{
"NDC": [
{
"NDCCode": "58181-3043-5",
"PackageDescription": "1 BOTTLE in 1 CARTON (58181-3043-5) > 5 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "58181-3043-05",
"ProductNDC": "58181-3043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gleostine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151105",
"EndMarketingDate": "20180630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "NextSource Biotechnology, LLC",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151105",
"EndMarketingDatePackage": "20180630",
"SamplePackage": "N"
},
{
"NDCCode": "0220-3043-41",
"PackageDescription": "5 [hp_C] in 1 TUBE (0220-3043-41) ",
"NDC11Code": "00220-3043-41",
"ProductNDC": "0220-3043",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ledum Palustre",
"NonProprietaryName": "Rhododendron Tomentosum Leafy Twig",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "RHODODENDRON TOMENTOSUM LEAFY TWIG",
"StrengthNumber": "5",
"StrengthUnit": "[hp_C]/5[hp_C]",
"Status": "Active",
"LastUpdate": "2023-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Insect bites or bruising*."
},
{
"NDCCode": "36987-3043-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-3043-1)",
"NDC11Code": "36987-3043-01",
"ProductNDC": "36987-3043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sweet Gum",
"NonProprietaryName": "Sweet Gum",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "LIQUIDAMBAR STYRACIFLUA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "38779-3043-3",
"PackageDescription": "5 g in 1 BOTTLE (38779-3043-3) ",
"NDC11Code": "38779-3043-03",
"ProductNDC": "38779-3043",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Desonide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20171012",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "MEDISCA Inc.",
"SubstanceName": "DESONIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-05-31",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "12-OCT-17"
},
{
"NDCCode": "48951-3043-5",
"PackageDescription": "60 g in 1 TUBE (48951-3043-5)",
"NDC11Code": "48951-3043-05",
"ProductNDC": "48951-3043",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cartilago Quartz",
"NonProprietaryName": "Cartilago Quartz",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "BEEF; ECHINACEA, UNSPECIFIED; SILICON DIOXIDE",
"StrengthNumber": "30; 2; 30",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Directions: FOR TOPICAL USE ONLY."
},
{
"NDCCode": "54569-3043-5",
"PackageDescription": "14 TABLET in 1 BOTTLE (54569-3043-5)",
"NDC11Code": "54569-3043-05",
"ProductNDC": "54569-3043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19740226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083677",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54868-3043-5",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (54868-3043-5)",
"NDC11Code": "54868-3043-05",
"ProductNDC": "54868-3043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078314",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.",
"Description": "Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544."
},
{
"NDCCode": "63629-3043-5",
"PackageDescription": "180 TABLET in 1 BOTTLE (63629-3043-5) ",
"NDC11Code": "63629-3043-05",
"ProductNDC": "63629-3043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077091",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2020-08-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100623",
"SamplePackage": "N",
"IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
"Description": "Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water. The structural formula is. Glimepiride tablets meets USP drug release test 2. Glimepiride tablets USP, contain the active ingredient glimepiride USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake)."
},
{
"NDCCode": "58181-3030-5",
"PackageDescription": "5 CAPSULE, GELATIN COATED in 1 BOTTLE (58181-3030-5)",
"NDC11Code": "58181-3030-05",
"ProductNDC": "58181-3030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lomustine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "NextSource Biotechnology, LLC",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "58181-3031-5",
"PackageDescription": "5 CAPSULE, GELATIN COATED in 1 BOTTLE (58181-3031-5)",
"NDC11Code": "58181-3031-05",
"ProductNDC": "58181-3031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lomustine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "NextSource Biotechnology, LLC",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "58181-3032-5",
"PackageDescription": "5 CAPSULE, GELATIN COATED in 1 BOTTLE (58181-3032-5)",
"NDC11Code": "58181-3032-05",
"ProductNDC": "58181-3032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lomustine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "NextSource Biotechnology, LLC",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "58181-3040-5",
"PackageDescription": "1 BOTTLE in 1 CARTON (58181-3040-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "58181-3040-05",
"ProductNDC": "58181-3040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gleostine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "NextSource Biotechnology, LLC",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140818",
"SamplePackage": "N",
"IndicationAndUsage": "Gleostine is an alkylating drug indicated for the treatment of patients with: 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1) .",
"Description": "Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C 9H 16ClN 3O 2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is. Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2."
},
{
"NDCCode": "58181-3041-5",
"PackageDescription": "1 BOTTLE in 1 CARTON (58181-3041-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "58181-3041-05",
"ProductNDC": "58181-3041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gleostine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "NextSource Biotechnology, LLC",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140818",
"SamplePackage": "N",
"IndicationAndUsage": "Gleostine is an alkylating drug indicated for the treatment of patients with: 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1) .",
"Description": "Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C 9H 16ClN 3O 2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is. Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2."
},
{
"NDCCode": "58181-3042-5",
"PackageDescription": "1 BOTTLE in 1 CARTON (58181-3042-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "58181-3042-05",
"ProductNDC": "58181-3042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gleostine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "NextSource Biotechnology, LLC",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140818",
"SamplePackage": "N",
"IndicationAndUsage": "Gleostine is an alkylating drug indicated for the treatment of patients with: 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1) .",
"Description": "Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C 9H 16ClN 3O 2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is. Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2."
},
{
"NDCCode": "58181-4102-5",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (58181-4102-5) ",
"NDC11Code": "58181-4102-05",
"ProductNDC": "58181-4102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclophosphamide",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218282",
"LabelerName": "NextSource Pharma",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"Description": "Cyclophosphamide, USP is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide has a molecular formula C 7H 15Cl 2N 2O 2P H 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline and ethanol. Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide (anhydrous, USP) and the following inactive ingredients: Starch 1500 and sodium stearyl fumarate. Each gelatin capsule shell contains FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains Ferrosoferric oxide-black, propylene glycol and shellac. FDA approved dissolution test method differs from USP."
},
{
"NDCCode": "58181-4351-4",
"PackageDescription": "5 POUCH in 1 CARTON (58181-4351-4) / 1 CAPSULE in 1 POUCH",
"NDC11Code": "58181-4351-04",
"ProductNDC": "58181-4351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203898",
"LabelerName": "NextSource Biotechnology LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250401",
"SamplePackage": "N"
},
{
"NDCCode": "58181-7010-1",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 BOX (58181-7010-1) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "58181-7010-01",
"ProductNDC": "58181-7010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl",
"NonProprietaryName": "Lidocaine Hcl",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PARENTERAL",
"StartMarketingDate": "20240912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212821",
"LabelerName": "Nextsource Pharma",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
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"Description": "Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONSfor specific uses. The solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14H 22N 2O HCl) has the following structural formula:. Lidocaine Hydrochloride Injection, USP single dose solutions are methylparaben free. Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid."
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"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. C14H22N2O3 M.W. (free base) 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Each tablet, for oral administration, contains 25 mg, 50 mg or 100 mg of atenolol, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
"NDCCode": "57884-3043-1",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (57884-3043-1) / 8 mL in 1 VIAL, GLASS",
"NDC11Code": "57884-3043-01",
"ProductNDC": "57884-3043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207252",
"LabelerName": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "160",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170809",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5) .",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:. Docetaxel is a white to almost-white powder with an empirical formula of C 43H 53NO 14 3H 2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water."
},
{
"NDCCode": "59630-266-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01) ",
"NDC11Code": "59630-0266-10",
"ProductNDC": "59630-266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fetroja",
"NonProprietaryName": "Cefiderocol Sulfate Tosylate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209445",
"LabelerName": "Shionogi Inc.",
"SubstanceName": "CEFIDEROCOL SULFATE TOSYLATE",
"StrengthNumber": "1",
"StrengthUnit": "g/10mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200131",
"SamplePackage": "N",
"IndicationAndUsage": "FETROJA is a cephalosporin antibacterial indicated in patients 18 years of age or older for the treatment of the following infections caused by susceptible Gram-negative microorganisms: 1 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis ( 1.1) , 2 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) ( 1.2) .",
"Description": "FETROJA is a cephalosporin antibacterial drug product consisting of cefiderocol sulfate tosylate for intravenous infusion. Cefiderocol functions as a siderophore [see Microbiology (12.4)] . The chemical name of cefiderocol sulfate tosylate is Tris[(6 R,7 R)-7-[(2 Z)-2-(2-amino-1,3-thiazol-4-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetamido]-3-({1-[2-(2-chloro-3,4-dihydroxybenzamido)ethyl]pyrrolidin-1-ium-1-yl}methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate] tetrakis(4-methylbenzenesulfonate) monosulfate hydrate, and the molecular weight is 3043.50 (anhydrous). The molecular formula is 3C 30H 34ClN 7O 10S 2∙4C 7H 8O 3S∙H 2SO 4∙xH 2O. FETROJA for injection is a white to off-white, sterile, lyophilized powder formulated with 1 gram of cefiderocol (equivalent to 1.6 grams of cefiderocol sulfate tosylate), sucrose (900 mg), sodium chloride (216 mg), and sodium hydroxide to adjust pH. The sodium content is approximately 176 mg/vial. The pH of the reconstituted solution of 1 gram cefiderocol (1 vial) dissolved in 10 mL water is 5.2 to 5.8."
},
{
"NDCCode": "58181-4115-0",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (58181-4115-0) ",
"NDC11Code": "58181-4115-00",
"ProductNDC": "58181-4115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclophosphamide",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218282",
"LabelerName": "NextSource Pharma",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"Description": "Cyclophosphamide, USP is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide has a molecular formula C 7H 15Cl 2N 2O 2P H 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline and ethanol. Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide (anhydrous, USP) and the following inactive ingredients: Starch 1500 and sodium stearyl fumarate. Each gelatin capsule shell contains FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains Ferrosoferric oxide-black, propylene glycol and shellac. FDA approved dissolution test method differs from USP."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58181-3043-5</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58181-3043-5) > 5 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>58181-3043-05</NDC11Code>
<ProductNDC>58181-3043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gleostine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151105</StartMarketingDate>
<EndMarketingDate>20180630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>NextSource Biotechnology, LLC</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151105</StartMarketingDatePackage>
<EndMarketingDatePackage>20180630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0220-3043-41</NDCCode>
<PackageDescription>5 [hp_C] in 1 TUBE (0220-3043-41) </PackageDescription>
<NDC11Code>00220-3043-41</NDC11Code>
<ProductNDC>0220-3043</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ledum Palustre</ProprietaryName>
<NonProprietaryName>Rhododendron Tomentosum Leafy Twig</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>RHODODENDRON TOMENTOSUM LEAFY TWIG</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[hp_C]/5[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Insect bites or bruising*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-3043-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-3043-1)</PackageDescription>
<NDC11Code>36987-3043-01</NDC11Code>
<ProductNDC>36987-3043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sweet Gum</ProprietaryName>
<NonProprietaryName>Sweet Gum</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>LIQUIDAMBAR STYRACIFLUA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>38779-3043-3</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (38779-3043-3) </PackageDescription>
<NDC11Code>38779-3043-03</NDC11Code>
<ProductNDC>38779-3043</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Desonide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20171012</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>MEDISCA Inc.</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-31</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-OCT-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>48951-3043-5</NDCCode>
<PackageDescription>60 g in 1 TUBE (48951-3043-5)</PackageDescription>
<NDC11Code>48951-3043-05</NDC11Code>
<ProductNDC>48951-3043</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cartilago Quartz</ProprietaryName>
<NonProprietaryName>Cartilago Quartz</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>BEEF; ECHINACEA, UNSPECIFIED; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>30; 2; 30</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: FOR TOPICAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54569-3043-5</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (54569-3043-5)</PackageDescription>
<NDC11Code>54569-3043-05</NDC11Code>
<ProductNDC>54569-3043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19740226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083677</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-3043-5</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (54868-3043-5)</PackageDescription>
<NDC11Code>54868-3043-05</NDC11Code>
<ProductNDC>54868-3043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078314</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.</IndicationAndUsage>
<Description>Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544.</Description>
</NDC>
<NDC>
<NDCCode>63629-3043-5</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (63629-3043-5) </PackageDescription>
<NDC11Code>63629-3043-05</NDC11Code>
<ProductNDC>63629-3043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077091</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
<Description>Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water. The structural formula is. Glimepiride tablets meets USP drug release test 2. Glimepiride tablets USP, contain the active ingredient glimepiride USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake).</Description>
</NDC>
<NDC>
<NDCCode>58181-3030-5</NDCCode>
<PackageDescription>5 CAPSULE, GELATIN COATED in 1 BOTTLE (58181-3030-5)</PackageDescription>
<NDC11Code>58181-3030-05</NDC11Code>
<ProductNDC>58181-3030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lomustine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>NextSource Biotechnology, LLC</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>58181-3031-5</NDCCode>
<PackageDescription>5 CAPSULE, GELATIN COATED in 1 BOTTLE (58181-3031-5)</PackageDescription>
<NDC11Code>58181-3031-05</NDC11Code>
<ProductNDC>58181-3031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lomustine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>NextSource Biotechnology, LLC</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>58181-3032-5</NDCCode>
<PackageDescription>5 CAPSULE, GELATIN COATED in 1 BOTTLE (58181-3032-5)</PackageDescription>
<NDC11Code>58181-3032-05</NDC11Code>
<ProductNDC>58181-3032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lomustine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>NextSource Biotechnology, LLC</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>58181-3040-5</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58181-3040-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>58181-3040-05</NDC11Code>
<ProductNDC>58181-3040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gleostine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>NextSource Biotechnology, LLC</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gleostine is an alkylating drug indicated for the treatment of patients with: 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1) .</IndicationAndUsage>
<Description>Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C 9H 16ClN 3O 2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is. Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2.</Description>
</NDC>
<NDC>
<NDCCode>58181-3041-5</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58181-3041-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>58181-3041-05</NDC11Code>
<ProductNDC>58181-3041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gleostine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>NextSource Biotechnology, LLC</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gleostine is an alkylating drug indicated for the treatment of patients with: 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1) .</IndicationAndUsage>
<Description>Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C 9H 16ClN 3O 2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is. Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2.</Description>
</NDC>
<NDC>
<NDCCode>58181-3042-5</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58181-3042-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>58181-3042-05</NDC11Code>
<ProductNDC>58181-3042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gleostine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>NextSource Biotechnology, LLC</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gleostine is an alkylating drug indicated for the treatment of patients with: 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1) .</IndicationAndUsage>
<Description>Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C 9H 16ClN 3O 2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is. Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2.</Description>
</NDC>
<NDC>
<NDCCode>58181-4102-5</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (58181-4102-5) </PackageDescription>
<NDC11Code>58181-4102-05</NDC11Code>
<ProductNDC>58181-4102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclophosphamide</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218282</ApplicationNumber>
<LabelerName>NextSource Pharma</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Cyclophosphamide, USP is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide has a molecular formula C 7H 15Cl 2N 2O 2P H 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline and ethanol. Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide (anhydrous, USP) and the following inactive ingredients: Starch 1500 and sodium stearyl fumarate. Each gelatin capsule shell contains FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains Ferrosoferric oxide-black, propylene glycol and shellac. FDA approved dissolution test method differs from USP.</Description>
</NDC>
<NDC>
<NDCCode>58181-4351-4</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (58181-4351-4) / 1 CAPSULE in 1 POUCH</PackageDescription>
<NDC11Code>58181-4351-04</NDC11Code>
<ProductNDC>58181-4351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203898</ApplicationNumber>
<LabelerName>NextSource Biotechnology LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58181-7010-1</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 BOX (58181-7010-1) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>58181-7010-01</NDC11Code>
<ProductNDC>58181-7010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PARENTERAL</RouteName>
<StartMarketingDate>20240912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212821</ApplicationNumber>
<LabelerName>Nextsource Pharma</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONSfor specific uses. The solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14H 22N 2O HCl) has the following structural formula:. Lidocaine Hydrochloride Injection, USP single dose solutions are methylparaben free. Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>58181-7025-1</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 BOX (58181-7025-1) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>58181-7025-01</NDC11Code>
<ProductNDC>58181-7025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PARENTERAL</RouteName>
<StartMarketingDate>20240912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212821</ApplicationNumber>
<LabelerName>Nextsource Pharma</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONSfor specific uses. The solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14H 22N 2O HCl) has the following structural formula:. Lidocaine Hydrochloride Injection, USP single dose solutions are methylparaben free. Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>58181-8010-2</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 BOX (58181-8010-2) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>58181-8010-02</NDC11Code>
<ProductNDC>58181-8010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PARENTERAL</RouteName>
<StartMarketingDate>20240912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212821</ApplicationNumber>
<LabelerName>Nextsource Pharma</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONSfor specific uses. The solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14H 22N 2O HCl) has the following structural formula:. Lidocaine Hydrochloride Injection, USP single dose solutions are methylparaben free. Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>58181-8025-2</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 BOX (58181-8025-2) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>58181-8025-02</NDC11Code>
<ProductNDC>58181-8025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PARENTERAL</RouteName>
<StartMarketingDate>20240912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212821</ApplicationNumber>
<LabelerName>Nextsource Pharma</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONSfor specific uses. The solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14H 22N 2O HCl) has the following structural formula:. Lidocaine Hydrochloride Injection, USP single dose solutions are methylparaben free. Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>0074-3043-13</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0074-3043-13) </PackageDescription>
<NDC11Code>00074-3043-13</NDC11Code>
<ProductNDC>0074-3043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vicodin</ProprietaryName>
<ProprietaryNameSuffix>Es</ProprietaryNameSuffix>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<EndMarketingDate>20191214</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040658</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120910</StartMarketingDatePackage>
<EndMarketingDatePackage>20190801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-3043-53</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0074-3043-53) </PackageDescription>
<NDC11Code>00074-3043-53</NDC11Code>
<ProductNDC>0074-3043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vicodin</ProprietaryName>
<ProprietaryNameSuffix>Es</ProprietaryNameSuffix>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<EndMarketingDate>20191214</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040658</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120910</StartMarketingDatePackage>
<EndMarketingDatePackage>20191214</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-3043-0</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50090-3043-0) </PackageDescription>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19950222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074056</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. C14H22N2O3 M.W. (free base) 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Each tablet, for oral administration, contains 25 mg, 50 mg or 100 mg of atenolol, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20170802</StartMarketingDatePackage>
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<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. C14H22N2O3 M.W. (free base) 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Each tablet, for oral administration, contains 25 mg, 50 mg or 100 mg of atenolol, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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<ApplicationNumber>ANDA074056</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
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<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. C14H22N2O3 M.W. (free base) 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Each tablet, for oral administration, contains 25 mg, 50 mg or 100 mg of atenolol, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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<NDCCode>50090-3043-7</NDCCode>
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<ProprietaryName>Atenolol</ProprietaryName>
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<StartMarketingDate>19950222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074056</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. C14H22N2O3 M.W. (free base) 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Each tablet, for oral administration, contains 25 mg, 50 mg or 100 mg of atenolol, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>50090-3043-8</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-3043-8) </PackageDescription>
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<ProprietaryName>Atenolol</ProprietaryName>
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<ApplicationNumber>ANDA074056</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. C14H22N2O3 M.W. (free base) 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Each tablet, for oral administration, contains 25 mg, 50 mg or 100 mg of atenolol, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>57884-3043-1</NDCCode>
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<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207252</ApplicationNumber>
<LabelerName>Jiangsu Hengrui Pharmaceuticals Co., Ltd.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5) .</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:. Docetaxel is a white to almost-white powder with an empirical formula of C 43H 53NO 14 3H 2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water.</Description>
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<NDC>
<NDCCode>59630-266-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fetroja</ProprietaryName>
<NonProprietaryName>Cefiderocol Sulfate Tosylate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209445</ApplicationNumber>
<LabelerName>Shionogi Inc.</LabelerName>
<SubstanceName>CEFIDEROCOL SULFATE TOSYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FETROJA is a cephalosporin antibacterial indicated in patients 18 years of age or older for the treatment of the following infections caused by susceptible Gram-negative microorganisms: 1 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis ( 1.1) , 2 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) ( 1.2) .</IndicationAndUsage>
<Description>FETROJA is a cephalosporin antibacterial drug product consisting of cefiderocol sulfate tosylate for intravenous infusion. Cefiderocol functions as a siderophore [see Microbiology (12.4)] . The chemical name of cefiderocol sulfate tosylate is Tris[(6 R,7 R)-7-[(2 Z)-2-(2-amino-1,3-thiazol-4-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetamido]-3-({1-[2-(2-chloro-3,4-dihydroxybenzamido)ethyl]pyrrolidin-1-ium-1-yl}methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate] tetrakis(4-methylbenzenesulfonate) monosulfate hydrate, and the molecular weight is 3043.50 (anhydrous). The molecular formula is 3C 30H 34ClN 7O 10S 2∙4C 7H 8O 3S∙H 2SO 4∙xH 2O. FETROJA for injection is a white to off-white, sterile, lyophilized powder formulated with 1 gram of cefiderocol (equivalent to 1.6 grams of cefiderocol sulfate tosylate), sucrose (900 mg), sodium chloride (216 mg), and sodium hydroxide to adjust pH. The sodium content is approximately 176 mg/vial. The pH of the reconstituted solution of 1 gram cefiderocol (1 vial) dissolved in 10 mL water is 5.2 to 5.8.</Description>
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<NDCCode>58181-4115-0</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (58181-4115-0) </PackageDescription>
<NDC11Code>58181-4115-00</NDC11Code>
<ProductNDC>58181-4115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclophosphamide</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218282</ApplicationNumber>
<LabelerName>NextSource Pharma</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Cyclophosphamide, USP is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide has a molecular formula C 7H 15Cl 2N 2O 2P H 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline and ethanol. Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide (anhydrous, USP) and the following inactive ingredients: Starch 1500 and sodium stearyl fumarate. Each gelatin capsule shell contains FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains Ferrosoferric oxide-black, propylene glycol and shellac. FDA approved dissolution test method differs from USP.</Description>
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