{
"NDC": [
{
"NDCCode": "68180-319-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-06) ",
"NDC11Code": "68180-0319-06",
"ProductNDC": "68180-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090693",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170614",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablet (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20."
},
{
"NDCCode": "68180-319-02",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-02) ",
"NDC11Code": "68180-0319-02",
"ProductNDC": "68180-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090693",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170614",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablet (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20."
},
{
"NDCCode": "68180-319-09",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-319-09) ",
"NDC11Code": "68180-0319-09",
"ProductNDC": "68180-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090693",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170614",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablet (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20."
},
{
"NDCCode": "11697-319-06",
"PackageDescription": "178 mL in 1 BOTTLE, SPRAY (11697-319-06)",
"NDC11Code": "11697-0319-06",
"ProductNDC": "11697-319",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Sunscreen",
"NonProprietaryName": "Homosalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100816",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Aloe Vera of America, Inc.",
"SubstanceName": "AVOBENZONE; ENSULIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "5.34; 7.12; 17.8; 8.9; 4.9662",
"StrengthUnit": "mL/178mL; mL/178mL; mL/178mL; mL/178mL; mL/178mL",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "51991-319-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (51991-319-06)",
"NDC11Code": "51991-0319-06",
"ProductNDC": "51991-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201003",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
},
{
"NDCCode": "55289-319-06",
"PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (55289-319-06) ",
"NDC11Code": "55289-0319-06",
"ProductNDC": "55289-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077824",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20091231",
"SamplePackage": "N"
},
{
"NDCCode": "68428-319-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-319-06) ",
"NDC11Code": "68428-0319-06",
"ProductNDC": "68428-319",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cina",
"NonProprietaryName": "Artemisia Cina Pre-flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARTEMISIA CINA PRE-FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. CINA Worms."
},
{
"NDCCode": "72789-319-06",
"PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-319-06) ",
"NDC11Code": "72789-0319-06",
"ProductNDC": "72789-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19860710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062677",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, FD&C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: lactose monohydrate, carnauba wax, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "74454-319-06",
"PackageDescription": "100 mL in 1 BOTTLE, PUMP (74454-319-06) ",
"NDC11Code": "74454-0319-06",
"ProductNDC": "74454-319",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "M.meiday M.kill Hand Sanitizer Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200410",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FEEL COSMETIC KOREA CO., LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200410",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "83013-319-06",
"PackageDescription": "60 g in 1 BOTTLE, PUMP (83013-319-06) ",
"NDC11Code": "83013-0319-06",
"ProductNDC": "83013-319",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hismile",
"NonProprietaryName": "Banana Flavor Sodium Fluoride Anticavity Toothpaste",
"DosageFormName": "GEL",
"RouteName": "DENTAL",
"StartMarketingDate": "20240114",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Hismile Pty Ltd",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240114",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "68180-130-06",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68180-130-06) ",
"NDC11Code": "68180-0130-06",
"ProductNDC": "68180-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021695",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "43",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130222",
"SamplePackage": "N",
"IndicationAndUsage": "Antara is indicated as adjunctive therapy to diet: To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].",
"Description": "Antara (fenofibrate) Capsule, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, l-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79°C to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: Each gelatin capsule contains sugar spheres, hypromellose, sodium lauryl sulfate, dimethicone, simethicone, and talc. The gelatin capsules also contain black iron oxide, D&C Yellow #10, Indigo carmine FD&C Blue #2, shellac, soya lecithin, sulfur dioxide, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "68180-131-06",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68180-131-06) ",
"NDC11Code": "68180-0131-06",
"ProductNDC": "68180-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021695",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "130",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130222",
"SamplePackage": "N",
"IndicationAndUsage": "Antara is indicated as adjunctive therapy to diet: To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].",
"Description": "Antara (fenofibrate) Capsule, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, l-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79°C to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: Each gelatin capsule contains sugar spheres, hypromellose, sodium lauryl sulfate, dimethicone, simethicone, and talc. The gelatin capsules also contain black iron oxide, D&C Yellow #10, Indigo carmine FD&C Blue #2, shellac, soya lecithin, sulfur dioxide, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "68180-137-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68180-137-06) ",
"NDC11Code": "68180-0137-06",
"ProductNDC": "68180-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitslopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078169",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120910",
"SamplePackage": "N"
},
{
"NDCCode": "68180-151-06",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-06) ",
"NDC11Code": "68180-0151-06",
"ProductNDC": "68180-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirabegron",
"NonProprietaryName": "Mirabegron",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209485",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MIRABEGRON",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240419",
"SamplePackage": "N",
"IndicationAndUsage": "Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: 1 Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1.1).",
"Description": "Mirabegron extended-release tablet for oral use is a beta-3 adrenergic agonist. The chemical name of mirabegron is 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{([(2R)-2-hydroxy-2-phenylethyl] amino}ethyl)phenyl] acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural formula of mirabegron is. Mirabegron is an off-white to light yellow colored powder. It is practically insoluble in water. It is soluble in methanol and dimethyl sulfoxide. Each mirabegron extended-release tablet for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: butylated hydroxytoluene, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6, hydroxy propyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, titanium dioxide, triacetin."
},
{
"NDCCode": "68180-152-06",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-152-06) ",
"NDC11Code": "68180-0152-06",
"ProductNDC": "68180-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirabegron",
"NonProprietaryName": "Mirabegron",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209485",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MIRABEGRON",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: 1 Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1.1).",
"Description": "Mirabegron extended-release tablet for oral use is a beta-3 adrenergic agonist. The chemical name of mirabegron is 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{([(2R)-2-hydroxy-2-phenylethyl] amino}ethyl)phenyl] acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural formula of mirabegron is. Mirabegron is an off-white to light yellow colored powder. It is practically insoluble in water. It is soluble in methanol and dimethyl sulfoxide. Each mirabegron extended-release tablet for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: butylated hydroxytoluene, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6, hydroxy propyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, titanium dioxide, triacetin."
},
{
"NDCCode": "68180-153-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68180-153-06) ",
"NDC11Code": "68180-0153-06",
"ProductNDC": "68180-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desloratadine",
"NonProprietaryName": "Desloratadine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078352",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DESLORATADINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130225",
"SamplePackage": "N"
},
{
"NDCCode": "68180-157-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (68180-157-06) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "68180-0157-06",
"ProductNDC": "68180-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobazam",
"NonProprietaryName": "Clobazam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210545",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "CLOBAZAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190508",
"SamplePackage": "N"
},
{
"NDCCode": "68180-158-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (68180-158-06) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "68180-0158-06",
"ProductNDC": "68180-158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobazam",
"NonProprietaryName": "Clobazam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210545",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "CLOBAZAM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190508",
"SamplePackage": "N"
},
{
"NDCCode": "68180-160-06",
"PackageDescription": "30 TABLET in 1 CONTAINER (68180-160-06) ",
"NDC11Code": "68180-0160-06",
"ProductNDC": "68180-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Monohydrate",
"NonProprietaryName": "Azithromycin Monohydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150818",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065398",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150818",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin is supplied as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide, triacetin and D&C Red #30. Organic Impurities Test Pending."
},
{
"NDCCode": "68180-161-06",
"PackageDescription": "30 TABLET in 1 CONTAINER (68180-161-06) ",
"NDC11Code": "68180-0161-06",
"ProductNDC": "68180-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Monohydrate",
"NonProprietaryName": "Azithromycin Monohydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150818",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065399",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150818",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin is supplied as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide, triacetin and D&C Red #30. Organic Impurities Test Pending."
},
{
"NDCCode": "68180-162-06",
"PackageDescription": "30 TABLET in 1 CONTAINER (68180-162-06) ",
"NDC11Code": "68180-0162-06",
"ProductNDC": "68180-162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Monohydrate",
"NonProprietaryName": "Azithromycin Monohydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150818",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065400",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150818",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria. : 1 Mycobacterial Infections (1.2).",
"Description": "Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.0. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.0. Azithromycin tablets USP contain azithromycin monohydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. Organic Impurities Test Pending."
},
{
"NDCCode": "68180-185-06",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68180-185-06) ",
"NDC11Code": "68180-0185-06",
"ProductNDC": "68180-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mefenamic Acid",
"NonProprietaryName": "Mefenamic Acid",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091322",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MEFENAMIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110906",
"SamplePackage": "N",
"IndicationAndUsage": "Mefenamic acid capsules are nonsteroidal anti-inflammatory drug indicated for: 1 For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). (1.1), 2 For treatment of primary dysmenorrhea. (1.2).",
"Description": "Mefenamic acid capsules USP contains active moiety mefenamic acid, which is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name of mefenamic acid is N-2,3-xylylanthranilic acid. The molecular weight is 241.29 g/mol. Its molecular formula is C15H15N02 and the structural formula of mefenamic acid is. Mefenamic acid is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230° to 231°C and water solubility of 0.004 % at pH 7.1. Mefenamic acid capsules are for oral administration. Each capsule contains 250 mg of mefenamic acid, lactose monohydrate and magnesium stearate. The capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, D&C yellow No. 10, FD&C yellow No. 6 and FD&C red No. 3."
},
{
"NDCCode": "68180-188-06",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68180-188-06) ",
"NDC11Code": "68180-0188-06",
"ProductNDC": "68180-188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209487",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201222",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam capsules are indicated for management of osteoarthritis pain.",
"Description": "Meloxicam Capsules are a nonsteroidal anti-inflammatory drug, available as yellow and green capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.40. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has a partition coefficient (Log P) = 2.662 ± 0.848 at 25°C. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in meloxicam capsules include: crospovidone, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The capsule shells contain D & C Yellow No. 10, FD & C Blue No. 1, FD & C Red No. 40 (for 10 mg strength only), FD & C Yellow No. 6 (for 5 mg strength only), gelatin and titanium dioxide. The imprinting on the gelatin capsules is black edible ink which contains black iron oxide, potassium hydroxide, propylene glycol, shellac and titanium dioxide. The 5 mg capsules have a yellow opaque cap and yellow opaque body, imprinted with \"LU\" on cap and \"M76\" on body in black ink. The 10 mg capsules have a green opaque cap and green opaque body, imprinted with \"LU\" on cap and \"M78\" on body in black ink."
},
{
"NDCCode": "68180-189-06",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68180-189-06) ",
"NDC11Code": "68180-0189-06",
"ProductNDC": "68180-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209487",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201222",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam capsules are indicated for management of osteoarthritis pain.",
"Description": "Meloxicam Capsules are a nonsteroidal anti-inflammatory drug, available as yellow and green capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.40. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has a partition coefficient (Log P) = 2.662 ± 0.848 at 25°C. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in meloxicam capsules include: crospovidone, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The capsule shells contain D & C Yellow No. 10, FD & C Blue No. 1, FD & C Red No. 40 (for 10 mg strength only), FD & C Yellow No. 6 (for 5 mg strength only), gelatin and titanium dioxide. The imprinting on the gelatin capsules is black edible ink which contains black iron oxide, potassium hydroxide, propylene glycol, shellac and titanium dioxide. The 5 mg capsules have a yellow opaque cap and yellow opaque body, imprinted with \"LU\" on cap and \"M76\" on body in black ink. The 10 mg capsules have a green opaque cap and green opaque body, imprinted with \"LU\" on cap and \"M78\" on body in black ink."
},
{
"NDCCode": "68180-193-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68180-193-06) ",
"NDC11Code": "68180-0193-06",
"ProductNDC": "68180-193",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Hydrochlorothiazide",
"NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091351",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE; TELMISARTAN",
"StrengthNumber": "12.5; 40",
"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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150428",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1). Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1).",
"Description": "Telmisartan and hydrochlorothiazide tablets USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1, 4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: crosscarmalose sodium, lactose monohydrate, magnesium stearate, povidone and sodium hydroxide. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain red iron oxide, and the 80 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "68180-194-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68180-194-06) ",
"NDC11Code": "68180-0194-06",
"ProductNDC": "68180-194",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Hydrochlorothiazide",
"NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091351",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE; TELMISARTAN",
"StrengthNumber": "12.5; 80",
"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": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150428",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1). Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1).",
"Description": "Telmisartan and hydrochlorothiazide tablets USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1, 4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: crosscarmalose sodium, lactose monohydrate, magnesium stearate, povidone and sodium hydroxide. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain red iron oxide, and the 80 mg/25 mg tablets contain yellow iron oxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Lupin Pharmaceuticals, Inc.",
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"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1). Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1).",
"Description": "Telmisartan and hydrochlorothiazide tablets USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1, 4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: crosscarmalose sodium, lactose monohydrate, magnesium stearate, povidone and sodium hydroxide. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain red iron oxide, and the 80 mg/25 mg tablets contain yellow iron oxide."
},
{
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"PackageDescription": "30 TABLET in 1 BOTTLE (68180-196-06) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Telmisartan And Amlodipine",
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"LabelerName": "Lupin Pharmaceuticals, Inc.",
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"StrengthUnit": "mg/1; mg/1",
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"SamplePackage": "N"
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{
"NDCCode": "68180-197-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68180-197-06) ",
"NDC11Code": "68180-0197-06",
"ProductNDC": "68180-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Amlodipine",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; TELMISARTAN",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140108",
"SamplePackage": "N"
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{
"NDCCode": "68180-198-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68180-198-06) ",
"NDC11Code": "68180-0198-06",
"ProductNDC": "68180-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Amlodipine",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"ApplicationNumber": "ANDA201586",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; TELMISARTAN",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
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<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20.</Description>
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<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20.</Description>
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<NDC>
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<LastUpdate>2026-07-17</LastUpdate>
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<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
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<ProprietaryName>Ranitidine</ProprietaryName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2019-09-21</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cina</ProprietaryName>
<NonProprietaryName>Artemisia Cina Pre-flowering Top</NonProprietaryName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARTEMISIA CINA PRE-FLOWERING TOP</SubstanceName>
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<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. CINA Worms.</IndicationAndUsage>
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<NDCCode>72789-319-06</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
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<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, FD&C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: lactose monohydrate, carnauba wax, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
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<ProductNDC>74454-319</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200410</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>FEEL COSMETIC KOREA CO., LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83013-319-06</NDCCode>
<PackageDescription>60 g in 1 BOTTLE, PUMP (83013-319-06) </PackageDescription>
<NDC11Code>83013-0319-06</NDC11Code>
<ProductNDC>83013-319</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hismile</ProprietaryName>
<NonProprietaryName>Banana Flavor Sodium Fluoride Anticavity Toothpaste</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20240114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Hismile Pty Ltd</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68180-130-06</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68180-130-06) </PackageDescription>
<NDC11Code>68180-0130-06</NDC11Code>
<ProductNDC>68180-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021695</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>43</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antara is indicated as adjunctive therapy to diet: To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Antara (fenofibrate) Capsule, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, l-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79°C to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: Each gelatin capsule contains sugar spheres, hypromellose, sodium lauryl sulfate, dimethicone, simethicone, and talc. The gelatin capsules also contain black iron oxide, D&C Yellow #10, Indigo carmine FD&C Blue #2, shellac, soya lecithin, sulfur dioxide, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68180-131-06</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68180-131-06) </PackageDescription>
<NDC11Code>68180-0131-06</NDC11Code>
<ProductNDC>68180-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021695</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antara is indicated as adjunctive therapy to diet: To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Antara (fenofibrate) Capsule, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, l-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79°C to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: Each gelatin capsule contains sugar spheres, hypromellose, sodium lauryl sulfate, dimethicone, simethicone, and talc. The gelatin capsules also contain black iron oxide, D&C Yellow #10, Indigo carmine FD&C Blue #2, shellac, soya lecithin, sulfur dioxide, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68180-137-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-137-06) </PackageDescription>
<NDC11Code>68180-0137-06</NDC11Code>
<ProductNDC>68180-137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitslopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078169</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-151-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-06) </PackageDescription>
<NDC11Code>68180-0151-06</NDC11Code>
<ProductNDC>68180-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirabegron</ProprietaryName>
<NonProprietaryName>Mirabegron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209485</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MIRABEGRON</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: 1 Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1.1).</IndicationAndUsage>
<Description>Mirabegron extended-release tablet for oral use is a beta-3 adrenergic agonist. The chemical name of mirabegron is 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{([(2R)-2-hydroxy-2-phenylethyl] amino}ethyl)phenyl] acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural formula of mirabegron is. Mirabegron is an off-white to light yellow colored powder. It is practically insoluble in water. It is soluble in methanol and dimethyl sulfoxide. Each mirabegron extended-release tablet for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: butylated hydroxytoluene, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6, hydroxy propyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>68180-152-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-152-06) </PackageDescription>
<NDC11Code>68180-0152-06</NDC11Code>
<ProductNDC>68180-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirabegron</ProprietaryName>
<NonProprietaryName>Mirabegron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209485</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MIRABEGRON</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: 1 Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1.1).</IndicationAndUsage>
<Description>Mirabegron extended-release tablet for oral use is a beta-3 adrenergic agonist. The chemical name of mirabegron is 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{([(2R)-2-hydroxy-2-phenylethyl] amino}ethyl)phenyl] acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural formula of mirabegron is. Mirabegron is an off-white to light yellow colored powder. It is practically insoluble in water. It is soluble in methanol and dimethyl sulfoxide. Each mirabegron extended-release tablet for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: butylated hydroxytoluene, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6, hydroxy propyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>68180-153-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68180-153-06) </PackageDescription>
<NDC11Code>68180-0153-06</NDC11Code>
<ProductNDC>68180-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desloratadine</ProprietaryName>
<NonProprietaryName>Desloratadine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078352</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DESLORATADINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-157-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68180-157-06) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68180-0157-06</NDC11Code>
<ProductNDC>68180-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobazam</ProprietaryName>
<NonProprietaryName>Clobazam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210545</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLOBAZAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-158-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68180-158-06) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68180-0158-06</NDC11Code>
<ProductNDC>68180-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobazam</ProprietaryName>
<NonProprietaryName>Clobazam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210545</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLOBAZAM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-160-06</NDCCode>
<PackageDescription>30 TABLET in 1 CONTAINER (68180-160-06) </PackageDescription>
<NDC11Code>68180-0160-06</NDC11Code>
<ProductNDC>68180-160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Monohydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150818</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065398</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150818</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin is supplied as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide, triacetin and D&C Red #30. Organic Impurities Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>68180-161-06</NDCCode>
<PackageDescription>30 TABLET in 1 CONTAINER (68180-161-06) </PackageDescription>
<NDC11Code>68180-0161-06</NDC11Code>
<ProductNDC>68180-161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Monohydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150818</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065399</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150818</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin is supplied as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide, triacetin and D&C Red #30. Organic Impurities Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>68180-162-06</NDCCode>
<PackageDescription>30 TABLET in 1 CONTAINER (68180-162-06) </PackageDescription>
<NDC11Code>68180-0162-06</NDC11Code>
<ProductNDC>68180-162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Monohydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150818</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065400</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150818</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria. : 1 Mycobacterial Infections (1.2).</IndicationAndUsage>
<Description>Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.0. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.0. Azithromycin tablets USP contain azithromycin monohydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. Organic Impurities Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>68180-185-06</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68180-185-06) </PackageDescription>
<NDC11Code>68180-0185-06</NDC11Code>
<ProductNDC>68180-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mefenamic Acid</ProprietaryName>
<NonProprietaryName>Mefenamic Acid</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091322</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MEFENAMIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mefenamic acid capsules are nonsteroidal anti-inflammatory drug indicated for: 1 For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). (1.1), 2 For treatment of primary dysmenorrhea. (1.2).</IndicationAndUsage>
<Description>Mefenamic acid capsules USP contains active moiety mefenamic acid, which is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name of mefenamic acid is N-2,3-xylylanthranilic acid. The molecular weight is 241.29 g/mol. Its molecular formula is C15H15N02 and the structural formula of mefenamic acid is. Mefenamic acid is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230° to 231°C and water solubility of 0.004 % at pH 7.1. Mefenamic acid capsules are for oral administration. Each capsule contains 250 mg of mefenamic acid, lactose monohydrate and magnesium stearate. The capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, D&C yellow No. 10, FD&C yellow No. 6 and FD&C red No. 3.</Description>
</NDC>
<NDC>
<NDCCode>68180-188-06</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68180-188-06) </PackageDescription>
<NDC11Code>68180-0188-06</NDC11Code>
<ProductNDC>68180-188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209487</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam capsules are indicated for management of osteoarthritis pain.</IndicationAndUsage>
<Description>Meloxicam Capsules are a nonsteroidal anti-inflammatory drug, available as yellow and green capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.40. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has a partition coefficient (Log P) = 2.662 ± 0.848 at 25°C. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in meloxicam capsules include: crospovidone, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The capsule shells contain D & C Yellow No. 10, FD & C Blue No. 1, FD & C Red No. 40 (for 10 mg strength only), FD & C Yellow No. 6 (for 5 mg strength only), gelatin and titanium dioxide. The imprinting on the gelatin capsules is black edible ink which contains black iron oxide, potassium hydroxide, propylene glycol, shellac and titanium dioxide. The 5 mg capsules have a yellow opaque cap and yellow opaque body, imprinted with "LU" on cap and "M76" on body in black ink. The 10 mg capsules have a green opaque cap and green opaque body, imprinted with "LU" on cap and "M78" on body in black ink.</Description>
</NDC>
<NDC>
<NDCCode>68180-189-06</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68180-189-06) </PackageDescription>
<NDC11Code>68180-0189-06</NDC11Code>
<ProductNDC>68180-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209487</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam capsules are indicated for management of osteoarthritis pain.</IndicationAndUsage>
<Description>Meloxicam Capsules are a nonsteroidal anti-inflammatory drug, available as yellow and green capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.40. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has a partition coefficient (Log P) = 2.662 ± 0.848 at 25°C. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in meloxicam capsules include: crospovidone, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The capsule shells contain D & C Yellow No. 10, FD & C Blue No. 1, FD & C Red No. 40 (for 10 mg strength only), FD & C Yellow No. 6 (for 5 mg strength only), gelatin and titanium dioxide. The imprinting on the gelatin capsules is black edible ink which contains black iron oxide, potassium hydroxide, propylene glycol, shellac and titanium dioxide. The 5 mg capsules have a yellow opaque cap and yellow opaque body, imprinted with "LU" on cap and "M76" on body in black ink. The 10 mg capsules have a green opaque cap and green opaque body, imprinted with "LU" on cap and "M78" on body in black ink.</Description>
</NDC>
<NDC>
<NDCCode>68180-193-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-193-06) </PackageDescription>
<NDC11Code>68180-0193-06</NDC11Code>
<ProductNDC>68180-193</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091351</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; TELMISARTAN</SubstanceName>
<StrengthNumber>12.5; 40</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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1). Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1).</IndicationAndUsage>
<Description>Telmisartan and hydrochlorothiazide tablets USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1, 4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: crosscarmalose sodium, lactose monohydrate, magnesium stearate, povidone and sodium hydroxide. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain red iron oxide, and the 80 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68180-194-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-194-06) </PackageDescription>
<NDC11Code>68180-0194-06</NDC11Code>
<ProductNDC>68180-194</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091351</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; TELMISARTAN</SubstanceName>
<StrengthNumber>12.5; 80</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>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1). Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1).</IndicationAndUsage>
<Description>Telmisartan and hydrochlorothiazide tablets USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1, 4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: crosscarmalose sodium, lactose monohydrate, magnesium stearate, povidone and sodium hydroxide. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain red iron oxide, and the 80 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68180-195-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-195-06) </PackageDescription>
<NDC11Code>68180-0195-06</NDC11Code>
<ProductNDC>68180-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091351</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; TELMISARTAN</SubstanceName>
<StrengthNumber>25; 80</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>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1). Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1).</IndicationAndUsage>
<Description>Telmisartan and hydrochlorothiazide tablets USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1, 4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: crosscarmalose sodium, lactose monohydrate, magnesium stearate, povidone and sodium hydroxide. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain red iron oxide, and the 80 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68180-196-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-196-06) </PackageDescription>
<NDC11Code>68180-0196-06</NDC11Code>
<ProductNDC>68180-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Amlodipine</ProprietaryName>
<NonProprietaryName>Telmisartan And Amlodipine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201586</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; TELMISARTAN</SubstanceName>
<StrengthNumber>5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-197-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-197-06) </PackageDescription>
<NDC11Code>68180-0197-06</NDC11Code>
<ProductNDC>68180-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Amlodipine</ProprietaryName>
<NonProprietaryName>Telmisartan And Amlodipine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201586</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; TELMISARTAN</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-198-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-198-06) </PackageDescription>
<NDC11Code>68180-0198-06</NDC11Code>
<ProductNDC>68180-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Amlodipine</ProprietaryName>
<NonProprietaryName>Telmisartan And Amlodipine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201586</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; TELMISARTAN</SubstanceName>
<StrengthNumber>5; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>