{
"NDC": [
{
"NDCCode": "81968-045-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "81968-0045-31",
"ProductNDC": "81968-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "45; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240510",
"EndMarketingDatePackage": "20270328",
"SamplePackage": "Y",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "62331-045-31",
"PackageDescription": "50 kg in 1 DRUM (62331-045-31) ",
"NDC11Code": "62331-0045-31",
"ProductNDC": "62331-045",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Orlistat",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080423",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Divi's Laboratories Limited",
"SubstanceName": "ORLISTAT",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-08-05",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "23-APR-08"
},
{
"NDCCode": "81968-045-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "81968-0045-14",
"ProductNDC": "81968-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "45; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240918",
"SamplePackage": "Y",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "81968-045-30",
"PackageDescription": "30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) ",
"NDC11Code": "81968-0045-30",
"ProductNDC": "81968-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "45; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220818",
"SamplePackage": "N",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "81968-045-60",
"PackageDescription": "60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) ",
"NDC11Code": "81968-0045-60",
"ProductNDC": "81968-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "45; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240628",
"SamplePackage": "N",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"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": "11559-053-01",
"PackageDescription": "1 JAR in 1 CARTON (11559-053-01) / 50 mL in 1 JAR",
"NDC11Code": "11559-0053-01",
"ProductNDC": "11559-053",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Resilience Multi-effect Tri-peptide Face And Neck Creme Broad Spectrum Spf 15 Dry Skin",
"NonProprietaryName": "Avobenzone, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": ".03; .045; .027",
"StrengthUnit": "g/mL; g/mL; g/mL",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "16714-045-01",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-045-01) ",
"NDC11Code": "16714-0045-01",
"ProductNDC": "16714-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210610",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Northstar Rx LLC.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210610",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a SNRI. Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7."
},
{
"NDCCode": "33342-045-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-045-07) ",
"NDC11Code": "33342-0045-07",
"ProductNDC": "33342-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202230",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively."
},
{
"NDCCode": "33342-045-10",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (33342-045-10) ",
"NDC11Code": "33342-0045-10",
"ProductNDC": "33342-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202230",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively."
},
{
"NDCCode": "33342-045-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-045-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "33342-0045-12",
"ProductNDC": "33342-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202230",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively."
},
{
"NDCCode": "33342-045-44",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-045-44) ",
"NDC11Code": "33342-0045-44",
"ProductNDC": "33342-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202230",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160118",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively."
},
{
"NDCCode": "52343-045-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (52343-045-60) ",
"NDC11Code": "52343-0045-60",
"ProductNDC": "52343-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zidovudine",
"NonProprietaryName": "Zidovudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077267",
"LabelerName": "ACETRIS HEALTH, LLC",
"SubstanceName": "ZIDOVUDINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20050919",
"SamplePackage": "N"
},
{
"NDCCode": "62332-045-10",
"PackageDescription": "100 TABLET in 1 CARTON (62332-045-10) ",
"NDC11Code": "62332-0045-10",
"ProductNDC": "62332-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091367",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160520",
"SamplePackage": "N",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red."
},
{
"NDCCode": "62332-045-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (62332-045-30) ",
"NDC11Code": "62332-0045-30",
"ProductNDC": "62332-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091367",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160520",
"SamplePackage": "N",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red."
},
{
"NDCCode": "62332-045-71",
"PackageDescription": "500 TABLET in 1 BOTTLE (62332-045-71) ",
"NDC11Code": "62332-0045-71",
"ProductNDC": "62332-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091367",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160520",
"SamplePackage": "N",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red."
},
{
"NDCCode": "62332-045-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62332-045-90) ",
"NDC11Code": "62332-0045-90",
"ProductNDC": "62332-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091367",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160520",
"SamplePackage": "N",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red."
},
{
"NDCCode": "62332-045-91",
"PackageDescription": "1000 TABLET in 1 BOTTLE (62332-045-91) ",
"NDC11Code": "62332-0045-91",
"ProductNDC": "62332-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091367",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160520",
"SamplePackage": "N",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red."
},
{
"NDCCode": "65302-045-01",
"PackageDescription": "30 POUCH in 1 CARTON (65302-045-01) > 1 AMPULE in 1 POUCH > 3 mL in 1 AMPULE",
"NDC11Code": "65302-0045-01",
"ProductNDC": "65302-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20181226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077839",
"LabelerName": "The Ritedose Corporation",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181226",
"SamplePackage": "N"
},
{
"NDCCode": "70594-045-03",
"PackageDescription": "25 CARTON in 1 CARTON (70594-045-03) > 10 VIAL, GLASS in 1 CARTON (70594-045-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-045-01) ",
"NDC11Code": "70594-0045-03",
"ProductNDC": "70594-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204107",
"LabelerName": "Xellia Pharmaceuticals USA LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomem-branous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP is a lyophilized powder for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, mono-hydrochloride. The molecular formula is C66H75Cl2N9O24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula."
},
{
"NDCCode": "72028-045-03",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "72028-0045-03",
"ProductNDC": "72028-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wakix",
"NonProprietaryName": "Pitolisant Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190814",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211150",
"LabelerName": "Harmony Biosciences, LLC",
"SubstanceName": "PITOLISANT HYDROCHLORIDE",
"StrengthNumber": "4.45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inducers [MoA], Histamine H3 Receptor Antagonists [MoA], Histamine H3 Receptor Inverse Agonists [MoA], Histamine-3 Receptor Antagonist/Inverse Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190814",
"SamplePackage": "N",
"IndicationAndUsage": "WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.",
"Description": "WAKIX tablets contain pitolisant hydrochloride. Pitolisant is an antagonist/inverse agonist of the histamine-3 (H3) receptor. Pitolisant hydrochloride is a white or almost white crystalline powder with a molecular formula of C17H26ClNO·HCl and a molecular weight of 332.31. Pitolisant hydrochloride is soluble in water, ethanol, and methylene chloride and practically insoluble in cyclohexane. The chemical name of pitolisant hydrochloride is 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride and its structural formula is. The molecular formula of the pitolisant free base is C17H26ClNO and its molecular weight is 295.85. WAKIX tablets are for oral administration and each film-coated tablet contains 5 mg or 20 mg of pitolisant hydrochloride (equivalent to 4.45 mg or 17.8 mg of pitolisant free base, respectively) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "74530-045-01",
"PackageDescription": "29 mL in 1 BOTTLE (74530-045-01) ",
"NDC11Code": "74530-0045-01",
"ProductNDC": "74530-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Marvel Avengers Hand Sanitizer With Case",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200925",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Best Brand Consumers Products, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200925",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease the bacteria on the skin that could cause disease. Recommended for repeated use."
},
{
"NDCCode": "84951-012-01",
"PackageDescription": "1 BOTTLE in 1 BOX (84951-012-01) / 245 mL in 1 BOTTLE",
"NDC11Code": "84951-0012-01",
"ProductNDC": "84951-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anbiser B-ha Hyaluronic Acid Nourishing Body Wash",
"NonProprietaryName": "Glycerin",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241118",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Qingdao Huinorde Biotechnology Co., LTD",
"SubstanceName": ".ALPHA.-GLUCAN OLIGOSACCHARIDE; BUTYLENE GLYCOL; GLYCERIN; HEXYLENE GLYCOL; HYALURONATE SODIUM",
"StrengthNumber": ".03; .045; 10; .05; .006",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241118",
"SamplePackage": "N",
"IndicationAndUsage": "This body wash offers a luxurious fragrance while hydrating the skin. Formulated with small molecule hyaluronic acid and plant-based ingredients, it replenishes moisture and provides long-lasting hydration to the skin."
},
{
"NDCCode": "81968-020-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (81968-020-02) / 2 TABLET in 1 BOTTLE",
"NDC11Code": "81968-0020-02",
"ProductNDC": "81968-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbravo",
"NonProprietaryName": "Meloxicam, Rizatriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215431",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "MELOXICAM; RIZATRIPTAN BENZOATE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251121",
"SamplePackage": "Y"
},
{
"NDCCode": "81968-020-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (81968-020-03) / 3 TABLET in 1 BOTTLE",
"NDC11Code": "81968-0020-03",
"ProductNDC": "81968-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbravo",
"NonProprietaryName": "Meloxicam, Rizatriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215431",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "MELOXICAM; RIZATRIPTAN BENZOATE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250519",
"SamplePackage": "Y"
},
{
"NDCCode": "81968-020-09",
"PackageDescription": "9 TABLET in 1 BOTTLE (81968-020-09) ",
"NDC11Code": "81968-0020-09",
"ProductNDC": "81968-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbravo",
"NonProprietaryName": "Meloxicam, Rizatriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215431",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "MELOXICAM; RIZATRIPTAN BENZOATE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250519",
"SamplePackage": "N"
},
{
"NDCCode": "81968-030-22",
"PackageDescription": "1 BOTTLE in 1 CARTON (81968-030-22) / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "81968-0030-22",
"ProductNDC": "81968-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260508",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "30; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260508",
"SamplePackage": "Y",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "81968-345-01",
"PackageDescription": "1 KIT in 1 KIT (81968-345-01) * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "81968-0345-01",
"ProductNDC": "81968-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "81968-345-03",
"PackageDescription": "1 KIT in 1 KIT (81968-345-03) * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "81968-0345-03",
"ProductNDC": "81968-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "Y",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
}
]
}
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<NDCList>
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<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>Y</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
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<NDCCode>62331-045-31</NDCCode>
<PackageDescription>50 kg in 1 DRUM (62331-045-31) </PackageDescription>
<NDC11Code>62331-0045-31</NDC11Code>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Orlistat</NonProprietaryName>
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<StartMarketingDate>20080423</StartMarketingDate>
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<LabelerName>Divi's Laboratories Limited</LabelerName>
<SubstanceName>ORLISTAT</SubstanceName>
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<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
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<NDC>
<NDCCode>81968-045-14</NDCCode>
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<NDC11Code>81968-0045-14</NDC11Code>
<ProductNDC>81968-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240918</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>81968-045-30</NDCCode>
<PackageDescription>30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220818</StartMarketingDatePackage>
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<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>81968-045-60</NDCCode>
<PackageDescription>60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) </PackageDescription>
<NDC11Code>81968-0045-60</NDC11Code>
<ProductNDC>81968-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</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>
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<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>
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<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>11559-053-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11559-053-01) / 50 mL in 1 JAR</PackageDescription>
<NDC11Code>11559-0053-01</NDC11Code>
<ProductNDC>11559-053</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Resilience Multi-effect Tri-peptide Face And Neck Creme Broad Spectrum Spf 15 Dry Skin</ProprietaryName>
<NonProprietaryName>Avobenzone, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>.03; .045; .027</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-045-01</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-045-01) </PackageDescription>
<NDC11Code>16714-0045-01</NDC11Code>
<ProductNDC>16714-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210610</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Northstar Rx LLC.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210610</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a SNRI. Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7.</Description>
</NDC>
<NDC>
<NDCCode>33342-045-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-045-07) </PackageDescription>
<NDC11Code>33342-0045-07</NDC11Code>
<ProductNDC>33342-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202230</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>33342-045-10</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (33342-045-10) </PackageDescription>
<NDC11Code>33342-0045-10</NDC11Code>
<ProductNDC>33342-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202230</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>33342-045-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-045-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0045-12</NDC11Code>
<ProductNDC>33342-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202230</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>33342-045-44</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (33342-045-44) </PackageDescription>
<NDC11Code>33342-0045-44</NDC11Code>
<ProductNDC>33342-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202230</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>52343-045-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (52343-045-60) </PackageDescription>
<NDC11Code>52343-0045-60</NDC11Code>
<ProductNDC>52343-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zidovudine</ProprietaryName>
<NonProprietaryName>Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077267</ApplicationNumber>
<LabelerName>ACETRIS HEALTH, LLC</LabelerName>
<SubstanceName>ZIDOVUDINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62332-045-10</NDCCode>
<PackageDescription>100 TABLET in 1 CARTON (62332-045-10) </PackageDescription>
<NDC11Code>62332-0045-10</NDC11Code>
<ProductNDC>62332-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091367</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>62332-045-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (62332-045-30) </PackageDescription>
<NDC11Code>62332-0045-30</NDC11Code>
<ProductNDC>62332-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091367</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>62332-045-71</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (62332-045-71) </PackageDescription>
<NDC11Code>62332-0045-71</NDC11Code>
<ProductNDC>62332-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091367</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>62332-045-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62332-045-90) </PackageDescription>
<NDC11Code>62332-0045-90</NDC11Code>
<ProductNDC>62332-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091367</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>62332-045-91</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (62332-045-91) </PackageDescription>
<NDC11Code>62332-0045-91</NDC11Code>
<ProductNDC>62332-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091367</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>65302-045-01</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (65302-045-01) > 1 AMPULE in 1 POUCH > 3 mL in 1 AMPULE</PackageDescription>
<NDC11Code>65302-0045-01</NDC11Code>
<ProductNDC>65302-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20181226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077839</ApplicationNumber>
<LabelerName>The Ritedose Corporation</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70594-045-03</NDCCode>
<PackageDescription>25 CARTON in 1 CARTON (70594-045-03) > 10 VIAL, GLASS in 1 CARTON (70594-045-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-045-01) </PackageDescription>
<NDC11Code>70594-0045-03</NDC11Code>
<ProductNDC>70594-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204107</ApplicationNumber>
<LabelerName>Xellia Pharmaceuticals USA LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomem-branous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, mono-hydrochloride. The molecular formula is C66H75Cl2N9O24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>72028-045-03</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>72028-0045-03</NDC11Code>
<ProductNDC>72028-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wakix</ProprietaryName>
<NonProprietaryName>Pitolisant Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190814</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211150</ApplicationNumber>
<LabelerName>Harmony Biosciences, LLC</LabelerName>
<SubstanceName>PITOLISANT HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4.45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inducers [MoA], Histamine H3 Receptor Antagonists [MoA], Histamine H3 Receptor Inverse Agonists [MoA], Histamine-3 Receptor Antagonist/Inverse Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.</IndicationAndUsage>
<Description>WAKIX tablets contain pitolisant hydrochloride. Pitolisant is an antagonist/inverse agonist of the histamine-3 (H3) receptor. Pitolisant hydrochloride is a white or almost white crystalline powder with a molecular formula of C17H26ClNO·HCl and a molecular weight of 332.31. Pitolisant hydrochloride is soluble in water, ethanol, and methylene chloride and practically insoluble in cyclohexane. The chemical name of pitolisant hydrochloride is 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride and its structural formula is. The molecular formula of the pitolisant free base is C17H26ClNO and its molecular weight is 295.85. WAKIX tablets are for oral administration and each film-coated tablet contains 5 mg or 20 mg of pitolisant hydrochloride (equivalent to 4.45 mg or 17.8 mg of pitolisant free base, respectively) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>74530-045-01</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (74530-045-01) </PackageDescription>
<NDC11Code>74530-0045-01</NDC11Code>
<ProductNDC>74530-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Marvel Avengers Hand Sanitizer With Case</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200925</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Best Brand Consumers Products, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease the bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84951-012-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (84951-012-01) / 245 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>84951-0012-01</NDC11Code>
<ProductNDC>84951-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anbiser B-ha Hyaluronic Acid Nourishing Body Wash</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Qingdao Huinorde Biotechnology Co., LTD</LabelerName>
<SubstanceName>.ALPHA.-GLUCAN OLIGOSACCHARIDE; BUTYLENE GLYCOL; GLYCERIN; HEXYLENE GLYCOL; HYALURONATE SODIUM</SubstanceName>
<StrengthNumber>.03; .045; 10; .05; .006</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This body wash offers a luxurious fragrance while hydrating the skin. Formulated with small molecule hyaluronic acid and plant-based ingredients, it replenishes moisture and provides long-lasting hydration to the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81968-020-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (81968-020-02) / 2 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>81968-0020-02</NDC11Code>
<ProductNDC>81968-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbravo</ProprietaryName>
<NonProprietaryName>Meloxicam, Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215431</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>MELOXICAM; RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251121</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>81968-020-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (81968-020-03) / 3 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>81968-0020-03</NDC11Code>
<ProductNDC>81968-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbravo</ProprietaryName>
<NonProprietaryName>Meloxicam, Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215431</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>MELOXICAM; RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250519</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>81968-020-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE (81968-020-09) </PackageDescription>
<NDC11Code>81968-0020-09</NDC11Code>
<ProductNDC>81968-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbravo</ProprietaryName>
<NonProprietaryName>Meloxicam, Rizatriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215431</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>MELOXICAM; RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81968-030-22</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (81968-030-22) / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>81968-0030-22</NDC11Code>
<ProductNDC>81968-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260508</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260508</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>81968-345-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (81968-345-01) * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>81968-0345-01</NDC11Code>
<ProductNDC>81968-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>81968-345-03</NDCCode>
<PackageDescription>1 KIT in 1 KIT (81968-345-03) * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>81968-0345-03</NDC11Code>
<ProductNDC>81968-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
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