50 of Bothrops asper (Terciopelo or fer-de-lance) venom, 790 times the LD50 of Crotalus simus (formerly Crotalus durissus) (Central American Rattlesnake) venom, 244 times the LD50 of Crotalus adamanteus (Eastern Diamondback Rattlesnake) venom, 147 times the LD50 of Crotalus atrox (Western Diamondback Rattlesnake) venom, 185 times the LD50 of Crotalus scutulatus (Mohave Rattlesnake) venom, 28 times the LD50 of Agkistrodon contortrix (Copperhead) venom and 61 times the LD50 of Agkistrodon piscivorus (Cottonmouth or Water Moccasin) venom in a mouse neutralization assay.The manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment and nanofiltration."
},
{
"NDCCode": "67544-224-56",
"PackageDescription": "3000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-56) ",
"NDC11Code": "67544-0224-56",
"ProductNDC": "67544-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075155",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130628",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane."
},
{
"NDCCode": "67544-236-56",
"PackageDescription": "3000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-236-56) ",
"NDC11Code": "67544-0236-56",
"ProductNDC": "67544-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075155",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140206",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane."
},
{
"NDCCode": "68071-4545-2",
"PackageDescription": "120 TABLET in 1 BOTTLE (68071-4545-2) ",
"NDC11Code": "68071-4545-02",
"ProductNDC": "68071-4545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070925",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180828",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets USP contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. C 9H 9Cl 2N 3 HCl Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "68682-113-20",
"PackageDescription": "1 BOTTLE in 1 CARTON (68682-113-20) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "68682-0113-20",
"ProductNDC": "68682-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180719",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022301",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180719",
"SamplePackage": "N",
"IndicationAndUsage": "Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.",
"Description": "Each mesalamine extended-release capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each mesalamine extended-release 0.375 g capsule contains 0.56 mg of phenylalanine."
},
{
"NDCCode": "68788-6326-8",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-6326-8) ",
"NDC11Code": "68788-6326-08",
"ProductNDC": "68788-6326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090074",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161018",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole is a proton pump inhibitor (PPI) indicated for the following: 1 Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1), 2 Maintenance of Healing of Erosive Esophagitis (1.2), 3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3).",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl] -1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate, USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablet, USP contains the following inactive ingredients: calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 3."
},
{
"NDCCode": "68788-6429-8",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68788-6429-8) ",
"NDC11Code": "68788-6429-08",
"ProductNDC": "68788-6429",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160628",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "68788-6835-8",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68788-6835-8) ",
"NDC11Code": "68788-6835-08",
"ProductNDC": "68788-6835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161121",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "68788-7813-8",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68788-7813-8) ",
"NDC11Code": "68788-7813-08",
"ProductNDC": "68788-7813",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201504",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201030",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "68788-7950-8",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68788-7950-8) ",
"NDC11Code": "68788-7950-08",
"ProductNDC": "68788-7950",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201190",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210708",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1) , 2 Bipolar I disorder manic episodes (1.2) , 3 Bipolar disorder, depressive episodes (1.2) .",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl‑-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.10 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white powder which is insoluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are microcrystalline cellulose, colloidal silicon dioxide, silicon dioxide, crospovidone, anhydrous citric acid, polysorbate 80, magnesium stearate, lactose monohydrate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.12 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "68788-8669-8",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68788-8669-8) ",
"NDC11Code": "68788-8669-08",
"ProductNDC": "68788-8669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline",
"NonProprietaryName": "Sertraline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077670",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance."
},
{
"NDCCode": "68788-8745-8",
"PackageDescription": "120 TABLET in 1 BOTTLE (68788-8745-8) ",
"NDC11Code": "68788-8745-08",
"ProductNDC": "68788-8745",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201109",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240926",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2) .",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2.C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg film-coated tablet contains. 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg film-coated tablet contains 115.12 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg film-coated tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>69945-120-56</NDCCode>
<PackageDescription>1 VIAL in 1 CAN (69945-120-56) / 5.6 mL in 1 VIAL</PackageDescription>
<NDC11Code>69945-0120-56</NDC11Code>
<ProductNDC>69945-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thallous Chloride Tl 201</ProprietaryName>
<NonProprietaryName>Thallous Chloride, Tl 201</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018150</ApplicationNumber>
<LabelerName>Curium US LLC</LabelerName>
<SubstanceName>THALLOUS CHLORIDE TL-201</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: 1 Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction)Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress, 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels.</IndicationAndUsage>
<Description>Thallous Chloride Tl 201 Injection is a sterile, radioactive diagnostic drug for intravenous use. Each mL contains 37 MBq (1 mCi) thallous chloride Tl 201 at calibration time and the following inactive ingredients: 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium-201 is cyclotron produced. At the time of calibration it contains no more than 1% thallium-200, no more than 1% thallium-202, no more than 0.25% lead-203, and no less than 98% thallium-201 as a percentage of total activity. No carrier has been added. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of thallium-200 (Tl 200) and thallium-202 (Tl 202) radionuclidic contaminants as a function of time. Figure 1. Radionuclidic Contaminants.</Description>
</NDC>
<NDC>
<NDCCode>69945-120-28</NDCCode>
<PackageDescription>1 VIAL in 1 CAN (69945-120-28) / 2.8 mL in 1 VIAL</PackageDescription>
<NDC11Code>69945-0120-28</NDC11Code>
<ProductNDC>69945-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thallous Chloride Tl 201</ProprietaryName>
<NonProprietaryName>Thallous Chloride, Tl 201</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018150</ApplicationNumber>
<LabelerName>Curium US LLC</LabelerName>
<SubstanceName>THALLOUS CHLORIDE TL-201</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for: 1 Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress., 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.</IndicationAndUsage>
<Description>Thallous Chloride Tl 201 Injection is supplied in an isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 at calibration time, made isotonic with 9 milligrams sodium chloride and preserved with 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium Tl-201 is cyclotron produced. At the time of calibration it contains no more than 1.0% thallium Tl-200, no more than 1.0% thallium Tl-202, no more than 0.25% lead Pb-203, and no less than 98% thallium Tl-201 as a percentage of total activity. No carrier has been added. It is recommended to administer Thallous Chloride Tl 201 Injection close to calibration time to minimize the effect of higher levels of radionuclidic contaminants present at pre- and post-calibration dates. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of each radionuclidic contaminant as a function of time. Figure 1. Radionuclidic Contaminants.</Description>
</NDC>
<NDC>
<NDCCode>69945-120-63</NDCCode>
<PackageDescription>1 VIAL in 1 CAN (69945-120-63) / 6.3 mL in 1 VIAL</PackageDescription>
<NDC11Code>69945-0120-63</NDC11Code>
<ProductNDC>69945-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thallous Chloride Tl 201</ProprietaryName>
<NonProprietaryName>Thallous Chloride, Tl 201</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018150</ApplicationNumber>
<LabelerName>Curium US LLC</LabelerName>
<SubstanceName>THALLOUS CHLORIDE TL-201</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for: 1 Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress., 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.</IndicationAndUsage>
<Description>Thallous Chloride Tl 201 Injection is supplied in an isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 at calibration time, made isotonic with 9 milligrams sodium chloride and preserved with 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium Tl-201 is cyclotron produced. At the time of calibration it contains no more than 1.0% thallium Tl-200, no more than 1.0% thallium Tl-202, no more than 0.25% lead Pb-203, and no less than 98% thallium Tl-201 as a percentage of total activity. No carrier has been added. It is recommended to administer Thallous Chloride Tl 201 Injection close to calibration time to minimize the effect of higher levels of radionuclidic contaminants present at pre- and post-calibration dates. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of each radionuclidic contaminant as a function of time. Figure 1. Radionuclidic Contaminants.</Description>
</NDC>
<NDC>
<NDCCode>69945-120-99</NDCCode>
<PackageDescription>1 VIAL in 1 CAN (69945-120-99) / 9.9 mL in 1 VIAL</PackageDescription>
<NDC11Code>69945-0120-99</NDC11Code>
<ProductNDC>69945-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thallous Chloride Tl 201</ProprietaryName>
<NonProprietaryName>Thallous Chloride, Tl 201</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018150</ApplicationNumber>
<LabelerName>Curium US LLC</LabelerName>
<SubstanceName>THALLOUS CHLORIDE TL-201</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for: 1 Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress., 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.</IndicationAndUsage>
<Description>Thallous Chloride Tl 201 Injection is supplied in an isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 at calibration time, made isotonic with 9 milligrams sodium chloride and preserved with 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium Tl-201 is cyclotron produced. At the time of calibration it contains no more than 1.0% thallium Tl-200, no more than 1.0% thallium Tl-202, no more than 0.25% lead Pb-203, and no less than 98% thallium Tl-201 as a percentage of total activity. No carrier has been added. It is recommended to administer Thallous Chloride Tl 201 Injection close to calibration time to minimize the effect of higher levels of radionuclidic contaminants present at pre- and post-calibration dates. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of each radionuclidic contaminant as a function of time. Figure 1. Radionuclidic Contaminants.</Description>
</NDC>
<NDC>
<NDCCode>10356-120-07</NDCCode>
<PackageDescription>56 g in 1 TUBE (10356-120-07) </PackageDescription>
<NDC11Code>10356-0120-07</NDC11Code>
<ProductNDC>10356-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquaphor Itch Relief</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to. eczema insect bites soaps poison ivy, oak, sumac seborrheic dermatitis psoriasis detergents cosmetics jewelry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10356-120-54</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10356-120-54) / 56 g in 1 TUBE (10356-120-07) </PackageDescription>
<NDC11Code>10356-0120-54</NDC11Code>
<ProductNDC>10356-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquaphor Itch Relief</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to. eczema insect bites soaps poison ivy, oak, sumac seborrheic dermatitis psoriasis detergents cosmetics jewelry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57627-120-01</NDCCode>
<PackageDescription>56 g in 1 JAR (57627-120-01)</PackageDescription>
<NDC11Code>57627-0120-01</NDC11Code>
<ProductNDC>57627-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Merle Norman</ProprietaryName>
<ProprietaryNameSuffix>Preventage Firming Defense Normal/oily Broad Spectrum Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Merle Norman Cosmetics, Inc</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.064; 5.264</StrengthNumber>
<StrengthUnit>g/56g; g/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0032-1206-56</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0032-1206-56) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE</PackageDescription>
<NDC11Code>00032-1206-56</NDC11Code>
<ProductNDC>0032-1206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>30000; 6000; 19000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090430</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0093-9224-89</NDCCode>
<PackageDescription>120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89) </PackageDescription>
<NDC11Code>00093-9224-89</NDC11Code>
<ProductNDC>0093-9224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesalamine</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210105</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022301</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.</IndicationAndUsage>
<Description>Each mesalamine extended-release capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each mesalamine extended-release 0.375 g capsule contains 0.56 mg of phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>13733-120-01</NDCCode>
<PackageDescription>14 g in 1 CARTON (13733-120-01)</PackageDescription>
<NDC11Code>13733-0120-01</NDC11Code>
<ProductNDC>13733-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha Signature Essence Cushion No 23</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Able C&C Co., Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>1.24; .93; .56</StrengthNumber>
<StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55513-488-02</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01) </PackageDescription>
<NDC11Code>55513-0488-02</NDC11Code>
<ProductNDC>55513-488</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>55513-488-24</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55513-488-24) / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40) </PackageDescription>
<NDC11Code>55513-0488-24</NDC11Code>
<ProductNDC>55513-488</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>55513-488-96</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55513-0488-96</NDC11Code>
<ProductNDC>55513-488</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>55513-504-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55513-504-50) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55513-0504-50</NDC11Code>
<ProductNDC>55513-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>55513-512-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55513-512-60) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55513-0512-60</NDC11Code>
<ProductNDC>55513-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>63629-8827-1</NDCCode>
<PackageDescription>120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8827-1) </PackageDescription>
<NDC11Code>63629-8827-01</NDC11Code>
<ProductNDC>63629-8827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesalamine</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210105</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022301</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.</IndicationAndUsage>
<Description>Each mesalamine extended-release capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each mesalamine extended-release 0.375 g capsule contains 0.56 mg of phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>65219-120-12</NDCCode>
<PackageDescription>1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL</PackageDescription>
<NDC11Code>65219-0120-12</NDC11Code>
<ProductNDC>65219-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dalbavancin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dalbavancin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217591</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DALBAVANCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/25mL</StrengthUnit>
<Pharm_Classes>Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram- positive microorganisms. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).</IndicationAndUsage>
<Description>Dalbavancin for injection is a lipoglycopeptide antibacterial synthesized from a fermentation product of Nonomuraea species. Dalbavancin is a mixture of five closely related active homologs (A0, A1, B0, B1, and B2); the component B0 is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R1) structure and/or the presence of an additional methyl group (R2) on the terminal amino group (shown in the Figure 1 and Table 3 below). The B0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O- [2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride. Dalbavancin for injection is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for IV infusion [see Dosage and Administration (2.4), How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>65649-103-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>65649-0103-02</NDC11Code>
<ProductNDC>65649-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apriso</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022301</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APRISO ®is indicated for the maintenance of remission of ulcerative colitis in adults.</IndicationAndUsage>
<Description>Each APRISO ®capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is:. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of APRISO capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>66621-0790-2</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (66621-0790-2) / 10 mL in 1 VIAL (66621-0790-1) </PackageDescription>
<NDC11Code>66621-0790-02</NDC11Code>
<ProductNDC>66621-0790</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Anavip</ProprietaryName>
<NonProprietaryName>Crotalidae Immune F(ab)2(equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150506</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125488</ApplicationNumber>
<LabelerName>Rare Disease Therapeutics, Inc</LabelerName>
<SubstanceName>PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ANAVIP [crotalidae immune F(ab')2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation. (1).</IndicationAndUsage>
<Description>ANAVIP [crotalidae immune F(ab')2 (equine)] is a sterile, lyophilized, polyvalent preparation of equine immunoglobulin F(ab')2 fragments, manufactured from the plasma of horses immunized with venom of Bothrops asper and Crotalus simus (formerly Crotalus durissus). The product is obtained by pepsin digestion of horse plasma to remove the Fc portion of immunoglobulin, followed by fractionation and purification steps. The F(ab')2 content is not less than 85%, F(ab') content is not more than 7%, and the product contains less than 5% intact immunoglobulin. Each vial of ANAVIP contains 25.2-56.8 mg of sodium chloride, 47.30 - 91.35 mg of sucrose, and 95.03-183.15 mg of glycine as stabilizers. Trace amounts of pepsin (≤50 ng/vial), cresol (≤0.058 mg/vial), borates (≤1 mg/vial), and sulfates (≤1.7 mg/vial) may be present from the manufacturing process. Each vial contains no more than 120 mg of protein and will be neutralize not less than 780 times the LD50 of Bothrops asper (Terciopelo or fer-de-lance) venom, 790 times the LD50 of Crotalus simus (formerly Crotalus durissus) (Central American Rattlesnake) venom, 244 times the LD50 of Crotalus adamanteus (Eastern Diamondback Rattlesnake) venom, 147 times the LD50 of Crotalus atrox (Western Diamondback Rattlesnake) venom, 185 times the LD50 of Crotalus scutulatus (Mohave Rattlesnake) venom, 28 times the LD50 of Agkistrodon contortrix (Copperhead) venom and 61 times the LD50 of Agkistrodon piscivorus (Cottonmouth or Water Moccasin) venom in a mouse neutralization assay.The manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment and nanofiltration.</Description>
</NDC>
<NDC>
<NDCCode>67544-224-56</NDCCode>
<PackageDescription>3000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-56) </PackageDescription>
<NDC11Code>67544-0224-56</NDC11Code>
<ProductNDC>67544-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075155</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane.</Description>
</NDC>
<NDC>
<NDCCode>67544-236-56</NDCCode>
<PackageDescription>3000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-236-56) </PackageDescription>
<NDC11Code>67544-0236-56</NDC11Code>
<ProductNDC>67544-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075155</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane.</Description>
</NDC>
<NDC>
<NDCCode>68071-4545-2</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (68071-4545-2) </PackageDescription>
<NDC11Code>68071-4545-02</NDC11Code>
<ProductNDC>68071-4545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070925</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets USP contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. C 9H 9Cl 2N 3 HCl Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>68682-113-20</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68682-113-20) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>68682-0113-20</NDC11Code>
<ProductNDC>68682-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesalamine</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180719</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022301</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.</IndicationAndUsage>
<Description>Each mesalamine extended-release capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each mesalamine extended-release 0.375 g capsule contains 0.56 mg of phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>68788-6326-8</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-6326-8) </PackageDescription>
<NDC11Code>68788-6326-08</NDC11Code>
<ProductNDC>68788-6326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090074</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole is a proton pump inhibitor (PPI) indicated for the following: 1 Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1), 2 Maintenance of Healing of Erosive Esophagitis (1.2), 3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3).</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl] -1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate, USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablet, USP contains the following inactive ingredients: calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>68788-6429-8</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68788-6429-8) </PackageDescription>
<NDC11Code>68788-6429-08</NDC11Code>
<ProductNDC>68788-6429</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>68788-6835-8</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68788-6835-8) </PackageDescription>
<NDC11Code>68788-6835-08</NDC11Code>
<ProductNDC>68788-6835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>68788-7813-8</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68788-7813-8) </PackageDescription>
<NDC11Code>68788-7813-08</NDC11Code>
<ProductNDC>68788-7813</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201504</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>68788-7950-8</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68788-7950-8) </PackageDescription>
<NDC11Code>68788-7950-08</NDC11Code>
<ProductNDC>68788-7950</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201190</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1) , 2 Bipolar I disorder manic episodes (1.2) , 3 Bipolar disorder, depressive episodes (1.2) .</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl‑-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.10 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white powder which is insoluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are microcrystalline cellulose, colloidal silicon dioxide, silicon dioxide, crospovidone, anhydrous citric acid, polysorbate 80, magnesium stearate, lactose monohydrate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.12 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>68788-8669-8</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68788-8669-8) </PackageDescription>
<NDC11Code>68788-8669-08</NDC11Code>
<ProductNDC>68788-8669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline</ProprietaryName>
<NonProprietaryName>Sertraline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077670</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance.</Description>
</NDC>
<NDC>
<NDCCode>68788-8745-8</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (68788-8745-8) </PackageDescription>
<NDC11Code>68788-8745-08</NDC11Code>
<ProductNDC>68788-8745</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201109</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2) .</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2.C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg film-coated tablet contains. 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg film-coated tablet contains 115.12 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg film-coated tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
</NDCList>