{
"NDC": [
{
"NDCCode": "49502-672-30",
"PackageDescription": "6 POUCH in 1 CARTON (49502-672-30) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL",
"NDC11Code": "49502-0672-30",
"ProductNDC": "49502-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duoneb",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020950",
"LabelerName": "Mylan Specialty",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 2.5",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49502-672-60",
"PackageDescription": "12 POUCH in 1 CARTON (49502-672-60) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL",
"NDC11Code": "49502-0672-60",
"ProductNDC": "49502-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duoneb",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020950",
"LabelerName": "Mylan Specialty",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 2.5",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49502-425-93",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (49502-425-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "49502-0425-93",
"ProductNDC": "49502-425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symfi Lo",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180313",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208255",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "400; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180313",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "SYMFI LO® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
"Description": "SYMFI LO (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a fixed-dose combination tablet for oral administration. Each tablet contains 400 mg of efavirenz, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide. Efavirenz: Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is:. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine: Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine is a white to off-white solid with a solubility of approximately 70 mg per mL in water at 20°C. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of TDF is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.51. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder that is freely soluble in dimethylformamide and soluble in methanol. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C."
},
{
"NDCCode": "49502-450-93",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "49502-0450-93",
"ProductNDC": "49502-450",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cimduo",
"NonProprietaryName": "Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180625",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022141",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "300; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180625",
"SamplePackage": "N",
"IndicationAndUsage": "CIMDUO® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
"Description": "CIMDUO tablets contain lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate or tenofovir DF, a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester prodrug of tenofovir. In vivo tenofovir DF is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of lamivudine is (-)-1-[2R,5S)-2-Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine is a white to off-white solid with a solubility of approximately 70 mg per mL in water at 20°C. The chemical name of tenofovir DF is 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.51. It has the following structural formula. Tenofovir DF is a white to off-white powder with a solubility of 13.4 mg/mL in distilled water at 25°C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C. CIMDUO tablets are for oral administration. Each film-coated tablet contains 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating contains polyethylene glycol, titanium dioxide, polyvinyl alcohol and talc."
},
{
"NDCCode": "49502-475-93",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "49502-0475-93",
"ProductNDC": "49502-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symfi",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022142",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180425",
"SamplePackage": "N",
"IndicationAndUsage": "SYMFI® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.",
"Description": "SYMFI tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. SYMFI tablets are for oral administration. Each film-coated tablet contains 600 mg of efavirenz, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium chloride, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (4S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is:. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine is a white to off-white solid with a solubility of approximately 70 mg per mL in water at 20°C. Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.51. It has the following structural formula. Tenofovir DF is a white to off-white powder with a solubility of 13.4 mg/mL in distilled water at 25°C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C."
},
{
"NDCCode": "49502-605-30",
"PackageDescription": "30 POUCH in 1 CARTON (49502-605-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL",
"NDC11Code": "49502-0605-30",
"ProductNDC": "49502-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perforomist",
"NonProprietaryName": "Formoterol Fumarate Dihydrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022007",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "FORMOTEROL FUMARATE",
"StrengthNumber": "20",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071001",
"SamplePackage": "N",
"IndicationAndUsage": "PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
},
{
"NDCCode": "49502-806-93",
"PackageDescription": "30 POUCH in 1 CARTON (49502-806-93) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-32) / 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "49502-0806-93",
"ProductNDC": "49502-806",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yupelri",
"NonProprietaryName": "Revefenacin",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20181203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210598",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "REVEFENACIN",
"StrengthNumber": "175",
"StrengthUnit": "ug/3mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181203",
"SamplePackage": "N",
"IndicationAndUsage": "YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).",
"Description": "YUPELRI is a sterile, clear, colorless, aqueous solution of revefenacin. Revefenacin, the active component of YUPELRI, is an anticholinergic. The chemical name for revefenacin is 1-(2-{4-[(4-carbamoylpiperidin-1-yl)methyl]-N-methylbenzamido}ethyl)piperidin-4-yl N-({1,1’-biphenyl}-2-yl)carbamate; its structural formula is. Revefenacin has a molecular weight of 597.76 and its empirical formula is C35H43N5O4. Revefenacin is a white to off-white crystalline powder and is slightly soluble in water. YUPELRI is supplied as 3 mL of revefenacin solution packaged in a unit-dose low-density polyethylene vial overwrapped in a foil pouch. Each vial contains 175 mcg of revefenacin in 3 mL of an isotonic, sterile aqueous solution containing citric acid, sodium chloride, sodium citrate, and water for injection at pH 5.0. Hydrochloric acid or sodium hydroxide may be used to adjust the pH. YUPELRI does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the nebulization system used, and compressor performance. Using the PARI LC® Sprint nebulizer connected to a PARI Trek® S compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 62 mcg (35% of label claim), at a mean flow rate of 4 LPM. The mean nebulization time was 8 minutes. YUPELRI should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow, and equipped with a mouthpiece."
},
{
"NDCCode": "49502-900-30",
"PackageDescription": "30 POUCH in 1 CARTON (49502-900-30) / 1 PATCH in 1 POUCH (49502-900-01) / 24 h in 1 PATCH",
"NDC11Code": "49502-0900-30",
"ProductNDC": "49502-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emsam",
"NonProprietaryName": "Selegiline",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20060227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021336",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "SELEGILINE",
"StrengthNumber": "6",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060227",
"SamplePackage": "N",
"IndicationAndUsage": "EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "EMSAM® contains selegiline, a MAOI antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl-N-[(1R)-1-methyl-2-phenylethyl]prop-2-yn-1-amine. It has a molecular formula of C13H17N and a molecular weight of 187.30. The structural formula is. EMSAM transdermal systems are available in three strengths that deliver approximately 6 mg, 9 mg, or 12 mg of selegiline over 24 hours. Each corresponding system has an active surface area of 20 cm2, 30 cm2, or 40 cm2 containing 20, 30, or 40 mg of selegiline, respectively. The composition of the systems per unit area is identical. EMSAM is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 is the Backing Film that provides occlusivity, physical integrity and protects the adhesive/drug layer. Layer 2 is the Adhesive/Drug Layer. Layer 3 consists of side-by-side release liners that are peeled off and discarded by the patient prior to applying EMSAM. The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene, polyester, polyurethane, and silicone coated polyester."
},
{
"NDCCode": "49502-901-30",
"PackageDescription": "30 POUCH in 1 CARTON (49502-901-30) / 1 PATCH in 1 POUCH (49502-901-01) / 24 h in 1 PATCH",
"NDC11Code": "49502-0901-30",
"ProductNDC": "49502-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emsam",
"NonProprietaryName": "Selegiline",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20060227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021336",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "SELEGILINE",
"StrengthNumber": "9",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060227",
"SamplePackage": "N",
"IndicationAndUsage": "EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "EMSAM® contains selegiline, a MAOI antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl-N-[(1R)-1-methyl-2-phenylethyl]prop-2-yn-1-amine. It has a molecular formula of C13H17N and a molecular weight of 187.30. The structural formula is. EMSAM transdermal systems are available in three strengths that deliver approximately 6 mg, 9 mg, or 12 mg of selegiline over 24 hours. Each corresponding system has an active surface area of 20 cm2, 30 cm2, or 40 cm2 containing 20, 30, or 40 mg of selegiline, respectively. The composition of the systems per unit area is identical. EMSAM is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 is the Backing Film that provides occlusivity, physical integrity and protects the adhesive/drug layer. Layer 2 is the Adhesive/Drug Layer. Layer 3 consists of side-by-side release liners that are peeled off and discarded by the patient prior to applying EMSAM. The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene, polyester, polyurethane, and silicone coated polyester."
},
{
"NDCCode": "49502-902-30",
"PackageDescription": "30 POUCH in 1 CARTON (49502-902-30) / 1 PATCH in 1 POUCH (49502-902-01) / 24 h in 1 PATCH",
"NDC11Code": "49502-0902-30",
"ProductNDC": "49502-902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emsam",
"NonProprietaryName": "Selegiline",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20060227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021336",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "SELEGILINE",
"StrengthNumber": "12",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060227",
"SamplePackage": "N",
"IndicationAndUsage": "EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "EMSAM® contains selegiline, a MAOI antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl-N-[(1R)-1-methyl-2-phenylethyl]prop-2-yn-1-amine. It has a molecular formula of C13H17N and a molecular weight of 187.30. The structural formula is. EMSAM transdermal systems are available in three strengths that deliver approximately 6 mg, 9 mg, or 12 mg of selegiline over 24 hours. Each corresponding system has an active surface area of 20 cm2, 30 cm2, or 40 cm2 containing 20, 30, or 40 mg of selegiline, respectively. The composition of the systems per unit area is identical. EMSAM is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 is the Backing Film that provides occlusivity, physical integrity and protects the adhesive/drug layer. Layer 2 is the Adhesive/Drug Layer. Layer 3 consists of side-by-side release liners that are peeled off and discarded by the patient prior to applying EMSAM. The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene, polyester, polyurethane, and silicone coated polyester."
},
{
"NDCCode": "10135-672-99",
"PackageDescription": "1 TUBE in 1 CARTON (10135-672-99) / 30 g in 1 TUBE",
"NDC11Code": "10135-0672-99",
"ProductNDC": "10135-672",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations."
},
{
"NDCCode": "13537-672-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-672-02) > 30 g in 1 TUBE (13537-672-01)",
"NDC11Code": "13537-0672-02",
"ProductNDC": "13537-672",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 16 Base Textura Mousse Acabado Mate Fps 16",
"ProprietaryNameSuffix": "Claire 3- Beige",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13811-672-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13811-672-30)",
"NDC11Code": "13811-0672-30",
"ProductNDC": "13811-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078932",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "17224-672-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (17224-672-30) ",
"NDC11Code": "17224-0672-30",
"ProductNDC": "17224-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzphetamine Hydrochloride",
"NonProprietaryName": "Benzphetamine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090968",
"LabelerName": "Calvin Scott & Co., Inc.",
"SubstanceName": "BENZPHETAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2023-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100101",
"SamplePackage": "N",
"IndicationAndUsage": "Benzphetamine hydrochloride tablets, USP are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine hydrochloride tablets, USP are indicated for use as monotherapy only.",
"Description": "Benzphetamine hydrochloride tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N,α-Dimethyl-N -(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each benzphetamine hydrochloride tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: carnauba wax powder, colloidal silicon dioxide, FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose 101, polyvinyl alcohol – partially hydrolyzed, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "21695-672-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-672-30)",
"NDC11Code": "21695-0672-30",
"ProductNDC": "21695-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040663",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin sodium tablets are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium tablet (crystalline warfarin sodium) is an anticoagulant, which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its molecular formula is C19H15NaO4, and its structural formula may be represented by the following. Crystalline warfarin sodium occurs as a white crystalline powder, odorless or practically odorless. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and pregelatinized starch. Additionally each 1 mg tablet contains D&C red no. 6 barium lake, 2 mg tablet contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake, 2.5 mg tablet contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake, 3 mg tablet contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake, 4 mg tablet contains FD&C blue no. 1 aluminum lake, 5 mg tablet contains FD&C yellow no. 6 aluminum lake, 6 mg tablet contains FD&C yellow no. 6 aluminum lake and FD&C blue no. 1 aluminum lake, 7.5 mg tablet contains D&C yellow no. 10 aluminum lake and FD&C yellow no.6 aluminum lake and 10 mg tablet is dye free."
},
{
"NDCCode": "33261-672-30",
"PackageDescription": "30 POUCH in 1 CARTON (33261-672-30) > 1 PATCH in 1 POUCH",
"NDC11Code": "33261-0672-30",
"ProductNDC": "33261-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidoderm",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "19990320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020612",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "700",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "35356-672-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-672-30)",
"NDC11Code": "35356-0672-30",
"ProductNDC": "35356-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040185",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "42549-672-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42549-672-30)",
"NDC11Code": "42549-0672-30",
"ProductNDC": "42549-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076765",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .",
"Description": "Escitalopram tablets USP is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. C20H21FN2O C2H2O4 M.W. 414.40. Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP are film-coated, round tablets containing escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "43547-672-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-672-03) ",
"NDC11Code": "43547-0672-03",
"ProductNDC": "43547-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan And Hydrochlorothiazide",
"NonProprietaryName": "Irbesartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203072",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE; IRBESARTAN",
"StrengthNumber": "25; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140301",
"SamplePackage": "N"
},
{
"NDCCode": "43598-672-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43598-672-30) ",
"NDC11Code": "43598-0672-30",
"ProductNDC": "43598-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrimethamine",
"NonProprietaryName": "Pyrimethamine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207127",
"LabelerName": "DR.REDDYS LABORATORIES INC",
"SubstanceName": "PYRIMETHAMINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200316",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Toxoplasmosis: Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.",
"Description": "Pyrimethamine is an antiparasitic compound available in tablet form for oral administration. Each scored tablet contains 25 mg pyrimethamine and the inactive ingredients pregelatinized starch, lactose monohydrate, and magnesium stearate. Pyrimethamine, known chemically as 5-(4-chlorophenyl)-6-ethyl-2,4-pyrimidinediamine, has the following structural formula:. C12H13CIN4. Mol. Wt. 248.71. “FDA approved dissolution test specifications differ from USP”."
},
{
"NDCCode": "43602-672-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (43602-672-30) ",
"NDC11Code": "43602-0672-30",
"ProductNDC": "43602-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218939",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250114",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white to creamy-white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.24. Levodopa, USP an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (2S)-2-Amino-3-(3,4-dihydroxyphenyl) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/100 mg containing 10 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets, USP 25 mg/100 mg containing 25 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets, USP 25 mg/250 mg containing 25 mg of carbidopa USP and 250 mg of levodopa USP. Inactive ingredients are microcrystalline cellulose, pregelatinized starch (maize), crospovidone, hydroxypropyl cellulose and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/250 mg also contain FD&C Blue No.2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow No.10. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "47335-672-83",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-672-83) ",
"NDC11Code": "47335-0672-83",
"ProductNDC": "47335-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090421",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25."
},
{
"NDCCode": "51407-672-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51407-672-30) ",
"NDC11Code": "51407-0672-30",
"ProductNDC": "51407-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine, Valsartan, Hydrochlorothiazide",
"NonProprietaryName": "Amlodipine Besylate Valsartan Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201087",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
"StrengthNumber": "10; 25; 320",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine/valsartan/hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitation of Use. Amlodipine/valsartan/hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].",
"Description": "Amlodipine/valsartan/hydrochlorothiazide is a fixed combination of amlodipine, valsartan and hydrochlorothiazide. Amlodipine/valsartan/hydrochlorothiazide contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]4-( o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is:. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is:. Its empirical formula is C 24H 29N 5O 3and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C 7H 8ClN 3O 4S 2, its molecular weight is 297.73, and its structural formula is:. Amlodipine/valsartan/hydrochlorothiazide film-coated tablets are formulated in five strengths for oral administration with a combination of amlodipine besylate, valsartan and hydrochlorothiazide, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg amlodipine besylate/valsartan/hydrochlo rothiazide. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate, Additionally, the 5/160/12.5 mgstrength contains polyethylene glycol, polyvinyl alcohol, titanium dioxide and talc; the 10/320/25 mgstrength contains the same ingredients as the 5/160/12.5 mgstrength; the 5/160/25 mgstrength contains lactose monohydrate, hypromellose, triacetin, D&C Yellow #10, titanium dioxide, and FD&C Yellow #6; the 10/160/12.5 mgstrength contains FD&C Yellow #6, triethyl citrate, yellow iron oxide, hypromellose and titanium dioxide, lactose monohydrate; and the 10/160/25 mgstrength contains hypromellose, titanium dioxide, D&C Yellow #10, macrogol and polysorbate."
},
{
"NDCCode": "52427-672-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (52427-672-30) ",
"NDC11Code": "52427-0672-30",
"ProductNDC": "52427-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hcl",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215133",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.",
"Description": "Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives."
},
{
"NDCCode": "54864-672-15",
"PackageDescription": "30 kg in 1 DRUM (54864-672-15) ",
"NDC11Code": "54864-0672-15",
"ProductNDC": "54864-672",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dapagliflozin Propanediol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140116",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DOTTIKON EXCLUSIVE SYNTHESIS AG",
"SubstanceName": "DAPAGLIFLOZIN PROPANEDIOL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-24",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "16-JAN-14"
},
{
"NDCCode": "54864-672-64",
"PackageDescription": "30 kg in 1 DRUM (54864-672-64) ",
"NDC11Code": "54864-0672-64",
"ProductNDC": "54864-672",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dapagliflozin Propanediol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140116",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DOTTIKON EXCLUSIVE SYNTHESIS AG",
"SubstanceName": "DAPAGLIFLOZIN PROPANEDIOL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-24",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "16-JAN-14"
},
{
"NDCCode": "55700-672-30",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (55700-672-30) ",
"NDC11Code": "55700-0672-30",
"ProductNDC": "55700-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090469",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ONDANSETRON",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180914",
"SamplePackage": "N"
},
{
"NDCCode": "55700-672-65",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (55700-672-65) ",
"NDC11Code": "55700-0672-65",
"ProductNDC": "55700-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090469",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ONDANSETRON",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180914",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy, 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen .",
"Description": "The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula: The molecular formula is C18H19N3O representing a molecular weight of 293.4. Ondansetron is a white to off-white powder. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing. This product does not meet USP Disintegration Time. The 4 mg and 8 mg tablets disintegrate in approximately 60 seconds."
},
{
"NDCCode": "58411-672-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (58411-672-10) / 30 mL in 1 BOTTLE",
"NDC11Code": "58411-0672-10",
"ProductNDC": "58411-672",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "1.8; 5",
"StrengthUnit": "g/30mL; g/30mL",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220101",
"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": "59746-672-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (59746-672-30)",
"NDC11Code": "59746-0672-30",
"ProductNDC": "59746-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209605",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "TIZANIDINE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Tizanidine hydrochloride capsules are central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].",
"Description": "Tizanidine hydrochloride is central alpha2-adrenergic agonist. Tizanidine HCl USP is a almost white to slightly yellow, crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C9H8ClN5S-HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine hydrochloride capsules are supplied as 2 mg , 4 mg, and 6 mg capsules for oral administration. Tizanidine hydrochloride capsules contain the active ingredient, tizanidine hydrochloride USP (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg equivalent to 4 mg tizanidine base, and 6.87 mg equivalent to 6 mg tizanidine base), and the inactive ingredients, anhydrous lactose, FD&C blue #2, gelatin, methacrylic acid copolymer, stearic acid and titanium dioxide. The imprinting ink contains ferric oxide black, potassium hydroxide, propylene glycol and shellac."
}
]
}
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<NDC>
<NDCCode>49502-672-30</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (49502-672-30) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>49502-0672-30</NDC11Code>
<ProductNDC>49502-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duoneb</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020950</ApplicationNumber>
<LabelerName>Mylan Specialty</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.5; 2.5</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
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<NDC>
<NDCCode>49502-672-60</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (49502-672-60) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>49502-0672-60</NDC11Code>
<ProductNDC>49502-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duoneb</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020950</ApplicationNumber>
<LabelerName>Mylan Specialty</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.5; 2.5</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49502-425-93</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (49502-425-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>49502-0425-93</NDC11Code>
<ProductNDC>49502-425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symfi Lo</ProprietaryName>
<NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180313</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208255</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>400; 300; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180313</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMFI LO® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.</IndicationAndUsage>
<Description>SYMFI LO (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a fixed-dose combination tablet for oral administration. Each tablet contains 400 mg of efavirenz, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide. Efavirenz: Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is:. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine: Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine is a white to off-white solid with a solubility of approximately 70 mg per mL in water at 20°C. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of TDF is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.51. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder that is freely soluble in dimethylformamide and soluble in methanol. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>49502-450-93</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>49502-0450-93</NDC11Code>
<ProductNDC>49502-450</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cimduo</ProprietaryName>
<NonProprietaryName>Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180625</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022141</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>300; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CIMDUO® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.</IndicationAndUsage>
<Description>CIMDUO tablets contain lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate or tenofovir DF, a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester prodrug of tenofovir. In vivo tenofovir DF is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of lamivudine is (-)-1-[2R,5S)-2-Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine is a white to off-white solid with a solubility of approximately 70 mg per mL in water at 20°C. The chemical name of tenofovir DF is 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.51. It has the following structural formula. Tenofovir DF is a white to off-white powder with a solubility of 13.4 mg/mL in distilled water at 25°C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C. CIMDUO tablets are for oral administration. Each film-coated tablet contains 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating contains polyethylene glycol, titanium dioxide, polyvinyl alcohol and talc.</Description>
</NDC>
<NDC>
<NDCCode>49502-475-93</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>49502-0475-93</NDC11Code>
<ProductNDC>49502-475</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symfi</ProprietaryName>
<NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022142</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>600; 300; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMFI® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>SYMFI tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. SYMFI tablets are for oral administration. Each film-coated tablet contains 600 mg of efavirenz, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium chloride, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (4S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is:. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine is a white to off-white solid with a solubility of approximately 70 mg per mL in water at 20°C. Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.51. It has the following structural formula. Tenofovir DF is a white to off-white powder with a solubility of 13.4 mg/mL in distilled water at 25°C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>49502-605-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (49502-605-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>49502-0605-30</NDC11Code>
<ProductNDC>49502-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perforomist</ProprietaryName>
<NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022007</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.</Description>
</NDC>
<NDC>
<NDCCode>49502-806-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (49502-806-93) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-32) / 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>49502-0806-93</NDC11Code>
<ProductNDC>49502-806</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yupelri</ProprietaryName>
<NonProprietaryName>Revefenacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20181203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210598</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>REVEFENACIN</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/3mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</IndicationAndUsage>
<Description>YUPELRI is a sterile, clear, colorless, aqueous solution of revefenacin. Revefenacin, the active component of YUPELRI, is an anticholinergic. The chemical name for revefenacin is 1-(2-{4-[(4-carbamoylpiperidin-1-yl)methyl]-N-methylbenzamido}ethyl)piperidin-4-yl N-({1,1’-biphenyl}-2-yl)carbamate; its structural formula is. Revefenacin has a molecular weight of 597.76 and its empirical formula is C35H43N5O4. Revefenacin is a white to off-white crystalline powder and is slightly soluble in water. YUPELRI is supplied as 3 mL of revefenacin solution packaged in a unit-dose low-density polyethylene vial overwrapped in a foil pouch. Each vial contains 175 mcg of revefenacin in 3 mL of an isotonic, sterile aqueous solution containing citric acid, sodium chloride, sodium citrate, and water for injection at pH 5.0. Hydrochloric acid or sodium hydroxide may be used to adjust the pH. YUPELRI does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the nebulization system used, and compressor performance. Using the PARI LC® Sprint nebulizer connected to a PARI Trek® S compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 62 mcg (35% of label claim), at a mean flow rate of 4 LPM. The mean nebulization time was 8 minutes. YUPELRI should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow, and equipped with a mouthpiece.</Description>
</NDC>
<NDC>
<NDCCode>49502-900-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (49502-900-30) / 1 PATCH in 1 POUCH (49502-900-01) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>49502-0900-30</NDC11Code>
<ProductNDC>49502-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emsam</ProprietaryName>
<NonProprietaryName>Selegiline</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20060227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021336</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>SELEGILINE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>EMSAM® contains selegiline, a MAOI antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl-N-[(1R)-1-methyl-2-phenylethyl]prop-2-yn-1-amine. It has a molecular formula of C13H17N and a molecular weight of 187.30. The structural formula is. EMSAM transdermal systems are available in three strengths that deliver approximately 6 mg, 9 mg, or 12 mg of selegiline over 24 hours. Each corresponding system has an active surface area of 20 cm2, 30 cm2, or 40 cm2 containing 20, 30, or 40 mg of selegiline, respectively. The composition of the systems per unit area is identical. EMSAM is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 is the Backing Film that provides occlusivity, physical integrity and protects the adhesive/drug layer. Layer 2 is the Adhesive/Drug Layer. Layer 3 consists of side-by-side release liners that are peeled off and discarded by the patient prior to applying EMSAM. The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene, polyester, polyurethane, and silicone coated polyester.</Description>
</NDC>
<NDC>
<NDCCode>49502-901-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (49502-901-30) / 1 PATCH in 1 POUCH (49502-901-01) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>49502-0901-30</NDC11Code>
<ProductNDC>49502-901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emsam</ProprietaryName>
<NonProprietaryName>Selegiline</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20060227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021336</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>SELEGILINE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>EMSAM® contains selegiline, a MAOI antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl-N-[(1R)-1-methyl-2-phenylethyl]prop-2-yn-1-amine. It has a molecular formula of C13H17N and a molecular weight of 187.30. The structural formula is. EMSAM transdermal systems are available in three strengths that deliver approximately 6 mg, 9 mg, or 12 mg of selegiline over 24 hours. Each corresponding system has an active surface area of 20 cm2, 30 cm2, or 40 cm2 containing 20, 30, or 40 mg of selegiline, respectively. The composition of the systems per unit area is identical. EMSAM is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 is the Backing Film that provides occlusivity, physical integrity and protects the adhesive/drug layer. Layer 2 is the Adhesive/Drug Layer. Layer 3 consists of side-by-side release liners that are peeled off and discarded by the patient prior to applying EMSAM. The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene, polyester, polyurethane, and silicone coated polyester.</Description>
</NDC>
<NDC>
<NDCCode>49502-902-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (49502-902-30) / 1 PATCH in 1 POUCH (49502-902-01) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>49502-0902-30</NDC11Code>
<ProductNDC>49502-902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emsam</ProprietaryName>
<NonProprietaryName>Selegiline</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20060227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021336</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>SELEGILINE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>EMSAM® contains selegiline, a MAOI antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl-N-[(1R)-1-methyl-2-phenylethyl]prop-2-yn-1-amine. It has a molecular formula of C13H17N and a molecular weight of 187.30. The structural formula is. EMSAM transdermal systems are available in three strengths that deliver approximately 6 mg, 9 mg, or 12 mg of selegiline over 24 hours. Each corresponding system has an active surface area of 20 cm2, 30 cm2, or 40 cm2 containing 20, 30, or 40 mg of selegiline, respectively. The composition of the systems per unit area is identical. EMSAM is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 is the Backing Film that provides occlusivity, physical integrity and protects the adhesive/drug layer. Layer 2 is the Adhesive/Drug Layer. Layer 3 consists of side-by-side release liners that are peeled off and discarded by the patient prior to applying EMSAM. The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene, polyester, polyurethane, and silicone coated polyester.</Description>
</NDC>
<NDC>
<NDCCode>10135-672-99</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10135-672-99) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>10135-0672-99</NDC11Code>
<ProductNDC>10135-672</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-672-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-672-02) > 30 g in 1 TUBE (13537-672-01)</PackageDescription>
<NDC11Code>13537-0672-02</NDC11Code>
<ProductNDC>13537-672</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 16 Base Textura Mousse Acabado Mate Fps 16</ProprietaryName>
<ProprietaryNameSuffix>Claire 3- Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13811-672-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13811-672-30)</PackageDescription>
<NDC11Code>13811-0672-30</NDC11Code>
<ProductNDC>13811-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078932</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>17224-672-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (17224-672-30) </PackageDescription>
<NDC11Code>17224-0672-30</NDC11Code>
<ProductNDC>17224-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090968</ApplicationNumber>
<LabelerName>Calvin Scott & Co., Inc.</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzphetamine hydrochloride tablets, USP are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine hydrochloride tablets, USP are indicated for use as monotherapy only.</IndicationAndUsage>
<Description>Benzphetamine hydrochloride tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N,α-Dimethyl-N -(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each benzphetamine hydrochloride tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: carnauba wax powder, colloidal silicon dioxide, FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose 101, polyvinyl alcohol – partially hydrolyzed, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-672-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-672-30)</PackageDescription>
<NDC11Code>21695-0672-30</NDC11Code>
<ProductNDC>21695-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040663</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin sodium tablets are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium tablet (crystalline warfarin sodium) is an anticoagulant, which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its molecular formula is C19H15NaO4, and its structural formula may be represented by the following. Crystalline warfarin sodium occurs as a white crystalline powder, odorless or practically odorless. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and pregelatinized starch. Additionally each 1 mg tablet contains D&C red no. 6 barium lake, 2 mg tablet contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake, 2.5 mg tablet contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake, 3 mg tablet contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake, 4 mg tablet contains FD&C blue no. 1 aluminum lake, 5 mg tablet contains FD&C yellow no. 6 aluminum lake, 6 mg tablet contains FD&C yellow no. 6 aluminum lake and FD&C blue no. 1 aluminum lake, 7.5 mg tablet contains D&C yellow no. 10 aluminum lake and FD&C yellow no.6 aluminum lake and 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>33261-672-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (33261-672-30) > 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>33261-0672-30</NDC11Code>
<ProductNDC>33261-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidoderm</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>19990320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020612</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>35356-672-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-672-30)</PackageDescription>
<NDC11Code>35356-0672-30</NDC11Code>
<ProductNDC>35356-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040185</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42549-672-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42549-672-30)</PackageDescription>
<NDC11Code>42549-0672-30</NDC11Code>
<ProductNDC>42549-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .</IndicationAndUsage>
<Description>Escitalopram tablets USP is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. C20H21FN2O C2H2O4 M.W. 414.40. Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP are film-coated, round tablets containing escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-672-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-672-03) </PackageDescription>
<NDC11Code>43547-0672-03</NDC11Code>
<ProductNDC>43547-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Irbesartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203072</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; IRBESARTAN</SubstanceName>
<StrengthNumber>25; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43598-672-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43598-672-30) </PackageDescription>
<NDC11Code>43598-0672-30</NDC11Code>
<ProductNDC>43598-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrimethamine</ProprietaryName>
<NonProprietaryName>Pyrimethamine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207127</ApplicationNumber>
<LabelerName>DR.REDDYS LABORATORIES INC</LabelerName>
<SubstanceName>PYRIMETHAMINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Toxoplasmosis: Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.</IndicationAndUsage>
<Description>Pyrimethamine is an antiparasitic compound available in tablet form for oral administration. Each scored tablet contains 25 mg pyrimethamine and the inactive ingredients pregelatinized starch, lactose monohydrate, and magnesium stearate. Pyrimethamine, known chemically as 5-(4-chlorophenyl)-6-ethyl-2,4-pyrimidinediamine, has the following structural formula:. C12H13CIN4. Mol. Wt. 248.71. “FDA approved dissolution test specifications differ from USP”.</Description>
</NDC>
<NDC>
<NDCCode>43602-672-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43602-672-30) </PackageDescription>
<NDC11Code>43602-0672-30</NDC11Code>
<ProductNDC>43602-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218939</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white to creamy-white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.24. Levodopa, USP an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (2S)-2-Amino-3-(3,4-dihydroxyphenyl) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/100 mg containing 10 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets, USP 25 mg/100 mg containing 25 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets, USP 25 mg/250 mg containing 25 mg of carbidopa USP and 250 mg of levodopa USP. Inactive ingredients are microcrystalline cellulose, pregelatinized starch (maize), crospovidone, hydroxypropyl cellulose and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/250 mg also contain FD&C Blue No.2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow No.10. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>47335-672-83</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-672-83) </PackageDescription>
<NDC11Code>47335-0672-83</NDC11Code>
<ProductNDC>47335-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090421</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25.</Description>
</NDC>
<NDC>
<NDCCode>51407-672-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51407-672-30) </PackageDescription>
<NDC11Code>51407-0672-30</NDC11Code>
<ProductNDC>51407-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201087</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 25; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine/valsartan/hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitation of Use. Amlodipine/valsartan/hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Amlodipine/valsartan/hydrochlorothiazide is a fixed combination of amlodipine, valsartan and hydrochlorothiazide. Amlodipine/valsartan/hydrochlorothiazide contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]4-( o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is:. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is:. Its empirical formula is C 24H 29N 5O 3and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C 7H 8ClN 3O 4S 2, its molecular weight is 297.73, and its structural formula is:. Amlodipine/valsartan/hydrochlorothiazide film-coated tablets are formulated in five strengths for oral administration with a combination of amlodipine besylate, valsartan and hydrochlorothiazide, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg amlodipine besylate/valsartan/hydrochlo rothiazide. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate, Additionally, the 5/160/12.5 mgstrength contains polyethylene glycol, polyvinyl alcohol, titanium dioxide and talc; the 10/320/25 mgstrength contains the same ingredients as the 5/160/12.5 mgstrength; the 5/160/25 mgstrength contains lactose monohydrate, hypromellose, triacetin, D&C Yellow #10, titanium dioxide, and FD&C Yellow #6; the 10/160/12.5 mgstrength contains FD&C Yellow #6, triethyl citrate, yellow iron oxide, hypromellose and titanium dioxide, lactose monohydrate; and the 10/160/25 mgstrength contains hypromellose, titanium dioxide, D&C Yellow #10, macrogol and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>52427-672-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (52427-672-30) </PackageDescription>
<NDC11Code>52427-0672-30</NDC11Code>
<ProductNDC>52427-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hcl</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215133</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives.</Description>
</NDC>
<NDC>
<NDCCode>54864-672-15</NDCCode>
<PackageDescription>30 kg in 1 DRUM (54864-672-15) </PackageDescription>
<NDC11Code>54864-0672-15</NDC11Code>
<ProductNDC>54864-672</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dapagliflozin Propanediol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140116</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DOTTIKON EXCLUSIVE SYNTHESIS AG</LabelerName>
<SubstanceName>DAPAGLIFLOZIN PROPANEDIOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-24</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-JAN-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>54864-672-64</NDCCode>
<PackageDescription>30 kg in 1 DRUM (54864-672-64) </PackageDescription>
<NDC11Code>54864-0672-64</NDC11Code>
<ProductNDC>54864-672</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dapagliflozin Propanediol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140116</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DOTTIKON EXCLUSIVE SYNTHESIS AG</LabelerName>
<SubstanceName>DAPAGLIFLOZIN PROPANEDIOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-24</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-JAN-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55700-672-30</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (55700-672-30) </PackageDescription>
<NDC11Code>55700-0672-30</NDC11Code>
<ProductNDC>55700-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090469</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-672-65</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (55700-672-65) </PackageDescription>
<NDC11Code>55700-0672-65</NDC11Code>
<ProductNDC>55700-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090469</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180914</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy, 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen .</IndicationAndUsage>
<Description>The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula: The molecular formula is C18H19N3O representing a molecular weight of 293.4. Ondansetron is a white to off-white powder. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing. This product does not meet USP Disintegration Time. The 4 mg and 8 mg tablets disintegrate in approximately 60 seconds.</Description>
</NDC>
<NDC>
<NDCCode>58411-672-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58411-672-10) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58411-0672-10</NDC11Code>
<ProductNDC>58411-672</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.8; 5</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</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>59746-672-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (59746-672-30)</PackageDescription>
<NDC11Code>59746-0672-30</NDC11Code>
<ProductNDC>59746-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209605</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TIZANIDINE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tizanidine hydrochloride capsules are central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].</IndicationAndUsage>
<Description>Tizanidine hydrochloride is central alpha2-adrenergic agonist. Tizanidine HCl USP is a almost white to slightly yellow, crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C9H8ClN5S-HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine hydrochloride capsules are supplied as 2 mg , 4 mg, and 6 mg capsules for oral administration. Tizanidine hydrochloride capsules contain the active ingredient, tizanidine hydrochloride USP (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg equivalent to 4 mg tizanidine base, and 6.87 mg equivalent to 6 mg tizanidine base), and the inactive ingredients, anhydrous lactose, FD&C blue #2, gelatin, methacrylic acid copolymer, stearic acid and titanium dioxide. The imprinting ink contains ferric oxide black, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
</NDCList>