RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>72205-433-02</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (72205-433-02) </PackageDescription>
    <NDC11Code>72205-0433-02</NDC11Code>
    <ProductNDC>72205-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin</ProprietaryName>
    <NonProprietaryName>Dapagliflozin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211478</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN</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>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin tablet is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors., 2  As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. .</IndicationAndUsage>
    <Description>Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin tablets, USP is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-433-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72205-433-01) </PackageDescription>
    <NDC11Code>72205-0433-01</NDC11Code>
    <ProductNDC>72205-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin</ProprietaryName>
    <NonProprietaryName>Dapagliflozin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211478</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN</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>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin tablet is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors., 2  As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. .</IndicationAndUsage>
    <Description>Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin tablets, USP is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-433-03</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (72205-433-03) </PackageDescription>
    <NDC11Code>72205-0433-03</NDC11Code>
    <ProductNDC>72205-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin</ProprietaryName>
    <NonProprietaryName>Dapagliflozin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211478</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN</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>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin tablet is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors., 2  As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. .</IndicationAndUsage>
    <Description>Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin tablets, USP is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-195-02</NDCCode>
    <PackageDescription>6 VIAL, SINGLE-DOSE in 1 CARTON (72205-195-02)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>72205-0195-02</NDC11Code>
    <ProductNDC>72205-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isosulfan Blue</ProprietaryName>
    <NonProprietaryName>Isosulfan Blue</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20220916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216090</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ISOSULFAN BLUE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isosulfan blue injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities (1.1).</IndicationAndUsage>
    <Description>The chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is.  ISOSULFAN BLUE. Isosulfan blue injection 1% is a sterile aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8 to 7.4. Each mL of solution contains 10 mg isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. The solution contains no preservative. Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-389-02</NDCCode>
    <PackageDescription>90 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-389-02) </PackageDescription>
    <NDC11Code>72205-0389-02</NDC11Code>
    <ProductNDC>72205-389</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Deferasirox</ProprietaryName>
    <NonProprietaryName>Deferasirox</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209878</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DEFERASIROX</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1) Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2)Limitations of Use:  The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
    <Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1- yl]-benzoic acid and its structural formula is.  Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol.Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K30) and sodium lauryl sulphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-390-02</NDCCode>
    <PackageDescription>90 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-390-02) </PackageDescription>
    <NDC11Code>72205-0390-02</NDC11Code>
    <ProductNDC>72205-390</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Deferasirox</ProprietaryName>
    <NonProprietaryName>Deferasirox</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209878</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DEFERASIROX</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1) Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2)Limitations of Use:  The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
    <Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1- yl]-benzoic acid and its structural formula is.  Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol.Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K30) and sodium lauryl sulphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-391-02</NDCCode>
    <PackageDescription>90 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-391-02) </PackageDescription>
    <NDC11Code>72205-0391-02</NDC11Code>
    <ProductNDC>72205-391</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Deferasirox</ProprietaryName>
    <NonProprietaryName>Deferasirox</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209878</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DEFERASIROX</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1) Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2)Limitations of Use:  The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
    <Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1- yl]-benzoic acid and its structural formula is.  Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol.Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K30) and sodium lauryl sulphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-406-02</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (72205-406-02) </PackageDescription>
    <NDC11Code>72205-0406-02</NDC11Code>
    <ProductNDC>72205-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ticagrelor</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208596</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ticagrelor tablets are a P2Y12 platelet inhibitor indicated: 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.  Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).</IndicationAndUsage>
    <Description>Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-­difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-­hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, magnesium stearate and mannitol. The tablets are film-coated with a coating material containing hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol 400, talc and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, magnesium stearate and mannitol. The tablets are film-coated with a coating material containing hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol 400, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-407-02</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (72205-407-02) </PackageDescription>
    <NDC11Code>72205-0407-02</NDC11Code>
    <ProductNDC>72205-407</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Linagliptin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208459</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</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>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have 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 linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Linagliptin and metformin hydrochloride tablets for oral use contain: linagliptin and metformin hydrochloride.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 (&lt;1 mg/mL), and very slightly soluble in acetone (ca.1 mg/mL). Metformin Hydrochloride  Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63 g/mol. Metformin hydrochloride 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. Linagliptin and Metformin Hydrochloride Tablets. Linagliptin and metformin hydrochloride tablets are available for oral administration as tablets containing:     2.5 mg linagliptin and 500 mg metformin hydrochloride (equivalent to 389.93 mg of metformin)     2.5 mg linagliptin and 850 mg metformin hydrochloride (equivalent 662.88 mg of metformin)     2.5 mg linagliptin and 1,000 mg metformin hydrochloride (equivalent to 779.86 mg of metformin) Each film-coated tablet of linagliptin and metformin hydrochloride tablets contains the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, magnesium stearate, meglumine, povidone, propylene glycol, titanium dioxide, talc, yellow iron oxide (2.5 mg/500 mg; 2.5 mg/850 mg) and/or red iron oxide (2.5 mg/850 mg; 2.5 mg/1,000 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-408-02</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (72205-408-02) </PackageDescription>
    <NDC11Code>72205-0408-02</NDC11Code>
    <ProductNDC>72205-408</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Linagliptin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208459</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LINAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5; 850</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>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have 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 linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Linagliptin and metformin hydrochloride tablets for oral use contain: linagliptin and metformin hydrochloride.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 (&lt;1 mg/mL), and very slightly soluble in acetone (ca.1 mg/mL). Metformin Hydrochloride  Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63 g/mol. Metformin hydrochloride 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. Linagliptin and Metformin Hydrochloride Tablets. Linagliptin and metformin hydrochloride tablets are available for oral administration as tablets containing:     2.5 mg linagliptin and 500 mg metformin hydrochloride (equivalent to 389.93 mg of metformin)     2.5 mg linagliptin and 850 mg metformin hydrochloride (equivalent 662.88 mg of metformin)     2.5 mg linagliptin and 1,000 mg metformin hydrochloride (equivalent to 779.86 mg of metformin) Each film-coated tablet of linagliptin and metformin hydrochloride tablets contains the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, magnesium stearate, meglumine, povidone, propylene glycol, titanium dioxide, talc, yellow iron oxide (2.5 mg/500 mg; 2.5 mg/850 mg) and/or red iron oxide (2.5 mg/850 mg; 2.5 mg/1,000 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-409-02</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (72205-409-02) </PackageDescription>
    <NDC11Code>72205-0409-02</NDC11Code>
    <ProductNDC>72205-409</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Linagliptin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Linagliptin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208459</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LINAGLIPTIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5; 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>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have 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 linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Linagliptin and metformin hydrochloride tablets for oral use contain: linagliptin and metformin hydrochloride.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 (&lt;1 mg/mL), and very slightly soluble in acetone (ca.1 mg/mL). Metformin Hydrochloride  Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63 g/mol. Metformin hydrochloride 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. Linagliptin and Metformin Hydrochloride Tablets. Linagliptin and metformin hydrochloride tablets are available for oral administration as tablets containing:     2.5 mg linagliptin and 500 mg metformin hydrochloride (equivalent to 389.93 mg of metformin)     2.5 mg linagliptin and 850 mg metformin hydrochloride (equivalent 662.88 mg of metformin)     2.5 mg linagliptin and 1,000 mg metformin hydrochloride (equivalent to 779.86 mg of metformin) Each film-coated tablet of linagliptin and metformin hydrochloride tablets contains the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, magnesium stearate, meglumine, povidone, propylene glycol, titanium dioxide, talc, yellow iron oxide (2.5 mg/500 mg; 2.5 mg/850 mg) and/or red iron oxide (2.5 mg/850 mg; 2.5 mg/1,000 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-416-02</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (72205-416-02)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>72205-0416-02</NDC11Code>
    <ProductNDC>72205-416</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rivaroxaban</ProprietaryName>
    <NonProprietaryName>Rivaroxaban</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208546</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>RIVAROXABAN</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>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8)  .</IndicationAndUsage>
    <Description>Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban, USP is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Opadry® Yellow, containing hypromellose, titanium dioxide, polyethylene glycol 3350 and  iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-432-02</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (72205-432-02) </PackageDescription>
    <NDC11Code>72205-0432-02</NDC11Code>
    <ProductNDC>72205-432</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin</ProprietaryName>
    <NonProprietaryName>Dapagliflozin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211478</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN</SubstanceName>
    <StrengthNumber>5</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>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin tablet is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors., 2  As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. .</IndicationAndUsage>
    <Description>Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin tablets, USP is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-434-02</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-434-02) </PackageDescription>
    <NDC11Code>72205-0434-02</NDC11Code>
    <ProductNDC>72205-434</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211479</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
    <Description>Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The   pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release  Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-435-02</NDCCode>
    <PackageDescription>400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-02) </PackageDescription>
    <NDC11Code>72205-0435-02</NDC11Code>
    <ProductNDC>72205-435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211479</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 1000</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
    <Description>Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The   pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release  Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-436-02</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-436-02) </PackageDescription>
    <NDC11Code>72205-0436-02</NDC11Code>
    <ProductNDC>72205-436</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211479</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
    <Description>Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The   pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release  Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-437-02</NDCCode>
    <PackageDescription>400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-437-02) </PackageDescription>
    <NDC11Code>72205-0437-02</NDC11Code>
    <ProductNDC>72205-437</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211479</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10; 1000</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
    <Description>Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The   pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release  Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-438-02</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (72205-438-02) </PackageDescription>
    <NDC11Code>72205-0438-02</NDC11Code>
    <ProductNDC>72205-438</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin And Saxagliptin</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Saxagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211533</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE</SubstanceName>
    <StrengthNumber>10; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin and saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin and saxagliptin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.1)].</IndicationAndUsage>
    <Description>Dapagliflozin and saxagliptin tablets for oral use contain dapagliflozin and saxagliptin. Dapagliflozin is an active inhibitor of sodium-glucose cotransporter 2 (SGLT2). It is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol with an molecular formula as C21H25ClO6  and the  molecular weight of  408.88.The structural formula is. Saxagliptin is an active inhibitor of the dipeptidyl-peptidase-4 (DPP-4) enzyme. It is isolated in the dihydrate form chemically known as (1S, 3S, 5S)-2-((2S)-2-amino-2-(3-hydroxyadamantan-1-yl) acetyl)-2-azabicyclo [3.1.0] hexane-3-carbonitrile hydrochloride dihydrate. The molecular formula is C18H25N3O2.HCl.2H2O and the molecular weight is 387.90. The structural formula is. Dapagliflozin and saxagliptin tablet is available as film-coated tablet:  10 mg dapagliflozin / 5 mg saxagliptin. Each tablet contains 10 mg dapagliflozin and 5 mg saxagliptin (equivalent to 5.58 mg saxagliptin hydrochloride). Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, stearic acid, iron oxide yellow, iron oxide red, polyvinyl alcohol, polyethylene glycol, talc and  titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-478-02</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (72205-478-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (72205-478-01) </PackageDescription>
    <NDC11Code>72205-0478-02</NDC11Code>
    <ProductNDC>72205-478</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214368</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-­ 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only.  Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is  between  300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-­carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-479-02</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (72205-479-02)  / 5 mL in 1 VIAL, SINGLE-DOSE (72205-479-01) </PackageDescription>
    <NDC11Code>72205-0479-02</NDC11Code>
    <ProductNDC>72205-479</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214368</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-­ 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only.  Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is  between  300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-­carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>35573-433-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (35573-433-02) </PackageDescription>
    <NDC11Code>35573-0433-02</NDC11Code>
    <ProductNDC>35573-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketoconazole</ProprietaryName>
    <NonProprietaryName>Ketoconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075912</ApplicationNumber>
    <LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>KETOCONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.</IndicationAndUsage>
    <Description>Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the following structural formula. Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44g/mol. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-433-02</NDCCode>
    <PackageDescription>2 BOTTLE, PUMP in 1 CARTON (37000-433-02)  / 15 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>37000-0433-02</NDC11Code>
    <ProductNDC>37000-433</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vicks Sinex</ProprietaryName>
    <ProprietaryNameSuffix>12 Hour Decongestant Ultra Fine Mist</ProprietaryNameSuffix>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20150427</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.0005095</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50111-433-02</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (50111-433-02) </PackageDescription>
    <NDC11Code>50111-0433-02</NDC11Code>
    <ProductNDC>50111-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <EndMarketingDate>20220630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071523</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50580-433-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (50580-433-02)  / 60 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>50580-0433-02</NDC11Code>
    <ProductNDC>50580-433</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infants Tylenol</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170807</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to: the common coldfluheadachesore throattoothache.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51346-433-02</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51346-433-02)  &gt; 15 g in 1 BOTTLE, PLASTIC (51346-433-01)</PackageDescription>
    <NDC11Code>51346-0433-02</NDC11Code>
    <ProductNDC>51346-433</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Provence Calendula Aqua Sun</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octinoxate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
    <StrengthNumber>1.05; .67</StrengthNumber>
    <StrengthUnit>g/15g; g/15g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-09</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51607-001-02</NDCCode>
    <PackageDescription>433 L in 1 CYLINDER (51607-001-02) </PackageDescription>
    <NDC11Code>51607-0001-02</NDC11Code>
    <ProductNDC>51607-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19380101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205865</ApplicationNumber>
    <LabelerName>Star Weld</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>990</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52125-433-02</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BLISTER PACK (52125-433-02)</PackageDescription>
    <NDC11Code>52125-0433-02</NDC11Code>
    <ProductNDC>52125-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130122</StartMarketingDate>
    <EndMarketingDate>20170203</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065055</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>54575-433-02</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (54575-433-02)</PackageDescription>
    <NDC11Code>54575-0433-02</NDC11Code>
    <ProductNDC>54575-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Peanut Food</ProprietaryName>
    <NonProprietaryName>Peanut</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>PEANUT</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>55150-434-02</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (55150-434-02)  *  25 mL in 1 VIAL, SINGLE-DOSE (55150-432-02)  *  25 mL in 1 VIAL (55150-433-02) </PackageDescription>
    <NDC11Code>55150-0434-02</NDC11Code>
    <ProductNDC>55150-434</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexrazoxane</ProprietaryName>
    <NonProprietaryName>Dexrazoxane</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160512</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200752</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>Dexrazoxane for injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (S)-4,4’-(1-methyl-1,2-ethanediyl)bis-2,6- piperazinedione. The structural formula is as follows. Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane for injection is a white to off-white or pale pink lyophilized powder or cake that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pKa is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0. Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with the 25 mL vial of 0.167 Molar (M/6) Sodium Lactate Injection, USP diluent provided, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 3.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>55648-433-02</NDCCode>
    <PackageDescription>1000 TABLET, DELAYED RELEASE in 1 BOTTLE (55648-433-02)</PackageDescription>
    <NDC11Code>55648-0433-02</NDC11Code>
    <ProductNDC>55648-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091231</ApplicationNumber>
    <LabelerName>WOCKHARDT LIMITED</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate, USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water and practically insoluble in hexane.The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.Pantoprazole sodium is supplied as a delayed-release tablet for oral administration, available in 2 strengths (40 mg and 20 mg). Each delayed-release tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: aerosil 200, calcium stearate, colloidal silicon dioxide, mannitol, pregelatinized starch, shellac glaze, sodium carbonate anhydrous, sodium starch glycolate and talc. Each delayed-release tablet contains ammonium hydroxide, eudragit L 100-55, FD and C Blue #2, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 6000, propylene glycol, sodium hydroxide, titanium dioxide and triethyl citrate as the coating ingredients.Pantoprazole sodium delayed-release tablets USP, 20 mg and 40 mg, meet USP Dissolution Test 3.</Description>
  </NDC>
</NDCList>