{
"NDC": [
{
"NDCCode": "62217-186-12",
"PackageDescription": "237 mL in 1 TUBE (62217-186-12) ",
"NDC11Code": "62217-0186-12",
"ProductNDC": "62217-186",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth Block Up",
"ProprietaryNameSuffix": "Broad Spectrum Sport Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110824",
"EndMarketingDate": "20250707",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "FRUIT OF THE EARTH, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "20; 90; 75; 50; 15; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110824",
"EndMarketingDatePackage": "20250707",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "55289-186-12",
"PackageDescription": "12 CAPSULE in 1 BOTTLE, PLASTIC (55289-186-12) ",
"NDC11Code": "55289-0186-12",
"ProductNDC": "55289-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin (macrocrystals)",
"NonProprietaryName": "Nitrofurantoin (macrocrystals)",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074967",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20061128",
"SamplePackage": "N"
},
{
"NDCCode": "66096-186-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-186-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0186-06",
"ProductNDC": "66096-186",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Immunological Acute Terrain",
"NonProprietaryName": "Aconitum Napellus, Aranea Diadema, Arnica Montana, Asclepias Vincetoxicum, Baptisia Tinctoria, Bryonia Alba, Echinacea Angustifolia, Equisetum Hyemale, Eupatorium Perforliatum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Juglans Regia, Phytolacca Decandra, Sanguinaria Canadensis, Sarsaparilla, Sulphur, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150423",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACONITUM NAPELLUS; ARANEUS DIADEMATUS; ARNICA MONTANA; CYNANCHUM VINCETOXICUM ROOT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; JUGLANS REGIA LEAF; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; SMILAX REGELII ROOT; SULFUR; ZINC",
"StrengthNumber": "7; 9; 6; 12; 8; 10; 6; 7; 10; 8; 12; 6; 10; 8; 9; 10; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "USES: Temporarily relieves weak immune system response in acute pathologies. Improves acute immune responsiveness.**."
},
{
"NDCCode": "68428-186-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-186-12) ",
"NDC11Code": "68428-0186-12",
"ProductNDC": "68428-186",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ailanthus",
"NonProprietaryName": "Ailanthus Altissima Flowering Twig",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110126",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "AILANTHUS ALTISSIMA FLOWERING TWIG",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110126",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. AILANTHUS Red eruptions."
},
{
"NDCCode": "69097-186-12",
"PackageDescription": "500 TABLET in 1 BOTTLE (69097-186-12) ",
"NDC11Code": "69097-0186-12",
"ProductNDC": "69097-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077904",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160322",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: : 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1), 2 Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. (1.1), 3 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2), 4 Reduce elevated serum TG levels in patients with hypertriglyceridemia.(1.2), 5 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 6 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).",
"Description": "Pravastatin sodium tablets, USP is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Calcium Stearate, Crospovidone, Ferric Oxide, Low Substituted Hydroxypropyl Cellulose and Mannitol."
},
{
"NDCCode": "70377-186-12",
"PackageDescription": "84 TABLET, FILM COATED in 1 BOTTLE (70377-186-12) ",
"NDC11Code": "70377-0186-12",
"ProductNDC": "70377-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220660",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260909",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag tablets are 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. Eltrombopag tablets 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. Eltrombopag tablets 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": "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. 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 Eltrombopag tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: Hypromellose, titanium dioxide, polyethylene glycol 400, polysorbate 80 (12.5-mg tablet and 25-mg tablet), Iron Oxide yellow (50-mg tablet), Iron oxide Red (50-mg tablet and 75-mg tablet), Iron oxide Black (75-mg tablet)."
},
{
"NDCCode": "62217-050-03",
"PackageDescription": "88 mL in 1 BOTTLE (62217-050-03) ",
"NDC11Code": "62217-0050-03",
"ProductNDC": "62217-050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Block Up Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130419",
"EndMarketingDate": "20241217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "20; 90; 75; 50; 15; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130419",
"EndMarketingDatePackage": "20241217",
"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 aging caused by the sun ."
},
{
"NDCCode": "62217-050-16",
"PackageDescription": "30 mL in 1 TUBE (62217-050-16) ",
"NDC11Code": "62217-0050-16",
"ProductNDC": "62217-050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Block Up Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130419",
"EndMarketingDate": "20241217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "20; 90; 75; 50; 15; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130419",
"EndMarketingDatePackage": "20241217",
"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 aging caused by the sun ."
},
{
"NDCCode": "62217-236-14",
"PackageDescription": "1 TUBE in 1 CARTON (62217-236-14) > 125 mL in 1 TUBE (62217-236-13) ",
"NDC11Code": "62217-0236-14",
"ProductNDC": "62217-236",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth, Inc.",
"ProprietaryNameSuffix": "Calming Cleanser",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "62217-237-30",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (62217-237-30) > 15 mL in 1 BOTTLE, PUMP (62217-237-29) ",
"NDC11Code": "62217-0237-30",
"ProductNDC": "62217-237",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth, Inc.",
"ProprietaryNameSuffix": "Rapid Rescue Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0264-9872-00",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-9872-00) / 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-9872-00",
"ProductNDC": "0264-9872",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium In Sodium Chloride",
"NonProprietaryName": "Heparin Sodium In Sodium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19920720",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019953",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "[USP'U]/100mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231215",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium in 0.9% Sodium Chloride Injection at the concentration of 2 USP units/mL is indicated as an anticoagulant to maintain catheter patency.",
"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 0.9% Sodium Chloride Injection is a sterile, single-dose, clear, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) in 0.9% Sodium Chloride Injection. 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. Each 100 mL contains 200 USP Units Heparin Sodium, 0.43 g Dibasic Sodium Phosphate7H2O USP and 0.037 g Citric Acid Anhydrous USP as a buffer system, 0.9 g Sodium Chloride USP, and Water for Injection USP qs. pH: 7.0 (6.8-7.2); Calculated Osmolarity: 360 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 186; Chloride 154; Phosphate (HPO) 32; Citrate 6. 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": "0409-2222-12",
"PackageDescription": "12 POUCH in 1 CASE (0409-2222-12) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-2222-01) ",
"NDC11Code": "00409-2222-12",
"ProductNDC": "0409-2222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018916",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "[USP'U]/100mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230227",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.",
"Description": "Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium chloride, 0.9 g; citric acid, monohydrate, 40 mg and dibasic sodium phosphate, heptahydrate, 434 mg added as buffers. Each liter contains the following electrolytes: Sodium 186.4 mEq; phosphate (as HPO4=) 32.4 mEq, citrate 5.7 mEq and chloride 154 mEq. Osmolar concentration, 378 mOsmol/liter (calc.); pH 7.0 (5.0 – 7.5). Heparin Sodium, USP is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Dibasic Sodium Phosphate, USP (heptahydrate), is chemically designated (Na2HPO4 ∙ 7H2O), colorless or white granular salt freely soluble in water. Citric Acid, USP, hydrous (monohydrate) is chemically designated C6H8O7 ∙ H2O, colorless, translucent crystals or white crystalline powder very soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from either polyvinylchloride or polyolefin plastic. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
},
{
"NDCCode": "0409-7620-59",
"PackageDescription": "12 POUCH in 1 CASE (0409-7620-59) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-7620-49) ",
"NDC11Code": "00409-7620-59",
"ProductNDC": "0409-7620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018916",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "[USP'U]/100mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050331",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.",
"Description": "Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium chloride, 0.9 g; citric acid, monohydrate, 40 mg and dibasic sodium phosphate, heptahydrate, 434 mg added as buffers. Each liter contains the following electrolytes: Sodium 186.4 mEq; phosphate (as HPO4=) 32.4 mEq, citrate 5.7 mEq and chloride 154 mEq. Osmolar concentration, 378 mOsmol/liter (calc.); pH 7.0 (5.0 – 7.5). Heparin Sodium, USP is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Dibasic Sodium Phosphate, USP (heptahydrate), is chemically designated (Na2HPO4 ∙ 7H2O), colorless or white granular salt freely soluble in water. Citric Acid, USP, hydrous (monohydrate) is chemically designated C6H8O7 ∙ H2O, colorless, translucent crystals or white crystalline powder very soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from either polyvinylchloride or polyolefin plastic. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
},
{
"NDCCode": "0469-0420-99",
"PackageDescription": "10 CARTON in 1 CARTON (0469-0420-99) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00469-0420-99",
"ProductNDC": "0469-0420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cresemba",
"NonProprietaryName": "Isavuconazonium Sulfate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207501",
"LabelerName": "Astellas Pharma US, Inc.",
"SubstanceName": "ISAVUCONAZONIUM SULFATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150306",
"SamplePackage": "N",
"IndicationAndUsage": "CRESEMBA® is an azole antifungal indicated for use in the treatment of: : 1 Invasive aspergillosis. (1.1), 2 Invasive mucormycosis. (1.2).",
"Description": "CRESEMBA contains isavuconazonium sulfate, which is the prodrug of isavuconazole, an azole antifungal drug. Isavuconazonium sulfate drug substance is an amorphous, white to yellowish-white powder. The chemical name of isavuconazonium sulfate is glycine, N-methyl-, [2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridinyl]methyl ester, sulfate (1:1). The empirical formula is C35H35F2N8O5S·HSO4, the molecular weight is 814.84 and the structural formula is. CRESEMBA Capsules. CRESEMBA (isavuconazonium sulfate) 74.5 mg capsules are available for oral administration. Each CRESEMBA capsule contains 74.5 mg isavuconazonium sulfate, equivalent to 40 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA (isavuconazonium sulfate) 186 mg capsules are available for oral administration. Each CRESEMBA capsule contains 186 mg isavuconazonium sulfate, equivalent to 100 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA for Injection. CRESEMBA (isavuconazonium sulfate) for injection is available for intravenous administration. CRESEMBA for injection is a white to yellow sterile, lyophilized powder containing 372 mg isavuconazonium sulfate, equivalent to 200 mg isavuconazole, per vial. Inactive ingredients included in each vial are 96 mg mannitol and sulfuric acid for pH adjustment."
},
{
"NDCCode": "0469-0520-14",
"PackageDescription": "4 CARTON in 1 CARTON (0469-0520-14) > 14 BLISTER PACK in 1 CARTON (0469-0520-02) > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00469-0520-14",
"ProductNDC": "0469-0520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cresemba",
"NonProprietaryName": "Isavuconazonium Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207500",
"LabelerName": "Astellas Pharma US, Inc.",
"SubstanceName": "ISAVUCONAZONIUM SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151104",
"SamplePackage": "N",
"IndicationAndUsage": "CRESEMBA® is an azole antifungal indicated for use in the treatment of: : 1 Invasive aspergillosis. (1.1), 2 Invasive mucormycosis. (1.2).",
"Description": "CRESEMBA contains isavuconazonium sulfate, which is the prodrug of isavuconazole, an azole antifungal drug. Isavuconazonium sulfate drug substance is an amorphous, white to yellowish-white powder. The chemical name of isavuconazonium sulfate is glycine, N-methyl-, [2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridinyl]methyl ester, sulfate (1:1). The empirical formula is C35H35F2N8O5S·HSO4, the molecular weight is 814.84 and the structural formula is. CRESEMBA Capsules. CRESEMBA (isavuconazonium sulfate) 74.5 mg capsules are available for oral administration. Each CRESEMBA capsule contains 74.5 mg isavuconazonium sulfate, equivalent to 40 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA (isavuconazonium sulfate) 186 mg capsules are available for oral administration. Each CRESEMBA capsule contains 186 mg isavuconazonium sulfate, equivalent to 100 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA for Injection. CRESEMBA (isavuconazonium sulfate) for injection is available for intravenous administration. CRESEMBA for injection is a white to yellow sterile, lyophilized powder containing 372 mg isavuconazonium sulfate, equivalent to 200 mg isavuconazole, per vial. Inactive ingredients included in each vial are 96 mg mannitol and sulfuric acid for pH adjustment."
},
{
"NDCCode": "10544-186-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (10544-186-30)",
"NDC11Code": "10544-0186-30",
"ProductNDC": "10544-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Postherpetic Neuralgia. Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.",
"Description": "Gabapentin Capsules are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25."
},
{
"NDCCode": "12579-186-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BLISTER PACK (12579-186-05) ",
"NDC11Code": "12579-0186-05",
"ProductNDC": "12579-186",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20120913",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "OPELLA HEALTHCARE INTERNATIONAL SAS",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-12-01",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "13-SEP-12"
},
{
"NDCCode": "12579-186-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BLISTER PACK (12579-186-14) ",
"NDC11Code": "12579-0186-14",
"ProductNDC": "12579-186",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20120913",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "OPELLA HEALTHCARE INTERNATIONAL SAS",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-12-01",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "13-SEP-12"
},
{
"NDCCode": "13668-186-74",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (13668-186-74) > 10 TABLET, FILM COATED in 1 BLISTER PACK (13668-186-71) ",
"NDC11Code": "13668-0186-74",
"ProductNDC": "13668-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil Citrate",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091448",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180611",
"SamplePackage": "N"
},
{
"NDCCode": "14141-186-01",
"PackageDescription": "9 g in 1 JAR (14141-186-01) ",
"NDC11Code": "14141-0186-01",
"ProductNDC": "14141-186",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clarite Makeup For A Cleaner Appearance Spf 30 290-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200324",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BEL STAR S A",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "7.5; 7.84",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200324",
"SamplePackage": "N"
},
{
"NDCCode": "16590-186-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (16590-186-15)",
"NDC11Code": "16590-0186-15",
"ProductNDC": "16590-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040526",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows. pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide."
},
{
"NDCCode": "16590-186-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16590-186-30)",
"NDC11Code": "16590-0186-30",
"ProductNDC": "16590-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040526",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows. pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide."
},
{
"NDCCode": "16590-186-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (16590-186-90)",
"NDC11Code": "16590-0186-90",
"ProductNDC": "16590-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040526",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows. pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide."
},
{
"NDCCode": "24236-186-17",
"PackageDescription": "4 TABLET in 1 VIAL (24236-186-17)",
"NDC11Code": "24236-0186-17",
"ProductNDC": "24236-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070033",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "27241-186-30",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-186-30) ",
"NDC11Code": "27241-0186-30",
"ProductNDC": "27241-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20210119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213271",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210119",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: artificial peppermint flavor, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, mannitol, colloidal silicon dioxide, pregelatinized starch and sucralose. Composition of peppermint flavor: Maize maltodextrin, modified corn starch and flavorings. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine, USP. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile."
},
{
"NDCCode": "31645-186-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (31645-186-02) > 11 g in 1 CONTAINER (31645-186-01)",
"NDC11Code": "31645-0186-02",
"ProductNDC": "31645-186",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "City Glow Daily Defense Bronzer",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Physicians Formula Inc",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "15",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "31722-186-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-186-01) ",
"NDC11Code": "31722-0186-01",
"ProductNDC": "31722-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214959",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "2.5; 2.5; 2.5; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210929",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: Sugar spheres, hydroxy propyl methyl cellulose, talc, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, hard gelatin capsules, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, iron oxide red. The 5 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin and sodium lauryl sulfate. The 10 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulfate and D&C Red 28. The 15 mg capsule shell contain Titanium dioxide, FD & C Blue 1, D & C Red 28, gelatin and sodium lauryl sulfate. The 20 mg capsule shell contain Titanium dioxide, FD & C Red 3, FD & C Yellow 6, FD & C Blue 1, gelatin, sodium lauryl sulfate and FD & C Red 40. The 25 mg capsule shell contain Titanium dioxide, FD & C Red 40, FD & C Yellow 6, gelatin, sodium lauryl sulfate. The 30 mg capsule shell contain Titanium dioxide, FD & C Yellow 6, D & C Yellow 10, sodium lauryl sulfate and gelatin. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide."
},
{
"NDCCode": "32909-186-01",
"PackageDescription": "1900 mL in 1 JUG (32909-186-01)",
"NDC11Code": "32909-0186-01",
"ProductNDC": "32909-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "E-z-paque",
"NonProprietaryName": "Barium Sulfate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19841101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "E-Z-EM Canada Inc",
"SubstanceName": "BARIUM SULFATE",
"StrengthNumber": ".6",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "33332-018-01",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (33332-018-01) > .5 mL in 1 SYRINGE, GLASS (33332-018-02) ",
"NDC11Code": "33332-0018-01",
"ProductNDC": "33332-018",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Afluria",
"NonProprietaryName": "Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated) And Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20110715",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125254",
"LabelerName": "Seqirus Pty Ltd",
"SubstanceName": "INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110715",
"SamplePackage": "N"
},
{
"NDCCode": "33332-118-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (33332-118-10) > 5 mL in 1 VIAL, MULTI-DOSE (33332-118-11) ",
"NDC11Code": "33332-0118-10",
"ProductNDC": "33332-118",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Afluria",
"NonProprietaryName": "Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated) And Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20110715",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125254",
"LabelerName": "Seqirus Pty Ltd",
"SubstanceName": "IINFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110715",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62217-186-12</NDCCode>
<PackageDescription>237 mL in 1 TUBE (62217-186-12) </PackageDescription>
<NDC11Code>62217-0186-12</NDC11Code>
<ProductNDC>62217-186</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth Block Up</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Sport Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110824</StartMarketingDate>
<EndMarketingDate>20250707</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>FRUIT OF THE EARTH, INC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>20; 90; 75; 50; 15; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110824</StartMarketingDatePackage>
<EndMarketingDatePackage>20250707</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55289-186-12</NDCCode>
<PackageDescription>12 CAPSULE in 1 BOTTLE, PLASTIC (55289-186-12) </PackageDescription>
<NDC11Code>55289-0186-12</NDC11Code>
<ProductNDC>55289-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin (macrocrystals)</ProprietaryName>
<NonProprietaryName>Nitrofurantoin (macrocrystals)</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074967</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-186-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-186-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0186-06</NDC11Code>
<ProductNDC>66096-186</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Immunological Acute Terrain</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Aranea Diadema, Arnica Montana, Asclepias Vincetoxicum, Baptisia Tinctoria, Bryonia Alba, Echinacea Angustifolia, Equisetum Hyemale, Eupatorium Perforliatum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Juglans Regia, Phytolacca Decandra, Sanguinaria Canadensis, Sarsaparilla, Sulphur, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150423</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARANEUS DIADEMATUS; ARNICA MONTANA; CYNANCHUM VINCETOXICUM ROOT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; JUGLANS REGIA LEAF; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; SMILAX REGELII ROOT; SULFUR; ZINC</SubstanceName>
<StrengthNumber>7; 9; 6; 12; 8; 10; 6; 7; 10; 8; 12; 6; 10; 8; 9; 10; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves weak immune system response in acute pathologies. Improves acute immune responsiveness.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-186-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-186-12) </PackageDescription>
<NDC11Code>68428-0186-12</NDC11Code>
<ProductNDC>68428-186</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ailanthus</ProprietaryName>
<NonProprietaryName>Ailanthus Altissima Flowering Twig</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110126</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>AILANTHUS ALTISSIMA FLOWERING TWIG</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. AILANTHUS Red eruptions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69097-186-12</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (69097-186-12) </PackageDescription>
<NDC11Code>69097-0186-12</NDC11Code>
<ProductNDC>69097-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077904</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: : 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1), 2 Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. (1.1), 3 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2), 4 Reduce elevated serum TG levels in patients with hypertriglyceridemia.(1.2), 5 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 6 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).</IndicationAndUsage>
<Description>Pravastatin sodium tablets, USP is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Calcium Stearate, Crospovidone, Ferric Oxide, Low Substituted Hydroxypropyl Cellulose and Mannitol.</Description>
</NDC>
<NDC>
<NDCCode>70377-186-12</NDCCode>
<PackageDescription>84 TABLET, FILM COATED in 1 BOTTLE (70377-186-12) </PackageDescription>
<NDC11Code>70377-0186-12</NDC11Code>
<ProductNDC>70377-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220660</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag tablets are 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. Eltrombopag tablets 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. Eltrombopag tablets 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>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. 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 Eltrombopag tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: Hypromellose, titanium dioxide, polyethylene glycol 400, polysorbate 80 (12.5-mg tablet and 25-mg tablet), Iron Oxide yellow (50-mg tablet), Iron oxide Red (50-mg tablet and 75-mg tablet), Iron oxide Black (75-mg tablet).</Description>
</NDC>
<NDC>
<NDCCode>62217-050-03</NDCCode>
<PackageDescription>88 mL in 1 BOTTLE (62217-050-03) </PackageDescription>
<NDC11Code>62217-0050-03</NDC11Code>
<ProductNDC>62217-050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Block Up Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130419</StartMarketingDate>
<EndMarketingDate>20241217</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>20; 90; 75; 50; 15; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130419</StartMarketingDatePackage>
<EndMarketingDatePackage>20241217</EndMarketingDatePackage>
<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 aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-050-16</NDCCode>
<PackageDescription>30 mL in 1 TUBE (62217-050-16) </PackageDescription>
<NDC11Code>62217-0050-16</NDC11Code>
<ProductNDC>62217-050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth</ProprietaryName>
<ProprietaryNameSuffix>Block Up Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130419</StartMarketingDate>
<EndMarketingDate>20241217</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>20; 90; 75; 50; 15; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130419</StartMarketingDatePackage>
<EndMarketingDatePackage>20241217</EndMarketingDatePackage>
<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 aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-236-14</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62217-236-14) > 125 mL in 1 TUBE (62217-236-13) </PackageDescription>
<NDC11Code>62217-0236-14</NDC11Code>
<ProductNDC>62217-236</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth, Inc.</ProprietaryName>
<ProprietaryNameSuffix>Calming Cleanser</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171218</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62217-237-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (62217-237-30) > 15 mL in 1 BOTTLE, PUMP (62217-237-29) </PackageDescription>
<NDC11Code>62217-0237-30</NDC11Code>
<ProductNDC>62217-237</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth, Inc.</ProprietaryName>
<ProprietaryNameSuffix>Rapid Rescue Treatment</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<LabelerName>Fruit of the Earth, Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0264-9872-00</NDCCode>
<PackageDescription>12 CONTAINER in 1 CASE (0264-9872-00) / 1000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-9872-00</NDC11Code>
<ProductNDC>0264-9872</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Heparin Sodium In Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19920720</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019953</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[USP'U]/100mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium in 0.9% Sodium Chloride Injection at the concentration of 2 USP units/mL is indicated as an anticoagulant to maintain catheter patency.</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 0.9% Sodium Chloride Injection is a sterile, single-dose, clear, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) in 0.9% Sodium Chloride Injection. 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. Each 100 mL contains 200 USP Units Heparin Sodium, 0.43 g Dibasic Sodium Phosphate7H2O USP and 0.037 g Citric Acid Anhydrous USP as a buffer system, 0.9 g Sodium Chloride USP, and Water for Injection USP qs. pH: 7.0 (6.8-7.2); Calculated Osmolarity: 360 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 186; Chloride 154; Phosphate (HPO) 32; Citrate 6. 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>0409-2222-12</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-2222-12) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-2222-01) </PackageDescription>
<NDC11Code>00409-2222-12</NDC11Code>
<ProductNDC>0409-2222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018916</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[USP'U]/100mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.</IndicationAndUsage>
<Description>Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium chloride, 0.9 g; citric acid, monohydrate, 40 mg and dibasic sodium phosphate, heptahydrate, 434 mg added as buffers. Each liter contains the following electrolytes: Sodium 186.4 mEq; phosphate (as HPO4=) 32.4 mEq, citrate 5.7 mEq and chloride 154 mEq. Osmolar concentration, 378 mOsmol/liter (calc.); pH 7.0 (5.0 – 7.5). Heparin Sodium, USP is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Dibasic Sodium Phosphate, USP (heptahydrate), is chemically designated (Na2HPO4 ∙ 7H2O), colorless or white granular salt freely soluble in water. Citric Acid, USP, hydrous (monohydrate) is chemically designated C6H8O7 ∙ H2O, colorless, translucent crystals or white crystalline powder very soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from either polyvinylchloride or polyolefin plastic. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0409-7620-59</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-7620-59) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-7620-49) </PackageDescription>
<NDC11Code>00409-7620-59</NDC11Code>
<ProductNDC>0409-7620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050331</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018916</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[USP'U]/100mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.</IndicationAndUsage>
<Description>Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium chloride, 0.9 g; citric acid, monohydrate, 40 mg and dibasic sodium phosphate, heptahydrate, 434 mg added as buffers. Each liter contains the following electrolytes: Sodium 186.4 mEq; phosphate (as HPO4=) 32.4 mEq, citrate 5.7 mEq and chloride 154 mEq. Osmolar concentration, 378 mOsmol/liter (calc.); pH 7.0 (5.0 – 7.5). Heparin Sodium, USP is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Dibasic Sodium Phosphate, USP (heptahydrate), is chemically designated (Na2HPO4 ∙ 7H2O), colorless or white granular salt freely soluble in water. Citric Acid, USP, hydrous (monohydrate) is chemically designated C6H8O7 ∙ H2O, colorless, translucent crystals or white crystalline powder very soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from either polyvinylchloride or polyolefin plastic. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0469-0420-99</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (0469-0420-99) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00469-0420-99</NDC11Code>
<ProductNDC>0469-0420</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cresemba</ProprietaryName>
<NonProprietaryName>Isavuconazonium Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207501</ApplicationNumber>
<LabelerName>Astellas Pharma US, Inc.</LabelerName>
<SubstanceName>ISAVUCONAZONIUM SULFATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CRESEMBA® is an azole antifungal indicated for use in the treatment of: : 1 Invasive aspergillosis. (1.1), 2 Invasive mucormycosis. (1.2).</IndicationAndUsage>
<Description>CRESEMBA contains isavuconazonium sulfate, which is the prodrug of isavuconazole, an azole antifungal drug. Isavuconazonium sulfate drug substance is an amorphous, white to yellowish-white powder. The chemical name of isavuconazonium sulfate is glycine, N-methyl-, [2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridinyl]methyl ester, sulfate (1:1). The empirical formula is C35H35F2N8O5S·HSO4, the molecular weight is 814.84 and the structural formula is. CRESEMBA Capsules. CRESEMBA (isavuconazonium sulfate) 74.5 mg capsules are available for oral administration. Each CRESEMBA capsule contains 74.5 mg isavuconazonium sulfate, equivalent to 40 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA (isavuconazonium sulfate) 186 mg capsules are available for oral administration. Each CRESEMBA capsule contains 186 mg isavuconazonium sulfate, equivalent to 100 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA for Injection. CRESEMBA (isavuconazonium sulfate) for injection is available for intravenous administration. CRESEMBA for injection is a white to yellow sterile, lyophilized powder containing 372 mg isavuconazonium sulfate, equivalent to 200 mg isavuconazole, per vial. Inactive ingredients included in each vial are 96 mg mannitol and sulfuric acid for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>0469-0520-14</NDCCode>
<PackageDescription>4 CARTON in 1 CARTON (0469-0520-14) > 14 BLISTER PACK in 1 CARTON (0469-0520-02) > 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00469-0520-14</NDC11Code>
<ProductNDC>0469-0520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cresemba</ProprietaryName>
<NonProprietaryName>Isavuconazonium Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207500</ApplicationNumber>
<LabelerName>Astellas Pharma US, Inc.</LabelerName>
<SubstanceName>ISAVUCONAZONIUM SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CRESEMBA® is an azole antifungal indicated for use in the treatment of: : 1 Invasive aspergillosis. (1.1), 2 Invasive mucormycosis. (1.2).</IndicationAndUsage>
<Description>CRESEMBA contains isavuconazonium sulfate, which is the prodrug of isavuconazole, an azole antifungal drug. Isavuconazonium sulfate drug substance is an amorphous, white to yellowish-white powder. The chemical name of isavuconazonium sulfate is glycine, N-methyl-, [2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridinyl]methyl ester, sulfate (1:1). The empirical formula is C35H35F2N8O5S·HSO4, the molecular weight is 814.84 and the structural formula is. CRESEMBA Capsules. CRESEMBA (isavuconazonium sulfate) 74.5 mg capsules are available for oral administration. Each CRESEMBA capsule contains 74.5 mg isavuconazonium sulfate, equivalent to 40 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA (isavuconazonium sulfate) 186 mg capsules are available for oral administration. Each CRESEMBA capsule contains 186 mg isavuconazonium sulfate, equivalent to 100 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA for Injection. CRESEMBA (isavuconazonium sulfate) for injection is available for intravenous administration. CRESEMBA for injection is a white to yellow sterile, lyophilized powder containing 372 mg isavuconazonium sulfate, equivalent to 200 mg isavuconazole, per vial. Inactive ingredients included in each vial are 96 mg mannitol and sulfuric acid for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>10544-186-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (10544-186-30)</PackageDescription>
<NDC11Code>10544-0186-30</NDC11Code>
<ProductNDC>10544-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078428</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Postherpetic Neuralgia. Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.</IndicationAndUsage>
<Description>Gabapentin Capsules are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25.</Description>
</NDC>
<NDC>
<NDCCode>12579-186-05</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BLISTER PACK (12579-186-05) </PackageDescription>
<NDC11Code>12579-0186-05</NDC11Code>
<ProductNDC>12579-186</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20120913</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>OPELLA HEALTHCARE INTERNATIONAL SAS</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-12-01</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-SEP-12</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>12579-186-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BLISTER PACK (12579-186-14) </PackageDescription>
<NDC11Code>12579-0186-14</NDC11Code>
<ProductNDC>12579-186</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20120913</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>OPELLA HEALTHCARE INTERNATIONAL SAS</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-12-01</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-SEP-12</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>13668-186-74</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (13668-186-74) > 10 TABLET, FILM COATED in 1 BLISTER PACK (13668-186-71) </PackageDescription>
<NDC11Code>13668-0186-74</NDC11Code>
<ProductNDC>13668-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil Citrate</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091448</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14141-186-01</NDCCode>
<PackageDescription>9 g in 1 JAR (14141-186-01) </PackageDescription>
<NDC11Code>14141-0186-01</NDC11Code>
<ProductNDC>14141-186</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clarite Makeup For A Cleaner Appearance Spf 30 290-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 7.84</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-186-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (16590-186-15)</PackageDescription>
<NDC11Code>16590-0186-15</NDC11Code>
<ProductNDC>16590-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040526</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</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>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows. pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-186-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16590-186-30)</PackageDescription>
<NDC11Code>16590-0186-30</NDC11Code>
<ProductNDC>16590-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040526</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</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>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows. pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-186-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (16590-186-90)</PackageDescription>
<NDC11Code>16590-0186-90</NDC11Code>
<ProductNDC>16590-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040526</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</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>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows. pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24236-186-17</NDCCode>
<PackageDescription>4 TABLET in 1 VIAL (24236-186-17)</PackageDescription>
<NDC11Code>24236-0186-17</NDC11Code>
<ProductNDC>24236-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070033</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>27241-186-30</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-186-30) </PackageDescription>
<NDC11Code>27241-0186-30</NDC11Code>
<ProductNDC>27241-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213271</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: artificial peppermint flavor, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, mannitol, colloidal silicon dioxide, pregelatinized starch and sucralose. Composition of peppermint flavor: Maize maltodextrin, modified corn starch and flavorings. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine, USP. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>31645-186-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (31645-186-02) > 11 g in 1 CONTAINER (31645-186-01)</PackageDescription>
<NDC11Code>31645-0186-02</NDC11Code>
<ProductNDC>31645-186</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>City Glow Daily Defense Bronzer</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Physicians Formula Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>31722-186-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-186-01) </PackageDescription>
<NDC11Code>31722-0186-01</NDC11Code>
<ProductNDC>31722-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214959</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: Sugar spheres, hydroxy propyl methyl cellulose, talc, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, hard gelatin capsules, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, iron oxide red. The 5 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin and sodium lauryl sulfate. The 10 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulfate and D&C Red 28. The 15 mg capsule shell contain Titanium dioxide, FD & C Blue 1, D & C Red 28, gelatin and sodium lauryl sulfate. The 20 mg capsule shell contain Titanium dioxide, FD & C Red 3, FD & C Yellow 6, FD & C Blue 1, gelatin, sodium lauryl sulfate and FD & C Red 40. The 25 mg capsule shell contain Titanium dioxide, FD & C Red 40, FD & C Yellow 6, gelatin, sodium lauryl sulfate. The 30 mg capsule shell contain Titanium dioxide, FD & C Yellow 6, D & C Yellow 10, sodium lauryl sulfate and gelatin. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>32909-186-01</NDCCode>
<PackageDescription>1900 mL in 1 JUG (32909-186-01)</PackageDescription>
<NDC11Code>32909-0186-01</NDC11Code>
<ProductNDC>32909-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>E-z-paque</ProprietaryName>
<NonProprietaryName>Barium Sulfate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19841101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>E-Z-EM Canada Inc</LabelerName>
<SubstanceName>BARIUM SULFATE</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>33332-018-01</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (33332-018-01) > .5 mL in 1 SYRINGE, GLASS (33332-018-02) </PackageDescription>
<NDC11Code>33332-0018-01</NDC11Code>
<ProductNDC>33332-018</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Afluria</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated) And Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20110715</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125254</ApplicationNumber>
<LabelerName>Seqirus Pty Ltd</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>33332-118-10</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (33332-118-10) > 5 mL in 1 VIAL, MULTI-DOSE (33332-118-11) </PackageDescription>
<NDC11Code>33332-0118-10</NDC11Code>
<ProductNDC>33332-118</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Afluria</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated) And Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20110715</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125254</ApplicationNumber>
<LabelerName>Seqirus Pty Ltd</LabelerName>
<SubstanceName>IINFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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