{
"NDC": [
{
"NDCCode": "69290-143-80",
"PackageDescription": "29 mL in 1 BOTTLE, DISPENSING (69290-143-80)",
"NDC11Code": "69290-0143-80",
"ProductNDC": "69290-143",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Love And Beauty Lemon Fresh Essence Antibacterial Scented Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141017",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Forever 21",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "17.98",
"StrengthUnit": "mL/29mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "69290-140-80",
"PackageDescription": "29 mL in 1 PACKAGE (69290-140-80)",
"NDC11Code": "69290-0140-80",
"ProductNDC": "69290-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Love And Beauty Coconut Vanilla Essence Antibacterial Scented Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141017",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Forever 21",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "17.98",
"StrengthUnit": "mL/29mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69290-141-80",
"PackageDescription": "29 mL in 1 BOTTLE, DISPENSING (69290-141-80)",
"NDC11Code": "69290-0141-80",
"ProductNDC": "69290-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Love And Beauty Floral Rose Essence Antibacterial Scented Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141017",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Forever 21",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "17.98",
"StrengthUnit": "mL/29mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "69290-142-80",
"PackageDescription": "29 mL in 1 BOTTLE, DISPENSING (69290-142-80)",
"NDC11Code": "69290-0142-80",
"ProductNDC": "69290-142",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Love And Beauty Grapefruit Citrus Essence Antibacterial Scented Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141017",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Forever 21",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "17.98",
"StrengthUnit": "mL/29mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "69290-144-80",
"PackageDescription": "29 mL in 1 BOTTLE, DISPENSING (69290-144-80)",
"NDC11Code": "69290-0144-80",
"ProductNDC": "69290-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Love And Beauty Sweet Berry Essence Antibacterial Scented Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141017",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Forever 21",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "17.98",
"StrengthUnit": "mL/29mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "58103-143-80",
"PackageDescription": "800 kg in 1 BAG (58103-143-80) ",
"NDC11Code": "58103-0143-80",
"ProductNDC": "58103-143",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20231102",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI Pharma, Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "90",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2023-11-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "02-NOV-23"
},
{
"NDCCode": "67253-143-08",
"PackageDescription": "80 mL in 1 BOTTLE (67253-143-08)",
"NDC11Code": "67253-0143-08",
"ProductNDC": "67253-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19881125",
"EndMarketingDate": "20160630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062927",
"LabelerName": "DAVA Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68196-143-80",
"PackageDescription": "2.36 L in 1 BOTTLE (68196-143-80)",
"NDC11Code": "68196-0143-80",
"ProductNDC": "68196-143",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial",
"ProprietaryNameSuffix": "Light Moisturizers Refill",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110606",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".115",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "10544-143-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (10544-143-10)",
"NDC11Code": "10544-0143-10",
"ProductNDC": "10544-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200839",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets, USP and other antibacterial drugs, levofloxacin tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets, USP are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testingAppropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin tablets, USP [see Microbiology(12.4)] . Therapy with levofloxacin tablets, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets, USP. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
"Description": ". Levofloxacin USP is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin USP. The empirical formula is C 18H 20FN 3O 4½ H 2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3>Cu +2>Zn +2>Mg +2>Ca +2. Excipients and Description of Dosage FormsLevofloxacin Tablets, USP. Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80."
},
{
"NDCCode": "21695-143-72",
"PackageDescription": "120 TABLET in 1 BOTTLE (21695-143-72)",
"NDC11Code": "21695-0143-72",
"ProductNDC": "21695-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultracet",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021123",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "37.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ULTRACET® is indicated for the short-term (five days or less) management of acute pain.",
"Description": "ULTRACET® (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. ULTRACET® tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax."
},
{
"NDCCode": "24689-143-01",
"PackageDescription": "90 TABLET in 1 BOTTLE (24689-143-01) ",
"NDC11Code": "24689-0143-01",
"ProductNDC": "24689-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077491",
"LabelerName": "Apnar Pharma LP",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets is indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Pravastatin sodium tablets is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl- coenzyme A (HMG-CoA) reductase. 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. 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 for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.46, 18.97, 37.94 and 75.88 mg of pravastatin, respectively. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, dehydrated alcohol, dibasic sodium phosphate anhydrous, ferric oxide brown, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "43598-143-62",
"PackageDescription": "1 mL in 1 CARTON (43598-143-62) ",
"NDC11Code": "43598-0143-62",
"ProductNDC": "43598-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azacitidine",
"NonProprietaryName": "Azacitidine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220420",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207234",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "AZACITIDINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220420",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"Description": "Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine is a white to off-white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder."
},
{
"NDCCode": "49967-008-01",
"PackageDescription": "143 g in 1 BOTTLE, SPRAY (49967-008-01) ",
"NDC11Code": "49967-0008-01",
"ProductNDC": "49967-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "26.8; 96; 28.8; 53.8; 34.6",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140101",
"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": "51660-143-03",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (51660-143-03) ",
"NDC11Code": "51660-0143-03",
"ProductNDC": "51660-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077492",
"LabelerName": "Ohm Laboratories Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140707",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3) .",
"Description": "Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is:. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, soluble in methanol, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, ferric oxide black (in 160 mg and 320 mg strength), ferric oxide red (in 80 mg, 160 mg, and 320 mg strength), ferric oxide yellow (in 40 mg, 80 mg, and 320 mg strength), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, talc, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51660-143-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (51660-143-05) ",
"NDC11Code": "51660-0143-05",
"ProductNDC": "51660-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077492",
"LabelerName": "Ohm Laboratories Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140707",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3) .",
"Description": "Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is:. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, soluble in methanol, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, ferric oxide black (in 160 mg and 320 mg strength), ferric oxide red (in 80 mg, 160 mg, and 320 mg strength), ferric oxide yellow (in 40 mg, 80 mg, and 320 mg strength), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, talc, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51660-143-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (51660-143-90) ",
"NDC11Code": "51660-0143-90",
"ProductNDC": "51660-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077492",
"LabelerName": "Ohm Laboratories Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140707",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3) .",
"Description": "Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is:. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, soluble in methanol, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, ferric oxide black (in 160 mg and 320 mg strength), ferric oxide red (in 80 mg, 160 mg, and 320 mg strength), ferric oxide yellow (in 40 mg, 80 mg, and 320 mg strength), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, talc, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "58151-143-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93) ",
"NDC11Code": "58151-0143-93",
"ProductNDC": "58151-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inspra",
"NonProprietaryName": "Eplerenone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240917",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021437",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "EPLERENONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240917",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "INSPRA is an aldosterone antagonist indicated for: 1 Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. (1.1), 2 The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.2).",
"Description": "INSPRA contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, γ-lactone, methyl ester, (7α,11α,17α)-. Its empirical formula is C24H30O6 and it has a molecular weight of 414.50. The structural formula of eplerenone is represented below. Eplerenone is an odorless, white to off-white crystalline powder. It is very slightly soluble in water, with its solubility essentially pH-independent. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0. INSPRA tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "62225-300-00",
"PackageDescription": "1 VIAL in 1 CARTON (62225-300-00) / 2 mL in 1 VIAL",
"NDC11Code": "62225-0300-00",
"ProductNDC": "62225-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yartemlea",
"NonProprietaryName": "Narsoplimab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260120",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761152",
"LabelerName": "Omeros Corporation",
"SubstanceName": "NARSOPLIMAB",
"StrengthNumber": "370",
"StrengthUnit": "mg/2mL",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260120",
"SamplePackage": "N",
"IndicationAndUsage": "YARTEMLEA is indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).",
"Description": "Narsoplimab-wuug, a mannan-binding lectin-associated serine protease 2 (MASP-2) inhibitor, is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody produced in Chinese Hamster Ovary cells. The approximate molecular weight is 143 kDa. YARTEMLEA (narsoplimab-wuug) injection is a sterile, preservative-free, clear to slightly opalescent, slightly yellow to yellow-brown solution for intravenous infusion. Each 2-mL single-dose glass vial contains 370 mg of narsoplimab-wuug, arginine hydrochloride (84.3 mg), citric acid monohydrate (1.42 mg), polysorbate 80 (0.2 mg), sodium citrate (8.6 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid were added to adjust the pH to 5.8."
},
{
"NDCCode": "65862-143-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (65862-143-01) ",
"NDC11Code": "65862-0143-01",
"ProductNDC": "65862-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2."
},
{
"NDCCode": "65862-143-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65862-143-05) ",
"NDC11Code": "65862-0143-05",
"ProductNDC": "65862-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2."
},
{
"NDCCode": "65862-143-99",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-143-99) ",
"NDC11Code": "65862-0143-99",
"ProductNDC": "65862-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2."
},
{
"NDCCode": "68982-143-01",
"PackageDescription": "1 KIT in 1 CARTON (68982-143-01) * 2.5 mL in 1 VIAL (68982-144-01) * 2.5 mL in 1 VIAL (68982-901-01) ",
"NDC11Code": "68982-0143-01",
"ProductNDC": "68982-143",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Nuwiq",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125555",
"LabelerName": "Octapharma USA Inc",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "NUWIQ is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in pediatric and adult patients with Hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "NUWIQ, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal Factor VIII potencies of 250, 500, 1000, 1500, 2000, 2500, 3000 or 4000 IU. When reconstituted with 2.5 mL of solvent (Sterile Water for Injection), the respective nominal concentrations are 100, 200, 400, 600, 800, 1000, 1200 or 1600 IU/mL. The reconstituted product contains the following excipients per mL: 18 mg sodium chloride, 5.4 mg sucrose, 5.4 mg L-arginine hydrochloride, 0.3 mg calcium chloride dihydrate, 1.2 mg poloxamer 188, and 1.2 mg sodium citrate dihydrate. The concentration of each of the excipients is the same for all potencies. NUWIQ contains no preservatives. Each vial of NUWIQ is labeled with the actual Factor VIII potency expressed in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for Factor VIII concentrates. One IU, as defined by the WHO standard for human Factor VIII concentrates, is approximately equal to the level of Factor VIII activity in 1 mL of fresh pooled, normal, human plasma. The mean specific activity of NUWIQ is 8124 IU/mg total protein. B-domain deleted recombinant coagulation Factor VIII (BDD-rFVIII) is the active ingredient in NUWIQ. BDD-rFVIII is a recombinant glycoprotein (a heterodimer) with an approximate molecular mass of 170 kDa, comprising the Factor VIII domains A1-A2 (so-called heavy chain of ~90 kDa) and A3-C1-C2 (so-called light chain of ~80 kDa), whereas the B-domain, present in the full-length plasma-derived Factor VIII, has been deleted. The purified protein consists of 1440 amino acids. The amino acid sequence is comparable to the B-domain deleted form of human plasma Factor VIII (90 + 80 kDa). BDD-rFVIII is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells with no animal or human derived materials added during the manufacturing process or to the final product. As NUWIQ is produced using a human cell-line, it contains post-translational modifications comparable to human plasma-derived Factor VIII and is devoid of Neu5Gc or α-1,3-Gal epitopes that may be present in products produced in animal cells. Furthermore, BDD-rFVIII is fully sulfated at Tyr1680. The active substance is concentrated and purified by a series of chromatography steps, which also includes two dedicated viral clearance steps: solvent/detergent (S/D) treatment for virus inactivation and 20 nm nanofiltration for removal of viruses."
},
{
"NDCCode": "71205-143-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-30) ",
"NDC11Code": "71205-0143-30",
"ProductNDC": "71205-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078279",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 5.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 6.Risk reduction of NSAID-associated gastric ulcer (1.2), 3 7. H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3), 4 8. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .",
"Description": "The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "71205-143-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-60) ",
"NDC11Code": "71205-0143-60",
"ProductNDC": "71205-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078279",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 5.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 6.Risk reduction of NSAID-associated gastric ulcer (1.2), 3 7. H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3), 4 8. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .",
"Description": "The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "71205-143-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-90) ",
"NDC11Code": "71205-0143-90",
"ProductNDC": "71205-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078279",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181211",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 5.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 6.Risk reduction of NSAID-associated gastric ulcer (1.2), 3 7. H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3), 4 8. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .",
"Description": "The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "72511-143-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (72511-143-01) / 1 mL in 1 SYRINGE",
"NDC11Code": "72511-0143-01",
"ProductNDC": "72511-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Repatha",
"NonProprietaryName": "Evolocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260713",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125522",
"LabelerName": "Amgen USA Inc.",
"SubstanceName": "EVOLOCUMAB",
"StrengthNumber": "140",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "REPATHA is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia.adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL prefilled single-dose pen, prefilled single-dose SureClick® autoinjector and prefilled single-dose syringe contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0."
},
{
"NDCCode": "72511-143-02",
"PackageDescription": "1 SYRINGE in 1 CARTON (72511-143-02) / 1 mL in 1 SYRINGE",
"NDC11Code": "72511-0143-02",
"ProductNDC": "72511-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Repatha",
"NonProprietaryName": "Evolocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260713",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125522",
"LabelerName": "Amgen USA Inc.",
"SubstanceName": "EVOLOCUMAB",
"StrengthNumber": "140",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260713",
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"IndicationAndUsage": "REPATHA is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia.adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL prefilled single-dose pen, prefilled single-dose SureClick® autoinjector and prefilled single-dose syringe contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0."
},
{
"NDCCode": "72511-143-96",
"PackageDescription": "1 SYRINGE in 1 CARTON (72511-143-96) / 1 mL in 1 SYRINGE",
"NDC11Code": "72511-0143-96",
"ProductNDC": "72511-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Repatha",
"NonProprietaryName": "Evolocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260713",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125522",
"LabelerName": "Amgen USA Inc.",
"SubstanceName": "EVOLOCUMAB",
"StrengthNumber": "140",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
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"SamplePackage": "Y",
"IndicationAndUsage": "REPATHA is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia.adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL prefilled single-dose pen, prefilled single-dose SureClick® autoinjector and prefilled single-dose syringe contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0."
},
{
"NDCCode": "72789-143-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (72789-143-30) ",
"NDC11Code": "72789-0143-30",
"ProductNDC": "72789-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076341",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201022",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Pravastatin sodium is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. 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. 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 for oral use contains 10 mg, 20 mg, 40 mg and 80mg pravastatin sodium. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains Red Ferric Oxide, the 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide."
},
{
"NDCCode": "0143-9445-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0143-9445-01) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00143-9445-01",
"ProductNDC": "0143-9445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251211",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217415",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).",
"Description": "Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown."
}
]
}
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<ProductNDC>69290-143</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Love And Beauty Lemon Fresh Essence Antibacterial Scented Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<LabelerName>Forever 21</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>17.98</StrengthNumber>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>69290-140-80</NDCCode>
<PackageDescription>29 mL in 1 PACKAGE (69290-140-80)</PackageDescription>
<NDC11Code>69290-0140-80</NDC11Code>
<ProductNDC>69290-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Love And Beauty Coconut Vanilla Essence Antibacterial Scented Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141017</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Forever 21</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>17.98</StrengthNumber>
<StrengthUnit>mL/29mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>69290-141-80</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE, DISPENSING (69290-141-80)</PackageDescription>
<NDC11Code>69290-0141-80</NDC11Code>
<ProductNDC>69290-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Love And Beauty Floral Rose Essence Antibacterial Scented Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Forever 21</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>17.98</StrengthNumber>
<StrengthUnit>mL/29mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>69290-142-80</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE, DISPENSING (69290-142-80)</PackageDescription>
<NDC11Code>69290-0142-80</NDC11Code>
<ProductNDC>69290-142</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Love And Beauty Grapefruit Citrus Essence Antibacterial Scented Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141017</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Forever 21</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>17.98</StrengthNumber>
<StrengthUnit>mL/29mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>69290-144-80</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE, DISPENSING (69290-144-80)</PackageDescription>
<NDC11Code>69290-0144-80</NDC11Code>
<ProductNDC>69290-144</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Love And Beauty Sweet Berry Essence Antibacterial Scented Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141017</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Forever 21</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>17.98</StrengthNumber>
<StrengthUnit>mL/29mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58103-143-80</NDCCode>
<PackageDescription>800 kg in 1 BAG (58103-143-80) </PackageDescription>
<NDC11Code>58103-0143-80</NDC11Code>
<ProductNDC>58103-143</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20231102</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI Pharma, Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-11-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-NOV-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67253-143-08</NDCCode>
<PackageDescription>80 mL in 1 BOTTLE (67253-143-08)</PackageDescription>
<NDC11Code>67253-0143-08</NDC11Code>
<ProductNDC>67253-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881125</StartMarketingDate>
<EndMarketingDate>20160630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062927</ApplicationNumber>
<LabelerName>DAVA Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>68196-143-80</NDCCode>
<PackageDescription>2.36 L in 1 BOTTLE (68196-143-80)</PackageDescription>
<NDC11Code>68196-0143-80</NDC11Code>
<ProductNDC>68196-143</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial</ProprietaryName>
<ProprietaryNameSuffix>Light Moisturizers Refill</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110606</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.115</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
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<NDC>
<NDCCode>10544-143-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (10544-143-10)</PackageDescription>
<NDC11Code>10544-0143-10</NDC11Code>
<ProductNDC>10544-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200839</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets, USP and other antibacterial drugs, levofloxacin tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets, USP are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testingAppropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin tablets, USP [see Microbiology(12.4)] . Therapy with levofloxacin tablets, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets, USP. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.</IndicationAndUsage>
<Description>. Levofloxacin USP is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin USP. The empirical formula is C 18H 20FN 3O 4½ H 2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3>Cu +2>Zn +2>Mg +2>Ca +2. Excipients and Description of Dosage FormsLevofloxacin Tablets, USP. Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>21695-143-72</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (21695-143-72)</PackageDescription>
<NDC11Code>21695-0143-72</NDC11Code>
<ProductNDC>21695-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultracet</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021123</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>37.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ULTRACET® is indicated for the short-term (five days or less) management of acute pain.</IndicationAndUsage>
<Description>ULTRACET® (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. ULTRACET® tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>24689-143-01</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (24689-143-01) </PackageDescription>
<NDC11Code>24689-0143-01</NDC11Code>
<ProductNDC>24689-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077491</ApplicationNumber>
<LabelerName>Apnar Pharma LP</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>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets is indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium tablets is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl- coenzyme A (HMG-CoA) reductase. 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. 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 for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.46, 18.97, 37.94 and 75.88 mg of pravastatin, respectively. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, dehydrated alcohol, dibasic sodium phosphate anhydrous, ferric oxide brown, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>43598-143-62</NDCCode>
<PackageDescription>1 mL in 1 CARTON (43598-143-62) </PackageDescription>
<NDC11Code>43598-0143-62</NDC11Code>
<ProductNDC>43598-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azacitidine</ProprietaryName>
<NonProprietaryName>Azacitidine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220420</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207234</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>AZACITIDINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220420</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine is a white to off-white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.</Description>
</NDC>
<NDC>
<NDCCode>49967-008-01</NDCCode>
<PackageDescription>143 g in 1 BOTTLE, SPRAY (49967-008-01) </PackageDescription>
<NDC11Code>49967-0008-01</NDC11Code>
<ProductNDC>49967-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>26.8; 96; 28.8; 53.8; 34.6</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51660-143-03</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (51660-143-03) </PackageDescription>
<NDC11Code>51660-0143-03</NDC11Code>
<ProductNDC>51660-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077492</ApplicationNumber>
<LabelerName>Ohm Laboratories Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3) .</IndicationAndUsage>
<Description>Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is:. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, soluble in methanol, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, ferric oxide black (in 160 mg and 320 mg strength), ferric oxide red (in 80 mg, 160 mg, and 320 mg strength), ferric oxide yellow (in 40 mg, 80 mg, and 320 mg strength), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, talc, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51660-143-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (51660-143-05) </PackageDescription>
<NDC11Code>51660-0143-05</NDC11Code>
<ProductNDC>51660-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077492</ApplicationNumber>
<LabelerName>Ohm Laboratories Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3) .</IndicationAndUsage>
<Description>Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is:. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, soluble in methanol, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, ferric oxide black (in 160 mg and 320 mg strength), ferric oxide red (in 80 mg, 160 mg, and 320 mg strength), ferric oxide yellow (in 40 mg, 80 mg, and 320 mg strength), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, talc, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51660-143-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (51660-143-90) </PackageDescription>
<NDC11Code>51660-0143-90</NDC11Code>
<ProductNDC>51660-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077492</ApplicationNumber>
<LabelerName>Ohm Laboratories Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140707</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3) .</IndicationAndUsage>
<Description>Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is:. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, soluble in methanol, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, ferric oxide black (in 160 mg and 320 mg strength), ferric oxide red (in 80 mg, 160 mg, and 320 mg strength), ferric oxide yellow (in 40 mg, 80 mg, and 320 mg strength), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, talc, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>58151-143-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93) </PackageDescription>
<NDC11Code>58151-0143-93</NDC11Code>
<ProductNDC>58151-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inspra</ProprietaryName>
<NonProprietaryName>Eplerenone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240917</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021437</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>EPLERENONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240917</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INSPRA is an aldosterone antagonist indicated for: 1 Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. (1.1), 2 The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.2).</IndicationAndUsage>
<Description>INSPRA contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, γ-lactone, methyl ester, (7α,11α,17α)-. Its empirical formula is C24H30O6 and it has a molecular weight of 414.50. The structural formula of eplerenone is represented below. Eplerenone is an odorless, white to off-white crystalline powder. It is very slightly soluble in water, with its solubility essentially pH-independent. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0. INSPRA tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>62225-300-00</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (62225-300-00) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>62225-0300-00</NDC11Code>
<ProductNDC>62225-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yartemlea</ProprietaryName>
<NonProprietaryName>Narsoplimab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260120</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761152</ApplicationNumber>
<LabelerName>Omeros Corporation</LabelerName>
<SubstanceName>NARSOPLIMAB</SubstanceName>
<StrengthNumber>370</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YARTEMLEA is indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).</IndicationAndUsage>
<Description>Narsoplimab-wuug, a mannan-binding lectin-associated serine protease 2 (MASP-2) inhibitor, is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody produced in Chinese Hamster Ovary cells. The approximate molecular weight is 143 kDa. YARTEMLEA (narsoplimab-wuug) injection is a sterile, preservative-free, clear to slightly opalescent, slightly yellow to yellow-brown solution for intravenous infusion. Each 2-mL single-dose glass vial contains 370 mg of narsoplimab-wuug, arginine hydrochloride (84.3 mg), citric acid monohydrate (1.42 mg), polysorbate 80 (0.2 mg), sodium citrate (8.6 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid were added to adjust the pH to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>65862-143-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (65862-143-01) </PackageDescription>
<NDC11Code>65862-0143-01</NDC11Code>
<ProductNDC>65862-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>65862-143-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65862-143-05) </PackageDescription>
<NDC11Code>65862-0143-05</NDC11Code>
<ProductNDC>65862-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>65862-143-99</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (65862-143-99) </PackageDescription>
<NDC11Code>65862-0143-99</NDC11Code>
<ProductNDC>65862-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68982-143-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68982-143-01) * 2.5 mL in 1 VIAL (68982-144-01) * 2.5 mL in 1 VIAL (68982-901-01) </PackageDescription>
<NDC11Code>68982-0143-01</NDC11Code>
<ProductNDC>68982-143</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Nuwiq</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125555</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NUWIQ is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in pediatric and adult patients with Hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>NUWIQ, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal Factor VIII potencies of 250, 500, 1000, 1500, 2000, 2500, 3000 or 4000 IU. When reconstituted with 2.5 mL of solvent (Sterile Water for Injection), the respective nominal concentrations are 100, 200, 400, 600, 800, 1000, 1200 or 1600 IU/mL. The reconstituted product contains the following excipients per mL: 18 mg sodium chloride, 5.4 mg sucrose, 5.4 mg L-arginine hydrochloride, 0.3 mg calcium chloride dihydrate, 1.2 mg poloxamer 188, and 1.2 mg sodium citrate dihydrate. The concentration of each of the excipients is the same for all potencies. NUWIQ contains no preservatives. Each vial of NUWIQ is labeled with the actual Factor VIII potency expressed in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for Factor VIII concentrates. One IU, as defined by the WHO standard for human Factor VIII concentrates, is approximately equal to the level of Factor VIII activity in 1 mL of fresh pooled, normal, human plasma. The mean specific activity of NUWIQ is 8124 IU/mg total protein. B-domain deleted recombinant coagulation Factor VIII (BDD-rFVIII) is the active ingredient in NUWIQ. BDD-rFVIII is a recombinant glycoprotein (a heterodimer) with an approximate molecular mass of 170 kDa, comprising the Factor VIII domains A1-A2 (so-called heavy chain of ~90 kDa) and A3-C1-C2 (so-called light chain of ~80 kDa), whereas the B-domain, present in the full-length plasma-derived Factor VIII, has been deleted. The purified protein consists of 1440 amino acids. The amino acid sequence is comparable to the B-domain deleted form of human plasma Factor VIII (90 + 80 kDa). BDD-rFVIII is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells with no animal or human derived materials added during the manufacturing process or to the final product. As NUWIQ is produced using a human cell-line, it contains post-translational modifications comparable to human plasma-derived Factor VIII and is devoid of Neu5Gc or α-1,3-Gal epitopes that may be present in products produced in animal cells. Furthermore, BDD-rFVIII is fully sulfated at Tyr1680. The active substance is concentrated and purified by a series of chromatography steps, which also includes two dedicated viral clearance steps: solvent/detergent (S/D) treatment for virus inactivation and 20 nm nanofiltration for removal of viruses.</Description>
</NDC>
<NDC>
<NDCCode>71205-143-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-30) </PackageDescription>
<NDC11Code>71205-0143-30</NDC11Code>
<ProductNDC>71205-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078279</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 5.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 6.Risk reduction of NSAID-associated gastric ulcer (1.2), 3 7. H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3), 4 8. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71205-143-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-60) </PackageDescription>
<NDC11Code>71205-0143-60</NDC11Code>
<ProductNDC>71205-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078279</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 5.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 6.Risk reduction of NSAID-associated gastric ulcer (1.2), 3 7. H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3), 4 8. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71205-143-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-90) </PackageDescription>
<NDC11Code>71205-0143-90</NDC11Code>
<ProductNDC>71205-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078279</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 5.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 6.Risk reduction of NSAID-associated gastric ulcer (1.2), 3 7. H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3), 4 8. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72511-143-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (72511-143-01) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>72511-0143-01</NDC11Code>
<ProductNDC>72511-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Repatha</ProprietaryName>
<NonProprietaryName>Evolocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260713</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125522</ApplicationNumber>
<LabelerName>Amgen USA Inc.</LabelerName>
<SubstanceName>EVOLOCUMAB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REPATHA is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia.adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL prefilled single-dose pen, prefilled single-dose SureClick® autoinjector and prefilled single-dose syringe contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0.</Description>
</NDC>
<NDC>
<NDCCode>72511-143-02</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (72511-143-02) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>72511-0143-02</NDC11Code>
<ProductNDC>72511-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Repatha</ProprietaryName>
<NonProprietaryName>Evolocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260713</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125522</ApplicationNumber>
<LabelerName>Amgen USA Inc.</LabelerName>
<SubstanceName>EVOLOCUMAB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REPATHA is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia.adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL prefilled single-dose pen, prefilled single-dose SureClick® autoinjector and prefilled single-dose syringe contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0.</Description>
</NDC>
<NDC>
<NDCCode>72511-143-96</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (72511-143-96) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>72511-0143-96</NDC11Code>
<ProductNDC>72511-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Repatha</ProprietaryName>
<NonProprietaryName>Evolocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260713</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125522</ApplicationNumber>
<LabelerName>Amgen USA Inc.</LabelerName>
<SubstanceName>EVOLOCUMAB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260713</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>REPATHA is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia.adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL prefilled single-dose pen, prefilled single-dose SureClick® autoinjector and prefilled single-dose syringe contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0.</Description>
</NDC>
<NDC>
<NDCCode>72789-143-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (72789-143-30) </PackageDescription>
<NDC11Code>72789-0143-30</NDC11Code>
<ProductNDC>72789-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076341</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. 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. 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 for oral use contains 10 mg, 20 mg, 40 mg and 80mg pravastatin sodium. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains Red Ferric Oxide, the 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide.</Description>
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<NDC>
<NDCCode>0143-9445-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0143-9445-01) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00143-9445-01</NDC11Code>
<ProductNDC>0143-9445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251211</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217415</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
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<IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).</IndicationAndUsage>
<Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown.</Description>
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