{
"NDC": [
{
"NDCCode": "42192-133-16",
"PackageDescription": "473 mL in 1 BOTTLE (42192-133-16) ",
"NDC11Code": "42192-0133-16",
"ProductNDC": "42192-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110513",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "80; 40",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110513",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is. Each mL of Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension contains 80 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a formulation containing purified water, sodium cocoyl isethionate, disodium oleamido MIPA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glyceryl stearate, PEG-100 stearate, propylene glycol, methylparaben, propylparaben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl taurate, white petrolatum."
},
{
"NDCCode": "11673-133-16",
"PackageDescription": "1 BOTTLE in 1 CARTON (11673-133-16) / 59 mL in 1 BOTTLE",
"NDC11Code": "11673-0133-16",
"ProductNDC": "11673-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Acetaminophen",
"ProprietaryNameSuffix": "Infants",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20150422",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Target Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150422",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache."
},
{
"NDCCode": "68382-133-16",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-133-16) ",
"NDC11Code": "68382-0133-16",
"ProductNDC": "68382-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078239",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130107",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium extended-release tablets are indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium extended-release 250 and 500 mg tablets are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 or 500 mg of valproic acid. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lecithin, magnesium stearate, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), silicon dioxide, talc, titanium dioxide and xanthan gum. Each tablet is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. The Product meets USP Dissolution Test 8."
},
{
"NDCCode": "69685-133-16",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69685-133-16) / 473 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69685-0133-16",
"ProductNDC": "69685-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stellalife Vega Oral Care Spearmint",
"ProprietaryNameSuffix": "Advanced Healing Formula",
"NonProprietaryName": "Azadirachta Indica, Calendula, Echinacea Purpurea, Plantago Major",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20240208",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "StellaLife, Inc.",
"SubstanceName": "PLANTAGO MAJOR; AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWER; ECHINACEA PURPUREA",
"StrengthNumber": "3; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240208",
"SamplePackage": "N",
"IndicationAndUsage": "■ Antimicrobial. ■ Promotes oral health. ■ Hydrates oral cavity. ■ Supports healthy gums. ■ Freshens breath."
},
{
"NDCCode": "72570-133-16",
"PackageDescription": "454 g in 1 CONTAINER (72570-133-16) ",
"NDC11Code": "72570-0133-16",
"ProductNDC": "72570-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diaperene Maximum",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Delsam Pharma Llc",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2021-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N"
},
{
"NDCCode": "72578-133-16",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (72578-133-16) ",
"NDC11Code": "72578-0133-16",
"ProductNDC": "72578-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218991",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240830",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension,to lower blood pressure in adults and children 1 year 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, USP is a nonpeptide, orally active and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan, USP is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.52 g/mol, and its structural formula is. Valsartan, USP is a white or off-white powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan, USP is available as tablets 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, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide. Additionally, each 80 mg and 320 mg tablet contain iron oxide red and each 320 mg tablet contains ferrosoferric oxide."
},
{
"NDCCode": "42192-103-16",
"PackageDescription": "473 mL in 1 BOTTLE (42192-103-16) ",
"NDC11Code": "42192-0103-16",
"ProductNDC": "42192-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bp Cleansing Wash",
"NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080423",
"EndMarketingDate": "20230921",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 40",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080423",
"EndMarketingDatePackage": "20230921",
"SamplePackage": "N"
},
{
"NDCCode": "42192-105-16",
"PackageDescription": "12 CARTON in 1 PACKAGE (42192-105-16) > 1 TUBE in 1 CARTON > 42500 mg in 1 TUBE",
"NDC11Code": "42192-0105-16",
"ProductNDC": "42192-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bpo",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/100mg",
"Status": "Deprecated",
"LastUpdate": "2018-05-16",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Use treats acne and helps prevent new acne blemishes from forming."
},
{
"NDCCode": "42192-106-16",
"PackageDescription": "12 CARTON in 1 PACKAGE (42192-106-16) > 1 TUBE in 1 CARTON > 42500 mg in 1 TUBE",
"NDC11Code": "42192-0106-16",
"ProductNDC": "42192-106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bpo",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/100mg",
"Status": "Deprecated",
"LastUpdate": "2017-10-10"
},
{
"NDCCode": "42192-121-16",
"PackageDescription": "473.2 mL in 1 BOTTLE (42192-121-16) ",
"NDC11Code": "42192-0121-16",
"ProductNDC": "42192-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide - Sulfur Wash",
"NonProprietaryName": "Sodium Sulfacetamide, Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100916",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ACELLA PHARMACEUTICALS",
"SubstanceName": "SULFACETAMIDE; SULFUR",
"StrengthNumber": "90; 40",
"StrengthUnit": "mg/473.2mL; mg/473.2mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100916",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Each mL of Sodium Sulfacetamide 9% - Sulfur 4% Topical Suspension contains 90 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation containing aloe vera gel, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MIPA sulfosuccinate, glyceryl stearate and PEG 100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylene glycol, propyllparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, white pertrolatum, and xanthan gum."
},
{
"NDCCode": "42192-129-16",
"PackageDescription": "480 mL in 1 BOTTLE (42192-129-16) ",
"NDC11Code": "42192-0129-16",
"ProductNDC": "42192-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide",
"NonProprietaryName": "Sodium Sulfacetamide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110104",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110104",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.",
"Description": "Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Each mL of Sodium Sulfacetamide 10% Wash contains 100 mg of sodium sulfacetamide, USP in a formulation containing cocamidopropyl betaine, disodium EDTA, glyceryl stearate, methylparaben, PEG-6 caprylic/capric glyerides, PEG-60 almond triglyceride, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water, sodium lauryl sulfate and sodium thiosulfate. Sodium Sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "42192-144-16",
"PackageDescription": "1 BOTTLE in 1 CARTON (42192-144-16) / 454 g in 1 BOTTLE",
"NDC11Code": "42192-0144-16",
"ProductNDC": "42192-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide 9 Sulfur 4.5 Wash",
"NonProprietaryName": "Sulfacetamide Sodium And Sulfur",
"DosageFormName": "RINSE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "90; 45",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130320",
"SamplePackage": "N"
},
{
"NDCCode": "42192-514-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (42192-514-16)",
"NDC11Code": "42192-0514-16",
"ProductNDC": "42192-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Entre-s",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride And Chlorpheniramine Maleate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20091215",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Brookstone Pharmaceuticals, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "30; 30; 4",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-09"
},
{
"NDCCode": "42192-520-16",
"PackageDescription": "473 mL in 1 BOTTLE (42192-520-16) ",
"NDC11Code": "42192-0520-16",
"ProductNDC": "42192-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quadrapax",
"NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20110506",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
"StrengthNumber": "16.2; .1037; .0194; .0065",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110506",
"SamplePackage": "N"
},
{
"NDCCode": "42192-521-16",
"PackageDescription": "473 mL in 1 BOTTLE (42192-521-16)",
"NDC11Code": "42192-0521-16",
"ProductNDC": "42192-521",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pyrilamine-phenylephrine",
"NonProprietaryName": "Pyrilamine Maleate And Phenylephrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120822",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "PYRILAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "16; 5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "42192-523-16",
"PackageDescription": "473 mL in 1 BOTTLE (42192-523-16) ",
"NDC11Code": "42192-0523-16",
"ProductNDC": "42192-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Entre-cough",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, Guaifensin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130204",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "15; 175; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130204",
"SamplePackage": "N"
},
{
"NDCCode": "42192-607-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (42192-607-16) ",
"NDC11Code": "42192-0607-16",
"ProductNDC": "42192-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide",
"NonProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20160921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203375",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "2; 30; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160921",
"SamplePackage": "N",
"IndicationAndUsage": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
"Description": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a pink, sugar free syrup with a melon flavor. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP . . . . . . . . 2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP . . . 10 mg. Inactive Ingredients: citric acid anhydrous, FD&C Red No. 40, glycerin, melon flavoring, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. C 16H 19BrN 2C 4H 4O 4M.W. 435.31 Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O M.W. 370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration."
},
{
"NDCCode": "42192-608-16",
"PackageDescription": "470 mL in 1 BOTTLE (42192-608-16) ",
"NDC11Code": "42192-0608-16",
"ProductNDC": "42192-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076403",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121001",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Oral Solution is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin Oral Solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Gabapentin oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: anise flavor, artificial strawberry flavor, glycerin, hydrochloric acid, purified water, sodium hydroxide and xylitol."
},
{
"NDCCode": "42192-612-16",
"PackageDescription": "480 mL in 1 BOTTLE (42192-612-16) ",
"NDC11Code": "42192-0612-16",
"ProductNDC": "42192-612",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Chlorpheniramine Maleate",
"NonProprietaryName": "Hydrocodone Bitartrate And Chlorpheniramine Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20170614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206891",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "5; 4",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2021-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170614",
"SamplePackage": "N"
},
{
"NDCCode": "42192-619-16",
"PackageDescription": "473 mL in 1 BOTTLE (42192-619-16) ",
"NDC11Code": "42192-0619-16",
"ProductNDC": "42192-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20201112",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018965",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201112",
"EndMarketingDatePackage": "20280131",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Suspension is indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.",
"Description": "Naproxen Suspension (naproxen) is available as a light orange-colored opaque oral suspension containing 125 mg/5 mL of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. The molecular weight is 230.26 Its molecular formula is C 14H 14O 3, and it has the following chemical structure. Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in Naproxen Suspension include sucrose, magnesium aluminum silicate, sorbitol solution and sodium chloride (39 mg/5 mL, 1.5 mEq), methylparaben, fumaric acid, FD&C Yellow No. 6, imitation pineapple flavor, imitation orange flavor and purified water. The pH of the suspension ranges from 2.2 to 3.7."
},
{
"NDCCode": "42192-626-16",
"PackageDescription": "473 mL in 1 BOTTLE (42192-626-16) ",
"NDC11Code": "42192-0626-16",
"ProductNDC": "42192-626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyridostigmine Bromide",
"NonProprietaryName": "Pyridostigmine Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20231009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212405",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "PYRIDOSTIGMINE BROMIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231009",
"SamplePackage": "N",
"IndicationAndUsage": "Pyridostigmine bromide is useful in the treatment of myasthenia gravis.",
"Description": "Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Pyridostigmine bromide is available as an oral solution containing 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, FD&C Red No. 40, FD&C Blue No. 1, flavors and water."
},
{
"NDCCode": "42192-630-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (42192-630-16) ",
"NDC11Code": "42192-0630-16",
"ProductNDC": "42192-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide",
"NonProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203375",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "2; 30; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
"Description": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP . . . . . . . . 2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP . . . 10 mg. Inactive Ingredients: citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. C 16H 19BrN 2C 4H 4O 4 M.W. 435.31 Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O M.W. 370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration."
},
{
"NDCCode": "42192-104-06",
"PackageDescription": "1 TUBE in 1 CARTON (42192-104-06) / 170.1 g in 1 TUBE",
"NDC11Code": "42192-0104-06",
"ProductNDC": "42192-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"ProprietaryNameSuffix": "Wash",
"NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080604",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080604",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE:BP 10-1 Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "DESCRIPTION:Each gram of BP 10-1 Wash contains 100 mg of sodium sulfacetamide and 10 mg of sulfur in a wash containing butylated hydroxytoluene, cetyl alcohol, edetate disodium, glyceryl stearate and PEG-100 stearate, lactic acid, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide, sodium thiosulfate, stearyl alcohol, white petrolatum, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4- aminophenyl) sulfonyl]acetamide, monosodium salt monohydrate. The structural formula is."
},
{
"NDCCode": "42192-147-08",
"PackageDescription": "227 g in 1 BOTTLE (42192-147-08) ",
"NDC11Code": "42192-0147-08",
"ProductNDC": "42192-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide 10 Sulfur 2 Cleanser",
"NonProprietaryName": "Sulfacetamide Sodium And Sulfur",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140814",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140814",
"SamplePackage": "N",
"IndicationAndUsage": "SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram of SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of sulfur in a base containing: BHT, cetyl alcohol, disodium edta, glyceryl stearate, lactic acid, magnesium aluminum silicate, methylparaben, PEG-100 stearate, petrolatum, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:."
},
{
"NDCCode": "42192-623-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "42192-0623-03",
"ProductNDC": "42192-623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20230821",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208612",
"LabelerName": "Acella Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230821",
"SamplePackage": "N",
"IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets provide an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. : 1 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound., 2 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate."
},
{
"NDCCode": "42192-623-28",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "42192-0623-28",
"ProductNDC": "42192-623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20230821",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208612",
"LabelerName": "Acella Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230821",
"SamplePackage": "N",
"IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets provide an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. : 1 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound., 2 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate."
},
{
"NDCCode": "0006-5084-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) ",
"NDC11Code": "00006-5084-01",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "0006-5084-59",
"PackageDescription": "1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) ",
"NDC11Code": "00006-5084-59",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "Y",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "0173-0874-10",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0874-10",
"ProductNDC": "0173-0874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0874-14",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0874-14",
"ProductNDC": "0173-0874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arnuity Ellipta",
"NonProprietaryName": "Fluticasone Furoate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205625",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.",
"Description": "ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
}
]
}
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<NDCCode>42192-133-16</NDCCode>
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<ProductNDC>42192-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
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<LastUpdate>2026-07-16</LastUpdate>
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<IndicationAndUsage>Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is. Each mL of Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension contains 80 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a formulation containing purified water, sodium cocoyl isethionate, disodium oleamido MIPA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glyceryl stearate, PEG-100 stearate, propylene glycol, methylparaben, propylparaben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl taurate, white petrolatum.</Description>
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<NDCCode>11673-133-16</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-133-16) / 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0133-16</NDC11Code>
<ProductNDC>11673-133</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Acetaminophen</ProprietaryName>
<ProprietaryNameSuffix>Infants</ProprietaryNameSuffix>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
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<NDC>
<NDCCode>68382-133-16</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-133-16) </PackageDescription>
<NDC11Code>68382-0133-16</NDC11Code>
<ProductNDC>68382-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078239</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium extended-release tablets are indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium extended-release 250 and 500 mg tablets are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 or 500 mg of valproic acid. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lecithin, magnesium stearate, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), silicon dioxide, talc, titanium dioxide and xanthan gum. Each tablet is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. The Product meets USP Dissolution Test 8.</Description>
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<NDC>
<NDCCode>69685-133-16</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69685-133-16) / 473 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69685-0133-16</NDC11Code>
<ProductNDC>69685-133</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stellalife Vega Oral Care Spearmint</ProprietaryName>
<ProprietaryNameSuffix>Advanced Healing Formula</ProprietaryNameSuffix>
<NonProprietaryName>Azadirachta Indica, Calendula, Echinacea Purpurea, Plantago Major</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240208</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>StellaLife, Inc.</LabelerName>
<SubstanceName>PLANTAGO MAJOR; AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWER; ECHINACEA PURPUREA</SubstanceName>
<StrengthNumber>3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Antimicrobial. ■ Promotes oral health. ■ Hydrates oral cavity. ■ Supports healthy gums. ■ Freshens breath.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72570-133-16</NDCCode>
<PackageDescription>454 g in 1 CONTAINER (72570-133-16) </PackageDescription>
<NDC11Code>72570-0133-16</NDC11Code>
<ProductNDC>72570-133</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diaperene Maximum</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Delsam Pharma Llc</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>72578-133-16</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (72578-133-16) </PackageDescription>
<NDC11Code>72578-0133-16</NDC11Code>
<ProductNDC>72578-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218991</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240830</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 1 year 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, USP is a nonpeptide, orally active and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan, USP is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.52 g/mol, and its structural formula is. Valsartan, USP is a white or off-white powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan, USP is available as tablets 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, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide. Additionally, each 80 mg and 320 mg tablet contain iron oxide red and each 320 mg tablet contains ferrosoferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>42192-103-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (42192-103-16) </PackageDescription>
<NDC11Code>42192-0103-16</NDC11Code>
<ProductNDC>42192-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bp Cleansing Wash</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080423</StartMarketingDate>
<EndMarketingDate>20230921</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080423</StartMarketingDatePackage>
<EndMarketingDatePackage>20230921</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-105-16</NDCCode>
<PackageDescription>12 CARTON in 1 PACKAGE (42192-105-16) > 1 TUBE in 1 CARTON > 42500 mg in 1 TUBE</PackageDescription>
<NDC11Code>42192-0105-16</NDC11Code>
<ProductNDC>42192-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bpo</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/100mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-05-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Use treats acne and helps prevent new acne blemishes from forming.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42192-106-16</NDCCode>
<PackageDescription>12 CARTON in 1 PACKAGE (42192-106-16) > 1 TUBE in 1 CARTON > 42500 mg in 1 TUBE</PackageDescription>
<NDC11Code>42192-0106-16</NDC11Code>
<ProductNDC>42192-106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bpo</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/100mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>42192-121-16</NDCCode>
<PackageDescription>473.2 mL in 1 BOTTLE (42192-121-16) </PackageDescription>
<NDC11Code>42192-0121-16</NDC11Code>
<ProductNDC>42192-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide - Sulfur Wash</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100916</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ACELLA PHARMACEUTICALS</LabelerName>
<SubstanceName>SULFACETAMIDE; SULFUR</SubstanceName>
<StrengthNumber>90; 40</StrengthNumber>
<StrengthUnit>mg/473.2mL; mg/473.2mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Each mL of Sodium Sulfacetamide 9% - Sulfur 4% Topical Suspension contains 90 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation containing aloe vera gel, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MIPA sulfosuccinate, glyceryl stearate and PEG 100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylene glycol, propyllparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, white pertrolatum, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>42192-129-16</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (42192-129-16) </PackageDescription>
<NDC11Code>42192-0129-16</NDC11Code>
<ProductNDC>42192-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.</IndicationAndUsage>
<Description>Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Each mL of Sodium Sulfacetamide 10% Wash contains 100 mg of sodium sulfacetamide, USP in a formulation containing cocamidopropyl betaine, disodium EDTA, glyceryl stearate, methylparaben, PEG-6 caprylic/capric glyerides, PEG-60 almond triglyceride, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water, sodium lauryl sulfate and sodium thiosulfate. Sodium Sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>42192-144-16</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42192-144-16) / 454 g in 1 BOTTLE</PackageDescription>
<NDC11Code>42192-0144-16</NDC11Code>
<ProductNDC>42192-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 9 Sulfur 4.5 Wash</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium And Sulfur</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>90; 45</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-514-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (42192-514-16)</PackageDescription>
<NDC11Code>42192-0514-16</NDC11Code>
<ProductNDC>42192-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Entre-s</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride And Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Brookstone Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>30; 30; 4</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>42192-520-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (42192-520-16) </PackageDescription>
<NDC11Code>42192-0520-16</NDC11Code>
<ProductNDC>42192-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quadrapax</ProprietaryName>
<NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110506</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-521-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (42192-521-16)</PackageDescription>
<NDC11Code>42192-0521-16</NDC11Code>
<ProductNDC>42192-521</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pyrilamine-phenylephrine</ProprietaryName>
<NonProprietaryName>Pyrilamine Maleate And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120822</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PYRILAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>16; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>42192-523-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (42192-523-16) </PackageDescription>
<NDC11Code>42192-0523-16</NDC11Code>
<ProductNDC>42192-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Entre-cough</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, Guaifensin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 175; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-607-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (42192-607-16) </PackageDescription>
<NDC11Code>42192-0607-16</NDC11Code>
<ProductNDC>42192-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203375</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>2; 30; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
<Description>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a pink, sugar free syrup with a melon flavor. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP . . . . . . . . 2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP . . . 10 mg. Inactive Ingredients: citric acid anhydrous, FD&C Red No. 40, glycerin, melon flavoring, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. C 16H 19BrN 2C 4H 4O 4M.W. 435.31 Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O M.W. 370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>42192-608-16</NDCCode>
<PackageDescription>470 mL in 1 BOTTLE (42192-608-16) </PackageDescription>
<NDC11Code>42192-0608-16</NDC11Code>
<ProductNDC>42192-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076403</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Oral Solution is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin Oral Solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Gabapentin oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: anise flavor, artificial strawberry flavor, glycerin, hydrochloric acid, purified water, sodium hydroxide and xylitol.</Description>
</NDC>
<NDC>
<NDCCode>42192-612-16</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (42192-612-16) </PackageDescription>
<NDC11Code>42192-0612-16</NDC11Code>
<ProductNDC>42192-612</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Chlorpheniramine Maleate</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206891</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>5; 4</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-619-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (42192-619-16) </PackageDescription>
<NDC11Code>42192-0619-16</NDC11Code>
<ProductNDC>42192-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201112</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018965</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201112</StartMarketingDatePackage>
<EndMarketingDatePackage>20280131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Suspension is indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.</IndicationAndUsage>
<Description>Naproxen Suspension (naproxen) is available as a light orange-colored opaque oral suspension containing 125 mg/5 mL of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. The molecular weight is 230.26 Its molecular formula is C 14H 14O 3, and it has the following chemical structure. Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in Naproxen Suspension include sucrose, magnesium aluminum silicate, sorbitol solution and sodium chloride (39 mg/5 mL, 1.5 mEq), methylparaben, fumaric acid, FD&C Yellow No. 6, imitation pineapple flavor, imitation orange flavor and purified water. The pH of the suspension ranges from 2.2 to 3.7.</Description>
</NDC>
<NDC>
<NDCCode>42192-626-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (42192-626-16) </PackageDescription>
<NDC11Code>42192-0626-16</NDC11Code>
<ProductNDC>42192-626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyridostigmine Bromide</ProprietaryName>
<NonProprietaryName>Pyridostigmine Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212405</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PYRIDOSTIGMINE BROMIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pyridostigmine bromide is useful in the treatment of myasthenia gravis.</IndicationAndUsage>
<Description>Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Pyridostigmine bromide is available as an oral solution containing 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, FD&C Red No. 40, FD&C Blue No. 1, flavors and water.</Description>
</NDC>
<NDC>
<NDCCode>42192-630-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (42192-630-16) </PackageDescription>
<NDC11Code>42192-0630-16</NDC11Code>
<ProductNDC>42192-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203375</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>2; 30; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
<Description>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP . . . . . . . . 2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP . . . 10 mg. Inactive Ingredients: citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. C 16H 19BrN 2C 4H 4O 4 M.W. 435.31 Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O M.W. 370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>42192-104-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42192-104-06) / 170.1 g in 1 TUBE</PackageDescription>
<NDC11Code>42192-0104-06</NDC11Code>
<ProductNDC>42192-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
<ProprietaryNameSuffix>Wash</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080604</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE:BP 10-1 Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>DESCRIPTION:Each gram of BP 10-1 Wash contains 100 mg of sodium sulfacetamide and 10 mg of sulfur in a wash containing butylated hydroxytoluene, cetyl alcohol, edetate disodium, glyceryl stearate and PEG-100 stearate, lactic acid, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide, sodium thiosulfate, stearyl alcohol, white petrolatum, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4- aminophenyl) sulfonyl]acetamide, monosodium salt monohydrate. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>42192-147-08</NDCCode>
<PackageDescription>227 g in 1 BOTTLE (42192-147-08) </PackageDescription>
<NDC11Code>42192-0147-08</NDC11Code>
<ProductNDC>42192-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 10 Sulfur 2 Cleanser</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium And Sulfur</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140814</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram of SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of sulfur in a base containing: BHT, cetyl alcohol, disodium edta, glyceryl stearate, lactic acid, magnesium aluminum silicate, methylparaben, PEG-100 stearate, petrolatum, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>42192-623-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42192-0623-03</NDC11Code>
<ProductNDC>42192-623</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230821</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208612</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets provide an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. : 1 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound., 2 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate.</Description>
</NDC>
<NDC>
<NDCCode>42192-623-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42192-0623-28</NDC11Code>
<ProductNDC>42192-623</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230821</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208612</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets provide an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. : 1 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound., 2 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate.</Description>
</NDC>
<NDC>
<NDCCode>0006-5084-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) </PackageDescription>
<NDC11Code>00006-5084-01</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>0006-5084-59</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) </PackageDescription>
<NDC11Code>00006-5084-59</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>0173-0874-10</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0874-10</NDC11Code>
<ProductNDC>0173-0874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0874-14</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0874-14</NDC11Code>
<ProductNDC>0173-0874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arnuity Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205625</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use. ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
</NDCList>