{
"NDC": [
{
"NDCCode": "0597-0135-54",
"PackageDescription": "1 BOTTLE in 1 CARTON (0597-0135-54) > 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "00597-0135-54",
"ProductNDC": "0597-0135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101026",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022512",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101026",
"EndMarketingDatePackage": "20200430",
"SamplePackage": "N"
},
{
"NDCCode": "0597-0135-12",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0597-0135-12) > 6 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00597-0135-12",
"ProductNDC": "0597-0135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101026",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022512",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101026",
"EndMarketingDatePackage": "20200430",
"SamplePackage": "N"
},
{
"NDCCode": "0597-0135-60",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0597-0135-60) > 6 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00597-0135-60",
"ProductNDC": "0597-0135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101026",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022512",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101026",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "0597-0108-54",
"PackageDescription": "1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "00597-0108-54",
"ProductNDC": "0597-0108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151123",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022512",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170707",
"SamplePackage": "N",
"IndicationAndUsage": "PRADAXA Capsules is a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid. The capsule shell is composed of black edible ink, carrageenan, FD&C Blue No. 2 (150 mg and 110 mg capsules only), hypromellose, potassium chloride, and titanium dioxide."
},
{
"NDCCode": "0597-0122-54",
"PackageDescription": "1 BOTTLE in 1 CARTON (0597-0122-54) > 60 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "00597-0122-54",
"ProductNDC": "0597-0122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zantac 75",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061221",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020520",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals Inc.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-05-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20061221",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "0597-0149-54",
"PackageDescription": "1 BOTTLE in 1 CARTON (0597-0149-54) > 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "00597-0149-54",
"ProductNDC": "0597-0149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110808",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022512",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110808",
"SamplePackage": "N"
},
{
"NDCCode": "0597-0340-54",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0597-0340-54) > 25 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "00597-0340-54",
"ProductNDC": "0597-0340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dulcolax",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130801",
"SamplePackage": "N"
},
{
"NDCCode": "0135-0537-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0135-0537-02) > 54.7 mL in 1 BOTTLE",
"NDC11Code": "00135-0537-02",
"ProductNDC": "0135-0537",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panadol",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121015",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "GlaxoSmithKline Consumer Healthcare LP",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-08-15"
},
{
"NDCCode": "0135-0539-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0135-0539-02) / 54.7 mL in 1 BOTTLE",
"NDC11Code": "00135-0539-02",
"ProductNDC": "0135-0539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panadol",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121015",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121015",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: coldsfluheadachetoothache. temporarily reduces fever."
},
{
"NDCCode": "0135-0606-05",
"PackageDescription": "2 BOTTLE in 1 PACKAGE (0135-0606-05) / 54 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "00135-0606-05",
"ProductNDC": "0135-0606",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tums Chewy Bites",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210302",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "0135-0624-02",
"PackageDescription": "54 TABLET, CHEWABLE in 1 BOTTLE (0135-0624-02) ",
"NDC11Code": "00135-0624-02",
"ProductNDC": "0135-0624",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tums Chewy Bites With Gas Relief",
"NonProprietaryName": "Calcium Carbonate And Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CALCIUM CARBONATE; DIMETHICONE, UNSPECIFIED",
"StrengthNumber": "750; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms, 5 gas associated with heartburn, sour stomach, or acid indigestion."
},
{
"NDCCode": "0135-0641-03",
"PackageDescription": "3 BOTTLE in 1 PACKAGE (0135-0641-03) / 54 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "00135-0641-03",
"ProductNDC": "0135-0641",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tums Chewy Bites",
"ProprietaryNameSuffix": "Mixed Fruit",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210115",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "21749-135-54",
"PackageDescription": "208000 mL in 1 PACKAGE (21749-135-54) ",
"NDC11Code": "21749-0135-54",
"ProductNDC": "21749-135",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gojo E2 Sanitizing Ltn Sp",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040917",
"EndMarketingDate": "20220530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".003",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040917",
"EndMarketingDatePackage": "20220530",
"SamplePackage": "N"
},
{
"NDCCode": "41250-135-54",
"PackageDescription": "54 TABLET, CHEWABLE in 1 BOTTLE (41250-135-54) ",
"NDC11Code": "41250-0135-54",
"ProductNDC": "41250-135",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid And Anti-gas Chew",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20170405",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Meijer",
"SubstanceName": "CALCIUM CARBONATE; DIMETHICONE",
"StrengthNumber": "750; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170405",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Relieves. Heartburn. Sour stomach. Acid indigestion. Upset stomach associated with these symptoms. Bloating, pressure or stuffed feeling commonly referred to as gas."
},
{
"NDCCode": "0597-0140-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30) ",
"NDC11Code": "00597-0140-30",
"ProductNDC": "0597-0140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tradjenta",
"NonProprietaryName": "Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201280",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110509",
"SamplePackage": "N",
"IndicationAndUsage": "TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: copovidone, corn starch, magnesium stearate, mannitol, and pregelatinized starch. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, red ferric oxide, talc, and titanium dioxide."
},
{
"NDCCode": "0597-0140-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00597-0140-61",
"ProductNDC": "0597-0140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tradjenta",
"NonProprietaryName": "Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201280",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110509",
"SamplePackage": "N",
"IndicationAndUsage": "TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: copovidone, corn starch, magnesium stearate, mannitol, and pregelatinized starch. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, red ferric oxide, talc, and titanium dioxide."
},
{
"NDCCode": "0597-0140-70",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (0597-0140-70) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00597-0140-70",
"ProductNDC": "0597-0140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tradjenta",
"NonProprietaryName": "Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201280",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110509",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "Y",
"IndicationAndUsage": "TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: copovidone, corn starch, magnesium stearate, mannitol, and pregelatinized starch. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, red ferric oxide, talc, and titanium dioxide."
},
{
"NDCCode": "0597-0140-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90) ",
"NDC11Code": "00597-0140-90",
"ProductNDC": "0597-0140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tradjenta",
"NonProprietaryName": "Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201280",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110509",
"SamplePackage": "N",
"IndicationAndUsage": "TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: copovidone, corn starch, magnesium stearate, mannitol, and pregelatinized starch. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, red ferric oxide, talc, and titanium dioxide."
},
{
"NDCCode": "0597-0146-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (0597-0146-18) ",
"NDC11Code": "00597-0146-18",
"ProductNDC": "0597-0146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201281",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120213",
"SamplePackage": "N",
"IndicationAndUsage": "JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0146-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0597-0146-60) ",
"NDC11Code": "00597-0146-60",
"ProductNDC": "0597-0146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201281",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120213",
"SamplePackage": "N",
"IndicationAndUsage": "JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0147-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (0597-0147-18) ",
"NDC11Code": "00597-0147-18",
"ProductNDC": "0597-0147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201281",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 850",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120213",
"SamplePackage": "N",
"IndicationAndUsage": "JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0147-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0597-0147-60) ",
"NDC11Code": "00597-0147-60",
"ProductNDC": "0597-0147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201281",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 850",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120213",
"SamplePackage": "N",
"IndicationAndUsage": "JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0148-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (0597-0148-18) ",
"NDC11Code": "00597-0148-18",
"ProductNDC": "0597-0148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201281",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20120213",
"SamplePackage": "N",
"IndicationAndUsage": "JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0148-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0597-0148-60) ",
"NDC11Code": "00597-0148-60",
"ProductNDC": "0597-0148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201281",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20120213",
"SamplePackage": "N",
"IndicationAndUsage": "JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0270-73",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73) ",
"NDC11Code": "00597-0270-73",
"ProductNDC": "0597-0270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto Xr",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208026",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160527",
"SamplePackage": "N",
"IndicationAndUsage": "JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 1 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin), 2 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0270-94",
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"NDC11Code": "00597-0270-94",
"ProductNDC": "0597-0270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto Xr",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208026",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "2.5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
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"IndicationAndUsage": "JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 1 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin), 2 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0275-33",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33) ",
"NDC11Code": "00597-0275-33",
"ProductNDC": "0597-0275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto Xr",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208026",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
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"IndicationAndUsage": "JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 1 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin), 2 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "0597-0275-81",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-81) ",
"NDC11Code": "00597-0275-81",
"ProductNDC": "0597-0275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jentadueto Xr",
"NonProprietaryName": "Linagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208026",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].",
"Description": "JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 1 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin), 2 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)."
},
{
"NDCCode": "68083-597-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-597-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-597-01) ",
"NDC11Code": "68083-0597-10",
"ProductNDC": "68083-597",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218140",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-05-16",
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"StartMarketingDatePackage": "20250321",
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"IndicationAndUsage": "Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
"Description": "Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)- (3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxohexo-pyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro- 2,3,4,5,6,7,23,24,25, 26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2 (methylamino) valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano) 13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadia- zacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 769 mg, 1.28 g, or 1.54 g of vancomycin hydrochloride, USP equivalent to 750 mg, 1.25 g, or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)]."
},
{
"NDCCode": "68180-135-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (68180-135-01) ",
"NDC11Code": "68180-0135-01",
"ProductNDC": "68180-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitslopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078169",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram tablets are indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older., 2 generalized anxiety disorder (GAD) in adults.",
"Description": "Escitalopram tablets USP contains escitalopram a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP, for oral use, are film-coated, round tablets containing 6.385 mg, 12.77 mg, 25.54 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. Inactive ingredients for 5 mg, 10 mg and 20 mg strengths include croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicified microcrystalline cellulose, talc and titanium dioxide. Escitalopram tablets USP meets USP Dissolution Test 2."
}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRADAXA Capsules is a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid. The capsule shell is composed of black edible ink, carrageenan, FD&C Blue No. 2 (150 mg and 110 mg capsules only), hypromellose, potassium chloride, and titanium dioxide.</Description>
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<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (0597-0122-54) > 60 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00597-0122-54</NDC11Code>
<ProductNDC>0597-0122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zantac 75</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061221</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020520</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20061221</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<StartMarketingDate>20110808</StartMarketingDate>
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<ApplicationNumber>NDA022512</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<NDCCode>0597-0340-54</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0597-0340-54) > 25 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00597-0340-54</NDC11Code>
<ProductNDC>0597-0340</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dulcolax</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0135-0537-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0135-0537-02) > 54.7 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0537-02</NDC11Code>
<ProductNDC>0135-0537</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panadol</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare LP</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-08-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0135-0539-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0135-0539-02) / 54.7 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0539-02</NDC11Code>
<ProductNDC>0135-0539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panadol</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: coldsfluheadachetoothache. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0606-05</NDCCode>
<PackageDescription>2 BOTTLE in 1 PACKAGE (0135-0606-05) / 54 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0606-05</NDC11Code>
<ProductNDC>0135-0606</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tums Chewy Bites</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0624-02</NDCCode>
<PackageDescription>54 TABLET, CHEWABLE in 1 BOTTLE (0135-0624-02) </PackageDescription>
<NDC11Code>00135-0624-02</NDC11Code>
<ProductNDC>0135-0624</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tums Chewy Bites With Gas Relief</ProprietaryName>
<NonProprietaryName>Calcium Carbonate And Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE; DIMETHICONE, UNSPECIFIED</SubstanceName>
<StrengthNumber>750; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms, 5 gas associated with heartburn, sour stomach, or acid indigestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0641-03</NDCCode>
<PackageDescription>3 BOTTLE in 1 PACKAGE (0135-0641-03) / 54 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0641-03</NDC11Code>
<ProductNDC>0135-0641</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tums Chewy Bites</ProprietaryName>
<ProprietaryNameSuffix>Mixed Fruit</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21749-135-54</NDCCode>
<PackageDescription>208000 mL in 1 PACKAGE (21749-135-54) </PackageDescription>
<NDC11Code>21749-0135-54</NDC11Code>
<ProductNDC>21749-135</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gojo E2 Sanitizing Ltn Sp</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040917</StartMarketingDate>
<EndMarketingDate>20220530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.003</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040917</StartMarketingDatePackage>
<EndMarketingDatePackage>20220530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41250-135-54</NDCCode>
<PackageDescription>54 TABLET, CHEWABLE in 1 BOTTLE (41250-135-54) </PackageDescription>
<NDC11Code>41250-0135-54</NDC11Code>
<ProductNDC>41250-135</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antacid And Anti-gas Chew</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Meijer</LabelerName>
<SubstanceName>CALCIUM CARBONATE; DIMETHICONE</SubstanceName>
<StrengthNumber>750; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Relieves. Heartburn. Sour stomach. Acid indigestion. Upset stomach associated with these symptoms. Bloating, pressure or stuffed feeling commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0597-0140-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30) </PackageDescription>
<NDC11Code>00597-0140-30</NDC11Code>
<ProductNDC>0597-0140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tradjenta</ProprietaryName>
<NonProprietaryName>Linagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201280</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINAGLIPTIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: copovidone, corn starch, magnesium stearate, mannitol, and pregelatinized starch. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, red ferric oxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0597-0140-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00597-0140-61</NDC11Code>
<ProductNDC>0597-0140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tradjenta</ProprietaryName>
<NonProprietaryName>Linagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201280</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINAGLIPTIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: copovidone, corn starch, magnesium stearate, mannitol, and pregelatinized starch. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, red ferric oxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0597-0140-70</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 CARTON (0597-0140-70) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00597-0140-70</NDC11Code>
<ProductNDC>0597-0140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tradjenta</ProprietaryName>
<NonProprietaryName>Linagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201280</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINAGLIPTIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110509</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: copovidone, corn starch, magnesium stearate, mannitol, and pregelatinized starch. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, red ferric oxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0597-0140-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90) </PackageDescription>
<NDC11Code>00597-0140-90</NDC11Code>
<ProductNDC>0597-0140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tradjenta</ProprietaryName>
<NonProprietaryName>Linagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201280</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINAGLIPTIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: copovidone, corn starch, magnesium stearate, mannitol, and pregelatinized starch. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, red ferric oxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0597-0146-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (0597-0146-18) </PackageDescription>
<NDC11Code>00597-0146-18</NDC11Code>
<ProductNDC>0597-0146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jentadueto</ProprietaryName>
<NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201281</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
</NDC>
<NDC>
<NDCCode>0597-0146-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0597-0146-60) </PackageDescription>
<NDC11Code>00597-0146-60</NDC11Code>
<ProductNDC>0597-0146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<IndicationAndUsage>JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
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<Description>JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
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<Description>JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
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<Description>JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
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<IndicationAndUsage>JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JENTADUETO tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO. JENTADUETO is available for oral administration as tablets containing: 1 2.5 mg linagliptin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin), 2 2.5 mg linagliptin and 850 mg metformin HCl (equivalent 662.88 mg of metformin), 3 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
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<IndicationAndUsage>JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 1 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin), 2 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
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<IndicationAndUsage>JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 1 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin), 2 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 1 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin), 2 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
</NDC>
<NDC>
<NDCCode>0597-0275-81</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-81) </PackageDescription>
<NDC11Code>00597-0275-81</NDC11Code>
<ProductNDC>0597-0275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jentadueto Xr</ProprietaryName>
<NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160527</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208026</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin. Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Metformin HCl. Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 1 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin), 2 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin).</Description>
</NDC>
<NDC>
<NDCCode>68083-597-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (68083-597-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-597-01) </PackageDescription>
<NDC11Code>68083-0597-10</NDC11Code>
<ProductNDC>68083-597</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218140</ApplicationNumber>
<LabelerName>Gland Pharma Limited</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)- (3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxohexo-pyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro- 2,3,4,5,6,7,23,24,25, 26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2 (methylamino) valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano) 13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadia- zacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 769 mg, 1.28 g, or 1.54 g of vancomycin hydrochloride, USP equivalent to 750 mg, 1.25 g, or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
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<NDC>
<NDCCode>68180-135-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68180-135-01) </PackageDescription>
<NDC11Code>68180-0135-01</NDC11Code>
<ProductNDC>68180-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitslopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078169</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120910</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram tablets are indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older., 2 generalized anxiety disorder (GAD) in adults.</IndicationAndUsage>
<Description>Escitalopram tablets USP contains escitalopram a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP, for oral use, are film-coated, round tablets containing 6.385 mg, 12.77 mg, 25.54 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. Inactive ingredients for 5 mg, 10 mg and 20 mg strengths include croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicified microcrystalline cellulose, talc and titanium dioxide. Escitalopram tablets USP meets USP Dissolution Test 2.</Description>
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