{
"NDC": [
{
"NDCCode": "51552-0686-2",
"PackageDescription": "5 g in 1 CONTAINER (51552-0686-2)",
"NDC11Code": "51552-0686-02",
"ProductNDC": "51552-0686",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Meperidine Hcl",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51552-0686-1",
"PackageDescription": "1 g in 1 CONTAINER (51552-0686-1)",
"NDC11Code": "51552-0686-01",
"ProductNDC": "51552-0686",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Meperidine Hcl",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51552-0686-4",
"PackageDescription": "25 g in 1 CONTAINER (51552-0686-4) ",
"NDC11Code": "51552-0686-04",
"ProductNDC": "51552-0686",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Meperidine Hcl",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980401",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "29-FEB-12",
"EndMarketingDatePackage": "31-MAY-24"
},
{
"NDCCode": "11822-0686-4",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (11822-0686-4) > 2 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "11822-0686-04",
"ProductNDC": "11822-0686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laxative",
"ProprietaryNameSuffix": "Dye Free",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160331",
"EndMarketingDate": "20231211",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160331",
"EndMarketingDatePackage": "20231211",
"SamplePackage": "N"
},
{
"NDCCode": "37662-0686-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0686-2) ",
"NDC11Code": "37662-0686-02",
"ProductNDC": "37662-0686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eucalyptus Globulus",
"NonProprietaryName": "Eucalyptus Globulus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220621",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "EUCALYPTUS GLOBULUS LEAF",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220621",
"SamplePackage": "N"
},
{
"NDCCode": "50090-0686-2",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (50090-0686-2)",
"NDC11Code": "50090-0686-02",
"ProductNDC": "50090-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077856",
"LabelerName": "A-S Medication Solutions LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
},
{
"NDCCode": "66412-0686-2",
"PackageDescription": "500 g in 1 DRUM (66412-0686-2) ",
"NDC11Code": "66412-0686-02",
"ProductNDC": "66412-0686",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "VAMSI LABS LIMITED.",
"SubstanceName": "MOMETASONE FUROATE MONOHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-07-15",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "15-JUL-25"
},
{
"NDCCode": "68788-0686-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (68788-0686-2) ",
"NDC11Code": "68788-0686-02",
"ProductNDC": "68788-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diethylpropion Hcl Controlled-release",
"NonProprietaryName": "Diethylpropion Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140212",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012546",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "DIETHYLPROPION HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140212",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0686-1",
"PackageDescription": "2 TABLET in 1 BOTTLE (71335-0686-1) ",
"NDC11Code": "71335-0686-01",
"ProductNDC": "71335-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208963",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181106",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "71335-0686-2",
"PackageDescription": "14 TABLET in 1 BOTTLE (71335-0686-2) ",
"NDC11Code": "71335-0686-02",
"ProductNDC": "71335-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208963",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190312",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0078-0686-15",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0078-0686-15) ",
"NDC11Code": "00078-0686-15",
"ProductNDC": "0078-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022291",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "0078-0686-55",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (0078-0686-55) ",
"NDC11Code": "00078-0686-55",
"ProductNDC": "0078-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022291",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200121",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "0264-9567-10",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-9567-10) / 500 mL in 1 CONTAINER",
"NDC11Code": "00264-9567-10",
"ProductNDC": "0264-9567",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium In Dextrose",
"NonProprietaryName": "Heparin Sodium And Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19920720",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019952",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "HEPARIN SODIUM; DEXTROSE MONOHYDRATE",
"StrengthNumber": "4000; 5",
"StrengthUnit": "[USP'U]/100mL; g/100mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19920720",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium in 5% Dextrose Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism, 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, 3 Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation), 4 Prevention of clotting in arterial and cardiac surgery, 5 Prophylaxis and treatment of peripheral arterial embolism, 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
"Description": "Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of alpha-L-iduronic acid 2-sulfate (1), 2-deoxy-2-sulfamino- alpha-D-glucose 6-sulfate (2), beta-D-glucuronic acid (3), 2-acetamido-2- deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. The pH range is 5.6 (4.5 – 7.0) and the osmolarity mOsmol/L (calc.) is 315. The concentration of electrolytes is 38 mEq/L Sodium, 30 mEq/L Phosphate, and 15 mEq/L Citrate. 40 USP units/mL: Each 100 mL of the 20,000 USP units per 500 mL preparation contains: 4,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 50 USP units/mL: Each 100 mL of the 25,000 USP units per 500 mL preparation contains: 5,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 100 USP units/mL: Each 100 mL of the 25,000 USP units per 250 mL preparation contains: 10,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector."
},
{
"NDCCode": "0264-9577-10",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-9577-10) / 500 mL in 1 CONTAINER",
"NDC11Code": "00264-9577-10",
"ProductNDC": "0264-9577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium In Dextrose",
"NonProprietaryName": "Heparin Sodium And Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19920720",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019952",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "HEPARIN SODIUM; DEXTROSE MONOHYDRATE",
"StrengthNumber": "5000; 5",
"StrengthUnit": "[USP'U]/100mL; g/100mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19920720",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium in 5% Dextrose Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism, 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, 3 Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation), 4 Prevention of clotting in arterial and cardiac surgery, 5 Prophylaxis and treatment of peripheral arterial embolism, 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
"Description": "Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of alpha-L-iduronic acid 2-sulfate (1), 2-deoxy-2-sulfamino- alpha-D-glucose 6-sulfate (2), beta-D-glucuronic acid (3), 2-acetamido-2- deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. The pH range is 5.6 (4.5 – 7.0) and the osmolarity mOsmol/L (calc.) is 315. The concentration of electrolytes is 38 mEq/L Sodium, 30 mEq/L Phosphate, and 15 mEq/L Citrate. 40 USP units/mL: Each 100 mL of the 20,000 USP units per 500 mL preparation contains: 4,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 50 USP units/mL: Each 100 mL of the 25,000 USP units per 500 mL preparation contains: 5,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 100 USP units/mL: Each 100 mL of the 25,000 USP units per 250 mL preparation contains: 10,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector."
},
{
"NDCCode": "0264-9587-20",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-9587-20) / 250 mL in 1 CONTAINER",
"NDC11Code": "00264-9587-20",
"ProductNDC": "0264-9587",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium In Dextrose",
"NonProprietaryName": "Heparin Sodium And Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19920720",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019952",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "HEPARIN SODIUM; DEXTROSE MONOHYDRATE",
"StrengthNumber": "10000; 5",
"StrengthUnit": "[USP'U]/100mL; g/100mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19920720",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium in 5% Dextrose Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism, 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, 3 Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation), 4 Prevention of clotting in arterial and cardiac surgery, 5 Prophylaxis and treatment of peripheral arterial embolism, 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
"Description": "Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of alpha-L-iduronic acid 2-sulfate (1), 2-deoxy-2-sulfamino- alpha-D-glucose 6-sulfate (2), beta-D-glucuronic acid (3), 2-acetamido-2- deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. The pH range is 5.6 (4.5 – 7.0) and the osmolarity mOsmol/L (calc.) is 315. The concentration of electrolytes is 38 mEq/L Sodium, 30 mEq/L Phosphate, and 15 mEq/L Citrate. 40 USP units/mL: Each 100 mL of the 20,000 USP units per 500 mL preparation contains: 4,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 50 USP units/mL: Each 100 mL of the 25,000 USP units per 500 mL preparation contains: 5,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 100 USP units/mL: Each 100 mL of the 25,000 USP units per 250 mL preparation contains: 10,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector."
},
{
"NDCCode": "0363-0686-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (0363-0686-50) ",
"NDC11Code": "00363-0686-50",
"ProductNDC": "0363-0686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Low Dose Aspirin",
"NonProprietaryName": "Aspirin 81 Mg Delayed Release Tablets",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211008",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "WALGREENS",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211008",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief., 2 ask your doctor about other uses for enteric-coated 81 mg Aspirin ."
},
{
"NDCCode": "0703-0686-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-0686-01) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-0686-01",
"ProductNDC": "0703-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Treprostinil",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20190930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206648",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2022-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190930",
"SamplePackage": "N",
"IndicationAndUsage": "Treprostinil Injection is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Treprostinil Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Treprostinil Injection is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL, or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contains 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate, and Water for Injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-. 1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is."
},
{
"NDCCode": "10135-686-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-686-01) ",
"NDC11Code": "10135-0686-01",
"ProductNDC": "10135-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nadolol",
"NonProprietaryName": "Nadolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210955",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "NADOLOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Angina Pectoris. Nadolol tablets, USP is indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Nadolol tablets, USP. 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 one 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. Nadolol tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Nadolol tablets, USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1- (tert-butyl - amino) -3- [(5,6,7,8-tetrahydro-cis-6,7 -dihydroxy -1-naphthyl) oxy] -2-propanol. Structural formula. Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients:Microcrystalline Cellulose (Type 101), Com Starch, FD&C Blue#2, Indigo carmine Aluminum Lake, Copovidone, Citric Acid Monohydrate, Sodium Starch Glycolate, Magnesium Stearate and Purified Water."
},
{
"NDCCode": "10147-0686-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (10147-0686-1) ",
"NDC11Code": "10147-0686-01",
"ProductNDC": "10147-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000801",
"EndMarketingDate": "20260113",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021121",
"LabelerName": "Patriot Pharmaceuticals, LLC.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190218",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate HCl Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)] .",
"Description": "Methylphenidate HCl Extended-Release Tablets are a central nervous system (CNS) stimulant. Methylphenidate HCl Extended-Release Tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14H 19NO 2∙HCl. Its structural formula is:. Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl Extended-Release Tablets also contain the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin."
},
{
"NDCCode": "10967-686-17",
"PackageDescription": "50 mL in 1 TUBE (10967-686-17) ",
"NDC11Code": "10967-0686-17",
"ProductNDC": "10967-686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prevage Anti Aging Spf 30",
"NonProprietaryName": "Octisalate, Octinoxate, Oxybenzone, Avobenzone, Octocrylene,",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Revlon",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE",
"StrengthNumber": "7.5; 2.2; 5; 2; 5",
"StrengthUnit": "g/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200102",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun ."
},
{
"NDCCode": "12634-686-04",
"PackageDescription": "120 mL in 1 BOTTLE (12634-686-04)",
"NDC11Code": "12634-0686-04",
"ProductNDC": "12634-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone",
"NonProprietaryName": "Prednisolone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20030227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040401",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "PREDNISOLONE",
"StrengthNumber": "15",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Prednisolone Oral Solution is indicated in the following conditions:. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme. (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. In addition to the above indications Prednisolone Oral Solution is indicated for systemic dermatomyositis (polymyositis).",
"Description": "Prednisolone Oral Solution contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for Prednisolone is Pregna- 1,4-diene-3,20-dione,11,17,21- trihydroxy-,(11β)- (anhydrous). Prednisolone Oral Solution contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40."
},
{
"NDCCode": "13811-686-01",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (13811-686-01)",
"NDC11Code": "13811-0686-01",
"ProductNDC": "13811-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "13811-686-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (13811-686-10)",
"NDC11Code": "13811-0686-10",
"ProductNDC": "13811-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "13811-686-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (13811-686-30)",
"NDC11Code": "13811-0686-30",
"ProductNDC": "13811-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "13811-686-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13811-686-50)",
"NDC11Code": "13811-0686-50",
"ProductNDC": "13811-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "23155-686-31",
"PackageDescription": "5 mL in 1 VIAL, GLASS (23155-686-31) ",
"NDC11Code": "23155-0686-31",
"ProductNDC": "23155-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Octreotide Acetate",
"NonProprietaryName": "Octreotide Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203765",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "OCTREOTIDE ACETATE",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220525",
"SamplePackage": "N",
"Description": "Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl) propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1-mL single dose vials in 3 strengths, each mL containing 50 mcg, 100 mcg, or 500 mcg octreotide acetate, USP as the active ingredient and sterile 5-mL multi-dose vials in 2 strengths, containing 200 and 1,000 mcg/mL of octreotide acetate, USP as the active ingredient. Each mL of the single-dose vials also contains following inactive ingredients:glacial acetic acid, USP.......................................................................................................................................2 mgsodium acetate (trihydrate), USP........................................................................................................................2 mgsodium chloride, USP.........................................................................................................................................7 mgwater for injection........................................................................................................... quantity sufficient to 1 mL. Each mL of the multi-dose vials also contains following inactive ingredients:glacial acetic acid, USP......................................................................................................................................2 mgsodium acetate (trihydrate), USP........................................................................................................................2 mgsodium chloride, USP.........................................................................................................................................7 mgphenol, USP .......................................................................................................................................................5 mgwater for injection............................................................................................................ quantity sufficient to 1 mL. Glacial acetic acid, USP and sodium acetate (trihydrate), USP are added to provide a buffered solution, pH to 3.9 to 4.5.The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is."
},
{
"NDCCode": "31722-686-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (31722-686-01) ",
"NDC11Code": "31722-0686-01",
"ProductNDC": "31722-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216651",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220825",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets are indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and Ketorolac Tromethamine Tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablets therapy is not to exceed 5 days.",
"Description": "Ketorolac tromethamine tablets, USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the chemical structure is. Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP. Ketorolac tromethamine, USP may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 7.8 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.4. Its molecular formula is C 19H 24N 2O 6. Ketorolac tromethamine tablets, USP are available as round, white to off-white, film-coated, bevel edged biconvex tablets. Each tablet contains 10 mg ketorolac tromethamine, USP, the active ingredient, with added hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and lactose monohydrate. The white film-coating contains hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "33261-686-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-686-30)",
"NDC11Code": "33261-0686-30",
"ProductNDC": "33261-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lexapro",
"NonProprietaryName": "Escitalopram Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020814",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021323",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for: : 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .",
"Description": "Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Lexapro (escitalopram oxalate) is available as tablets or as an oral solution. Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor."
},
{
"NDCCode": "42291-686-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42291-686-01) ",
"NDC11Code": "42291-0686-01",
"ProductNDC": "42291-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Plus",
"NonProprietaryName": "Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120911",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "VITAMIN A ACETATE; CYANOCOBALAMIN; ASCORBIC ACID; CHOLECALCIFEROL; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ZINC OXIDE; CALCIUM CARBONATE; FERROUS FUMARATE; PYRIDOXINE HYDROCHLORIDE; CUPRIC OXIDE",
"StrengthNumber": "3080; 12; 120; 400; 1; 1.84; 3; 20; 22; 920; 25; 200; 27; 10; 2",
"StrengthUnit": "[iU]/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170719",
"SamplePackage": "N"
},
{
"NDCCode": "43269-686-17",
"PackageDescription": "517 mL in 1 BOTTLE, PUMP (43269-686-17)",
"NDC11Code": "43269-0686-17",
"ProductNDC": "43269-686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citrus Basil Antibacterial Creamy Hand Wash",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110525",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".2",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-08",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>51552-0686-2</NDCCode>
<PackageDescription>5 g in 1 CONTAINER (51552-0686-2)</PackageDescription>
<NDC11Code>51552-0686-02</NDC11Code>
<ProductNDC>51552-0686</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Meperidine Hcl</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51552-0686-1</NDCCode>
<PackageDescription>1 g in 1 CONTAINER (51552-0686-1)</PackageDescription>
<NDC11Code>51552-0686-01</NDC11Code>
<ProductNDC>51552-0686</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Meperidine Hcl</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51552-0686-4</NDCCode>
<PackageDescription>25 g in 1 CONTAINER (51552-0686-4) </PackageDescription>
<NDC11Code>51552-0686-04</NDC11Code>
<ProductNDC>51552-0686</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Meperidine Hcl</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>29-FEB-12</StartMarketingDatePackage>
<EndMarketingDatePackage>31-MAY-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11822-0686-4</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (11822-0686-4) > 2 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-0686-04</NDC11Code>
<ProductNDC>11822-0686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laxative</ProprietaryName>
<ProprietaryNameSuffix>Dye Free</ProprietaryNameSuffix>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160331</StartMarketingDate>
<EndMarketingDate>20231211</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160331</StartMarketingDatePackage>
<EndMarketingDatePackage>20231211</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-0686-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0686-2) </PackageDescription>
<NDC11Code>37662-0686-02</NDC11Code>
<ProductNDC>37662-0686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eucalyptus Globulus</ProprietaryName>
<NonProprietaryName>Eucalyptus Globulus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220621</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>EUCALYPTUS GLOBULUS LEAF</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-0686-2</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (50090-0686-2)</PackageDescription>
<NDC11Code>50090-0686-02</NDC11Code>
<ProductNDC>50090-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077856</ApplicationNumber>
<LabelerName>A-S Medication Solutions LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>66412-0686-2</NDCCode>
<PackageDescription>500 g in 1 DRUM (66412-0686-2) </PackageDescription>
<NDC11Code>66412-0686-02</NDC11Code>
<ProductNDC>66412-0686</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>VAMSI LABS LIMITED.</LabelerName>
<SubstanceName>MOMETASONE FUROATE MONOHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-15</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-JUL-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68788-0686-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (68788-0686-2) </PackageDescription>
<NDC11Code>68788-0686-02</NDC11Code>
<ProductNDC>68788-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diethylpropion Hcl Controlled-release</ProprietaryName>
<NonProprietaryName>Diethylpropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140212</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012546</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DIETHYLPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0686-1</NDCCode>
<PackageDescription>2 TABLET in 1 BOTTLE (71335-0686-1) </PackageDescription>
<NDC11Code>71335-0686-01</NDC11Code>
<ProductNDC>71335-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208963</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71335-0686-2</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (71335-0686-2) </PackageDescription>
<NDC11Code>71335-0686-02</NDC11Code>
<ProductNDC>71335-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208963</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0078-0686-15</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0078-0686-15) </PackageDescription>
<NDC11Code>00078-0686-15</NDC11Code>
<ProductNDC>0078-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022291</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0078-0686-55</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (0078-0686-55) </PackageDescription>
<NDC11Code>00078-0686-55</NDC11Code>
<ProductNDC>0078-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022291</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0264-9567-10</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-9567-10) / 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-9567-10</NDC11Code>
<ProductNDC>0264-9567</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium In Dextrose</ProprietaryName>
<NonProprietaryName>Heparin Sodium And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19920720</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019952</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>4000; 5</StrengthNumber>
<StrengthUnit>[USP'U]/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium in 5% Dextrose Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism, 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, 3 Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation), 4 Prevention of clotting in arterial and cardiac surgery, 5 Prophylaxis and treatment of peripheral arterial embolism, 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
<Description>Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of alpha-L-iduronic acid 2-sulfate (1), 2-deoxy-2-sulfamino- alpha-D-glucose 6-sulfate (2), beta-D-glucuronic acid (3), 2-acetamido-2- deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. The pH range is 5.6 (4.5 – 7.0) and the osmolarity mOsmol/L (calc.) is 315. The concentration of electrolytes is 38 mEq/L Sodium, 30 mEq/L Phosphate, and 15 mEq/L Citrate. 40 USP units/mL: Each 100 mL of the 20,000 USP units per 500 mL preparation contains: 4,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 50 USP units/mL: Each 100 mL of the 25,000 USP units per 500 mL preparation contains: 5,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 100 USP units/mL: Each 100 mL of the 25,000 USP units per 250 mL preparation contains: 10,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector.</Description>
</NDC>
<NDC>
<NDCCode>0264-9577-10</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-9577-10) / 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-9577-10</NDC11Code>
<ProductNDC>0264-9577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium In Dextrose</ProprietaryName>
<NonProprietaryName>Heparin Sodium And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19920720</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019952</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5000; 5</StrengthNumber>
<StrengthUnit>[USP'U]/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium in 5% Dextrose Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism, 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, 3 Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation), 4 Prevention of clotting in arterial and cardiac surgery, 5 Prophylaxis and treatment of peripheral arterial embolism, 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
<Description>Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of alpha-L-iduronic acid 2-sulfate (1), 2-deoxy-2-sulfamino- alpha-D-glucose 6-sulfate (2), beta-D-glucuronic acid (3), 2-acetamido-2- deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. The pH range is 5.6 (4.5 – 7.0) and the osmolarity mOsmol/L (calc.) is 315. The concentration of electrolytes is 38 mEq/L Sodium, 30 mEq/L Phosphate, and 15 mEq/L Citrate. 40 USP units/mL: Each 100 mL of the 20,000 USP units per 500 mL preparation contains: 4,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 50 USP units/mL: Each 100 mL of the 25,000 USP units per 500 mL preparation contains: 5,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 100 USP units/mL: Each 100 mL of the 25,000 USP units per 250 mL preparation contains: 10,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector.</Description>
</NDC>
<NDC>
<NDCCode>0264-9587-20</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-9587-20) / 250 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-9587-20</NDC11Code>
<ProductNDC>0264-9587</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium In Dextrose</ProprietaryName>
<NonProprietaryName>Heparin Sodium And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19920720</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019952</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM; DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>10000; 5</StrengthNumber>
<StrengthUnit>[USP'U]/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium in 5% Dextrose Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism, 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, 3 Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation), 4 Prevention of clotting in arterial and cardiac surgery, 5 Prophylaxis and treatment of peripheral arterial embolism, 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
<Description>Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of alpha-L-iduronic acid 2-sulfate (1), 2-deoxy-2-sulfamino- alpha-D-glucose 6-sulfate (2), beta-D-glucuronic acid (3), 2-acetamido-2- deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits). Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. The pH range is 5.6 (4.5 – 7.0) and the osmolarity mOsmol/L (calc.) is 315. The concentration of electrolytes is 38 mEq/L Sodium, 30 mEq/L Phosphate, and 15 mEq/L Citrate. 40 USP units/mL: Each 100 mL of the 20,000 USP units per 500 mL preparation contains: 4,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 50 USP units/mL: Each 100 mL of the 25,000 USP units per 500 mL preparation contains: 5,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. 100 USP units/mL: Each 100 mL of the 25,000 USP units per 250 mL preparation contains: 10,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector.</Description>
</NDC>
<NDC>
<NDCCode>0363-0686-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0363-0686-50) </PackageDescription>
<NDC11Code>00363-0686-50</NDC11Code>
<ProductNDC>0363-0686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Low Dose Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin 81 Mg Delayed Release Tablets</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211008</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>WALGREENS</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief., 2 ask your doctor about other uses for enteric-coated 81 mg Aspirin .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0703-0686-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-0686-01) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-0686-01</NDC11Code>
<ProductNDC>0703-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Treprostinil</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206648</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treprostinil Injection is a prostacyclin mimetic indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Treprostinil Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Treprostinil Injection is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL, or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contains 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate, and Water for Injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-. 1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is.</Description>
</NDC>
<NDC>
<NDCCode>10135-686-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-686-01) </PackageDescription>
<NDC11Code>10135-0686-01</NDC11Code>
<ProductNDC>10135-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nadolol</ProprietaryName>
<NonProprietaryName>Nadolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210955</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>NADOLOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Angina Pectoris. Nadolol tablets, USP is indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Nadolol tablets, USP. 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 one 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. Nadolol tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Nadolol tablets, USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1- (tert-butyl - amino) -3- [(5,6,7,8-tetrahydro-cis-6,7 -dihydroxy -1-naphthyl) oxy] -2-propanol. Structural formula. Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients:Microcrystalline Cellulose (Type 101), Com Starch, FD&C Blue#2, Indigo carmine Aluminum Lake, Copovidone, Citric Acid Monohydrate, Sodium Starch Glycolate, Magnesium Stearate and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>10147-0686-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10147-0686-1) </PackageDescription>
<NDC11Code>10147-0686-01</NDC11Code>
<ProductNDC>10147-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000801</StartMarketingDate>
<EndMarketingDate>20260113</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021121</ApplicationNumber>
<LabelerName>Patriot Pharmaceuticals, LLC.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190218</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate HCl Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Methylphenidate HCl Extended-Release Tablets are a central nervous system (CNS) stimulant. Methylphenidate HCl Extended-Release Tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14H 19NO 2∙HCl. Its structural formula is:. Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl Extended-Release Tablets also contain the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>10967-686-17</NDCCode>
<PackageDescription>50 mL in 1 TUBE (10967-686-17) </PackageDescription>
<NDC11Code>10967-0686-17</NDC11Code>
<ProductNDC>10967-686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prevage Anti Aging Spf 30</ProprietaryName>
<NonProprietaryName>Octisalate, Octinoxate, Oxybenzone, Avobenzone, Octocrylene,</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Revlon</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE</SubstanceName>
<StrengthNumber>7.5; 2.2; 5; 2; 5</StrengthNumber>
<StrengthUnit>g/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12634-686-04</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (12634-686-04)</PackageDescription>
<NDC11Code>12634-0686-04</NDC11Code>
<ProductNDC>12634-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisolone</ProprietaryName>
<NonProprietaryName>Prednisolone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040401</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>PREDNISOLONE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prednisolone Oral Solution is indicated in the following conditions:. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme. (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. In addition to the above indications Prednisolone Oral Solution is indicated for systemic dermatomyositis (polymyositis).</IndicationAndUsage>
<Description>Prednisolone Oral Solution contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for Prednisolone is Pregna- 1,4-diene-3,20-dione,11,17,21- trihydroxy-,(11β)- (anhydrous). Prednisolone Oral Solution contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40.</Description>
</NDC>
<NDC>
<NDCCode>13811-686-01</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (13811-686-01)</PackageDescription>
<NDC11Code>13811-0686-01</NDC11Code>
<ProductNDC>13811-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13811-686-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (13811-686-10)</PackageDescription>
<NDC11Code>13811-0686-10</NDC11Code>
<ProductNDC>13811-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13811-686-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (13811-686-30)</PackageDescription>
<NDC11Code>13811-0686-30</NDC11Code>
<ProductNDC>13811-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13811-686-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13811-686-50)</PackageDescription>
<NDC11Code>13811-0686-50</NDC11Code>
<ProductNDC>13811-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>23155-686-31</NDCCode>
<PackageDescription>5 mL in 1 VIAL, GLASS (23155-686-31) </PackageDescription>
<NDC11Code>23155-0686-31</NDC11Code>
<ProductNDC>23155-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Octreotide Acetate</ProprietaryName>
<NonProprietaryName>Octreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203765</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl) propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1-mL single dose vials in 3 strengths, each mL containing 50 mcg, 100 mcg, or 500 mcg octreotide acetate, USP as the active ingredient and sterile 5-mL multi-dose vials in 2 strengths, containing 200 and 1,000 mcg/mL of octreotide acetate, USP as the active ingredient. Each mL of the single-dose vials also contains following inactive ingredients:glacial acetic acid, USP.......................................................................................................................................2 mgsodium acetate (trihydrate), USP........................................................................................................................2 mgsodium chloride, USP.........................................................................................................................................7 mgwater for injection........................................................................................................... quantity sufficient to 1 mL. Each mL of the multi-dose vials also contains following inactive ingredients:glacial acetic acid, USP......................................................................................................................................2 mgsodium acetate (trihydrate), USP........................................................................................................................2 mgsodium chloride, USP.........................................................................................................................................7 mgphenol, USP .......................................................................................................................................................5 mgwater for injection............................................................................................................ quantity sufficient to 1 mL. Glacial acetic acid, USP and sodium acetate (trihydrate), USP are added to provide a buffered solution, pH to 3.9 to 4.5.The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is.</Description>
</NDC>
<NDC>
<NDCCode>31722-686-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (31722-686-01) </PackageDescription>
<NDC11Code>31722-0686-01</NDC11Code>
<ProductNDC>31722-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216651</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets are indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and Ketorolac Tromethamine Tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablets therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac tromethamine tablets, USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the chemical structure is. Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP. Ketorolac tromethamine, USP may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 7.8 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.4. Its molecular formula is C 19H 24N 2O 6. Ketorolac tromethamine tablets, USP are available as round, white to off-white, film-coated, bevel edged biconvex tablets. Each tablet contains 10 mg ketorolac tromethamine, USP, the active ingredient, with added hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and lactose monohydrate. The white film-coating contains hypromellose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>33261-686-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-686-30)</PackageDescription>
<NDC11Code>33261-0686-30</NDC11Code>
<ProductNDC>33261-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lexapro</ProprietaryName>
<NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020814</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021323</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for: : 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .</IndicationAndUsage>
<Description>Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Lexapro (escitalopram oxalate) is available as tablets or as an oral solution. Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor.</Description>
</NDC>
<NDC>
<NDCCode>42291-686-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42291-686-01) </PackageDescription>
<NDC11Code>42291-0686-01</NDC11Code>
<ProductNDC>42291-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Plus</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120911</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>VITAMIN A ACETATE; CYANOCOBALAMIN; ASCORBIC ACID; CHOLECALCIFEROL; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ZINC OXIDE; CALCIUM CARBONATE; FERROUS FUMARATE; PYRIDOXINE HYDROCHLORIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>3080; 12; 120; 400; 1; 1.84; 3; 20; 22; 920; 25; 200; 27; 10; 2</StrengthNumber>
<StrengthUnit>[iU]/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43269-686-17</NDCCode>
<PackageDescription>517 mL in 1 BOTTLE, PUMP (43269-686-17)</PackageDescription>
<NDC11Code>43269-0686-17</NDC11Code>
<ProductNDC>43269-686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citrus Basil Antibacterial Creamy Hand Wash</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110525</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-08</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>