{
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{
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"NDC11Code": "55154-4837-08",
"ProductNDC": "55154-4837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedical",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20001211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075289",
"LabelerName": "Cardinal Health",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-07",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20001211",
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{
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"ProductNDC": "55154-4837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedical",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Nifedipine",
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"RouteName": "ORAL",
"StartMarketingDate": "20001211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075289",
"LabelerName": "Cardinal Health",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20001211",
"SamplePackage": "N"
},
{
"NDCCode": "0006-4837-02",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0006-4837-02) > .5 mL in 1 SYRINGE, GLASS (0006-4837-01) ",
"NDC11Code": "00006-4837-02",
"ProductNDC": "0006-4837",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Pneumovax 23",
"NonProprietaryName": "Pneumococcal Vaccine Polyvalent",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20140721",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101094",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN",
"StrengthNumber": "25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140721",
"SamplePackage": "N"
},
{
"NDCCode": "0006-4837-03",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (0006-4837-03) / .5 mL in 1 SYRINGE, GLASS (0006-4837-01) ",
"NDC11Code": "00006-4837-03",
"ProductNDC": "0006-4837",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Pneumovax 23",
"NonProprietaryName": "Pneumococcal Vaccine Polyvalent",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20140721",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101094",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN",
"StrengthNumber": "25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140721",
"SamplePackage": "N",
"IndicationAndUsage": "PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). (1.1). PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease. (1.1, 14.1).",
"Description": "PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). PNEUMOVAX 23 is a clear, colorless solution. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. The vaccine is used directly as supplied. No dilution or reconstitution is necessary. The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex."
},
{
"NDCCode": "55154-0103-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-0103-8) > 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-0103-08",
"ProductNDC": "55154-0103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050228",
"EndMarketingDate": "20191130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018803",
"LabelerName": "Cardinal Health",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050228",
"EndMarketingDatePackage": "20191130",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0119-8",
"PackageDescription": "1 VIAL in 1 BAG (55154-0119-8) > 50 mL in 1 VIAL",
"NDC11Code": "55154-0119-08",
"ProductNDC": "55154-0119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19850418",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cardinal Health",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19850418",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0120-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-0120-8) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-0120-08",
"ProductNDC": "55154-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20110727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074802",
"LabelerName": "Cardinal Health",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110727",
"EndMarketingDatePackage": "20191031",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0124-8",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (55154-0124-8) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "55154-0124-08",
"ProductNDC": "55154-0124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20100330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088299",
"LabelerName": "Cardinal Health",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100330",
"EndMarketingDatePackage": "20191130",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0127-8",
"PackageDescription": "1 VIAL in 1 BAG (55154-0127-8) > 10 mL in 1 VIAL",
"NDC11Code": "55154-0127-08",
"ProductNDC": "55154-0127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sterile Water",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20110915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018801",
"LabelerName": "Cardinal Health",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110915",
"EndMarketingDatePackage": "20190531",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0132-8",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (55154-0132-8) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "55154-0132-08",
"ProductNDC": "55154-0132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride Anhydrous And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20100405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Cardinal Health",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0147-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-0147-8) > 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-0147-08",
"ProductNDC": "55154-0147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20100330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088329",
"LabelerName": "Cardinal Health",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-02-06",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0149-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-0149-8) > 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-0149-08",
"ProductNDC": "55154-0149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20110727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074802",
"LabelerName": "Cardinal Health",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110727",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0155-8",
"PackageDescription": "1 PACKET in 1 BAG (55154-0155-8) > .9 g in 1 PACKET",
"NDC11Code": "55154-0155-08",
"ProductNDC": "55154-0155",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin Zinc",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110602",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Cardinal Health",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0218-8",
"PackageDescription": "2200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0218-8) ",
"NDC11Code": "55154-0218-08",
"ProductNDC": "55154-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Conjugated Estrogens",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Cardinal Health",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0219-8",
"PackageDescription": "1400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0219-8) ",
"NDC11Code": "55154-0219-08",
"ProductNDC": "55154-0219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Conjugated Estrogens",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Cardinal Health",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0256-8",
"PackageDescription": "2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8) ",
"NDC11Code": "55154-0256-08",
"ProductNDC": "55154-0256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131002",
"SamplePackage": "N",
"IndicationAndUsage": "TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)."
},
{
"NDCCode": "55154-0257-8",
"PackageDescription": "2430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8) ",
"NDC11Code": "55154-0257-08",
"ProductNDC": "55154-0257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131002",
"SamplePackage": "N",
"IndicationAndUsage": "TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)."
},
{
"NDCCode": "55154-0328-8",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0328-8) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0328-08",
"ProductNDC": "55154-0328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Cardinal Health",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0375-8",
"PackageDescription": "1 VIAL in 1 BAG (55154-0375-8) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "55154-0375-08",
"ProductNDC": "55154-0375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ceftriaxone",
"NonProprietaryName": "Ceftriaxone",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065465",
"LabelerName": "Cardinal Health",
"SubstanceName": "CEFTRIAXONE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0407-8",
"PackageDescription": "4000 CAPSULE in 1 BOTTLE, PLASTIC (55154-0407-8)",
"NDC11Code": "55154-0407-08",
"ProductNDC": "55154-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flomax",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970912",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020579",
"LabelerName": "Cardinal Health",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "55154-0410-8",
"PackageDescription": "2640 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0410-8) ",
"NDC11Code": "55154-0410-08",
"ProductNDC": "55154-0410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tradjenta",
"NonProprietaryName": "Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201280",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "LINAGLIPTIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-04",
"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": "55154-0411-8",
"PackageDescription": "720 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0411-8) ",
"NDC11Code": "55154-0411-08",
"ProductNDC": "55154-0411",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jardiance",
"NonProprietaryName": "Empagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204629",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "EMPAGLIFLOZIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140801",
"SamplePackage": "N",
"IndicationAndUsage": "JARDIANCE is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure., 2 to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression., 3 to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease., 4 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.",
"Description": "JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the SGLT2. The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S). Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is. Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile, soluble in 50% acetonitrile/water, and practically insoluble in toluene. Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: ferric oxide yellow, hypromellose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "55154-0412-8",
"PackageDescription": "990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0412-8) ",
"NDC11Code": "55154-0412-08",
"ProductNDC": "55154-0412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jardiance",
"NonProprietaryName": "Empagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204629",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "EMPAGLIFLOZIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140801",
"SamplePackage": "N",
"IndicationAndUsage": "JARDIANCE is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure., 2 to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression., 3 to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease., 4 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.",
"Description": "JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the SGLT2. The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S). Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is. Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile, soluble in 50% acetonitrile/water, and practically insoluble in toluene. Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: ferric oxide yellow, hypromellose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "55154-0534-8",
"PackageDescription": "7560 TABLET, EXTENDED RELEASE in 1 BOTTLE (55154-0534-8)",
"NDC11Code": "55154-0534-08",
"ProductNDC": "55154-0534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19940426",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020329",
"LabelerName": "Cardinal Health",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0537-8",
"PackageDescription": "1200 TABLET in 1 BOTTLE, PLASTIC (55154-0537-8)",
"NDC11Code": "55154-0537-08",
"ProductNDC": "55154-0537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19600915",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA012462",
"LabelerName": "Cardinal Health",
"SubstanceName": "DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE",
"StrengthNumber": "2.5; .025",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2017-12-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0539-8",
"PackageDescription": "7560 TABLET, EXTENDED RELEASE in 1 BOTTLE (55154-0539-8) ",
"NDC11Code": "55154-0539-08",
"ProductNDC": "55154-0539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19940426",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020329",
"LabelerName": "Cardinal Health",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19940426",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0553-8",
"PackageDescription": "3300 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (55154-0553-8) ",
"NDC11Code": "55154-0553-08",
"ProductNDC": "55154-0553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elmiron",
"NonProprietaryName": "Pentosan Polysulfate Sodium",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960926",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020193",
"LabelerName": "Cardinal Health",
"SubstanceName": "PENTOSAN POLYSULFATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycosaminoglycan [EPC],Glycosaminoglycans [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0611-8",
"PackageDescription": "2880 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0611-8)",
"NDC11Code": "55154-0611-08",
"ProductNDC": "55154-0611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Onglyza",
"NonProprietaryName": "Saxagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022350",
"LabelerName": "Cardinal Health",
"SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0612-8",
"PackageDescription": "4140 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0612-8) ",
"NDC11Code": "55154-0612-08",
"ProductNDC": "55154-0612",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eliquis",
"NonProprietaryName": "Apixaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202155",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "APIXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121228",
"SamplePackage": "N",
"IndicationAndUsage": "ELIQUIS is a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy. (1.3, 1.4, 1.5), 4 Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment. (1.6).",
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<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20110727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074802</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110727</StartMarketingDatePackage>
<EndMarketingDatePackage>20191031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0124-8</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (55154-0124-8) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>55154-0124-08</NDC11Code>
<ProductNDC>55154-0124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION</RouteName>
<StartMarketingDate>20100330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088299</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100330</StartMarketingDatePackage>
<EndMarketingDatePackage>20191130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0127-8</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (55154-0127-8) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>55154-0127-08</NDC11Code>
<ProductNDC>55154-0127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sterile Water</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018801</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110915</StartMarketingDatePackage>
<EndMarketingDatePackage>20190531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0132-8</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (55154-0132-8) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>55154-0132-08</NDC11Code>
<ProductNDC>55154-0132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride Anhydrous And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION</RouteName>
<StartMarketingDate>20100405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089644</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0147-8</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (55154-0147-8) > 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55154-0147-08</NDC11Code>
<ProductNDC>55154-0147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20100330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088329</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-06</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0149-8</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (55154-0149-8) > 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55154-0149-08</NDC11Code>
<ProductNDC>55154-0149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20110727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074802</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110727</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0155-8</NDCCode>
<PackageDescription>1 PACKET in 1 BAG (55154-0155-8) > .9 g in 1 PACKET</PackageDescription>
<NDC11Code>55154-0155-08</NDC11Code>
<ProductNDC>55154-0155</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitracin Zinc</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>BACITRACIN ZINC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0218-8</NDCCode>
<PackageDescription>2200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0218-8) </PackageDescription>
<NDC11Code>55154-0218-08</NDC11Code>
<ProductNDC>55154-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premarin</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA004782</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
<StrengthNumber>.45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0219-8</NDCCode>
<PackageDescription>1400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0219-8) </PackageDescription>
<NDC11Code>55154-0219-08</NDC11Code>
<ProductNDC>55154-0219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premarin</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA004782</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0256-8</NDCCode>
<PackageDescription>2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8) </PackageDescription>
<NDC11Code>55154-0256-08</NDC11Code>
<ProductNDC>55154-0256</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>55154-0257-8</NDCCode>
<PackageDescription>2430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8) </PackageDescription>
<NDC11Code>55154-0257-08</NDC11Code>
<ProductNDC>55154-0257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>55154-0328-8</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0328-8) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0328-08</NDC11Code>
<ProductNDC>55154-0328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0375-8</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (55154-0375-8) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>55154-0375-08</NDC11Code>
<ProductNDC>55154-0375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceftriaxone</ProprietaryName>
<NonProprietaryName>Ceftriaxone</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065465</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0407-8</NDCCode>
<PackageDescription>4000 CAPSULE in 1 BOTTLE, PLASTIC (55154-0407-8)</PackageDescription>
<NDC11Code>55154-0407-08</NDC11Code>
<ProductNDC>55154-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flomax</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970912</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020579</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>55154-0410-8</NDCCode>
<PackageDescription>2640 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0410-8) </PackageDescription>
<NDC11Code>55154-0410-08</NDC11Code>
<ProductNDC>55154-0410</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>Cardinal Health 107, LLC</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>2025-09-04</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>55154-0411-8</NDCCode>
<PackageDescription>720 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0411-8) </PackageDescription>
<NDC11Code>55154-0411-08</NDC11Code>
<ProductNDC>55154-0411</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jardiance</ProprietaryName>
<NonProprietaryName>Empagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204629</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>EMPAGLIFLOZIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JARDIANCE is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure., 2 to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression., 3 to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease., 4 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the SGLT2. The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S). Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is. Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile, soluble in 50% acetonitrile/water, and practically insoluble in toluene. Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: ferric oxide yellow, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jardiance</ProprietaryName>
<NonProprietaryName>Empagliflozin</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20140801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204629</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>EMPAGLIFLOZIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JARDIANCE is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure., 2 to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression., 3 to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease., 4 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the SGLT2. The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S). Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is. Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile, soluble in 50% acetonitrile/water, and practically insoluble in toluene. Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: ferric oxide yellow, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55154-0534-8</NDCCode>
<PackageDescription>7560 TABLET, EXTENDED RELEASE in 1 BOTTLE (55154-0534-8)</PackageDescription>
<NDC11Code>55154-0534-08</NDC11Code>
<ProductNDC>55154-0534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940426</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020329</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0537-8</NDCCode>
<PackageDescription>1200 TABLET in 1 BOTTLE, PLASTIC (55154-0537-8)</PackageDescription>
<NDC11Code>55154-0537-08</NDC11Code>
<ProductNDC>55154-0537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19600915</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA012462</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE</SubstanceName>
<StrengthNumber>2.5; .025</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-12-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0539-8</NDCCode>
<PackageDescription>7560 TABLET, EXTENDED RELEASE in 1 BOTTLE (55154-0539-8) </PackageDescription>
<NDC11Code>55154-0539-08</NDC11Code>
<ProductNDC>55154-0539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940426</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020329</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0553-8</NDCCode>
<PackageDescription>3300 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (55154-0553-8) </PackageDescription>
<NDC11Code>55154-0553-08</NDC11Code>
<ProductNDC>55154-0553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elmiron</ProprietaryName>
<NonProprietaryName>Pentosan Polysulfate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960926</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020193</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>PENTOSAN POLYSULFATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycosaminoglycan [EPC],Glycosaminoglycans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0611-8</NDCCode>
<PackageDescription>2880 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0611-8)</PackageDescription>
<NDC11Code>55154-0611-08</NDC11Code>
<ProductNDC>55154-0611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Onglyza</ProprietaryName>
<NonProprietaryName>Saxagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090731</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022350</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</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>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0612-8</NDCCode>
<PackageDescription>4140 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0612-8) </PackageDescription>
<NDC11Code>55154-0612-08</NDC11Code>
<ProductNDC>55154-0612</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eliquis</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202155</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELIQUIS is a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy. (1.3, 1.4, 1.5), 4 Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment. (1.6).</IndicationAndUsage>
<Description>ELIQUIS (apixaban), a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2-6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. ELIQUIS tablets 2.5 mg and 5 mg are available for oral administration and contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets). ELIQUIS 0.5 mg film coated tablets for oral suspension are supplied in packets containing 1 (0.5 mg), 3 (1.5 mg) or 4 (2 mg) apixaban tablets. The inactive ingredients are anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and red iron oxide. ELIQUIS SPRINKLE 0.15 mg for oral suspension is supplied as a white to off-white powder in capsules, which contain 0.15 mg apixaban and the following inactive ingredients: hypromellose and sugar spheres.</Description>
</NDC>
<NDC>
<NDCCode>55154-0613-8</NDCCode>
<PackageDescription>2040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0613-8) </PackageDescription>
<NDC11Code>55154-0613-08</NDC11Code>
<ProductNDC>55154-0613</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eliquis</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202155</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELIQUIS is a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy. (1.3, 1.4, 1.5), 4 Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment. (1.6).</IndicationAndUsage>
<Description>ELIQUIS (apixaban), a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2-6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. ELIQUIS tablets 2.5 mg and 5 mg are available for oral administration and contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets). ELIQUIS 0.5 mg film coated tablets for oral suspension are supplied in packets containing 1 (0.5 mg), 3 (1.5 mg) or 4 (2 mg) apixaban tablets. The inactive ingredients are anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and red iron oxide. ELIQUIS SPRINKLE 0.15 mg for oral suspension is supplied as a white to off-white powder in capsules, which contain 0.15 mg apixaban and the following inactive ingredients: hypromellose and sugar spheres.</Description>
</NDC>
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