RESTful Lookup — Test-Drive (2007 – 2026)

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    <NDCCode>42571-263-64</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (42571-263-64) </PackageDescription>
    <NDC11Code>42571-0263-64</NDC11Code>
    <ProductNDC>42571-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ticagrelor</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20261101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208539</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>90</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>2026-11-03</LastUpdate>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ticagrelor tablets are a P2Y 12platelet 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 contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a white or off-white to pale pink crystalline powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. Ticagrelor tablets 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide yellow, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, talc, titanium dioxide. Ticagrelor tablets 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide red, ferrosoferric oxide, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, titanium dioxide.</Description>
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    <NDCCode>37808-263-64</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37808-263-64)  / 28 g in 1 TUBE</PackageDescription>
    <NDC11Code>37808-0263-64</NDC11Code>
    <ProductNDC>37808-263</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triple Antibiotic</ProprietaryName>
    <NonProprietaryName>Bacitracin Zinc, Neomycin, Polymyxin B</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141014</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>H E B</LabelerName>
    <SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
    <StrengthNumber>400; 3.5; 5000</StrengthNumber>
    <StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis &amp; Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
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  <NDC>
    <NDCCode>42571-324-64</NDCCode>
    <PackageDescription>180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-64) </PackageDescription>
    <NDC11Code>42571-0324-64</NDC11Code>
    <ProductNDC>42571-324</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranolazine</ProprietaryName>
    <NonProprietaryName>Ranolazine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211745</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>RANOLAZINE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
    <Description>Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N­ (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide.</Description>
  </NDC>
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    <NDCCode>42571-325-64</NDCCode>
    <PackageDescription>180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-325-64) </PackageDescription>
    <NDC11Code>42571-0325-64</NDC11Code>
    <ProductNDC>42571-325</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranolazine</ProprietaryName>
    <NonProprietaryName>Ranolazine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211745</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>RANOLAZINE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
    <Description>Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N­ (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-263-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42571-263-05) </PackageDescription>
    <NDC11Code>42571-0263-05</NDC11Code>
    <ProductNDC>42571-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ticagrelor</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20261101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208539</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>90</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>2026-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ticagrelor tablets are a P2Y 12platelet 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 contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a white or off-white to pale pink crystalline powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. Ticagrelor tablets 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide yellow, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, talc, titanium dioxide. Ticagrelor tablets 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide red, ferrosoferric oxide, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-263-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42571-263-10) </PackageDescription>
    <NDC11Code>42571-0263-10</NDC11Code>
    <ProductNDC>42571-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ticagrelor</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20261101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208539</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>90</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>2026-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ticagrelor tablets are a P2Y 12platelet 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 contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a white or off-white to pale pink crystalline powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. Ticagrelor tablets 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide yellow, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, talc, titanium dioxide. Ticagrelor tablets 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide red, ferrosoferric oxide, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, titanium dioxide.</Description>
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    <NDCCode>42571-263-11</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (42571-263-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-263-32) </PackageDescription>
    <NDC11Code>42571-0263-11</NDC11Code>
    <ProductNDC>42571-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ticagrelor</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20261101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208539</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>90</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>2026-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ticagrelor tablets are a P2Y 12platelet 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 contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a white or off-white to pale pink crystalline powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. Ticagrelor tablets 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide yellow, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, talc, titanium dioxide. Ticagrelor tablets 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide red, ferrosoferric oxide, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, titanium dioxide.</Description>
  </NDC>
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    <NDCCode>42571-263-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42571-263-60) </PackageDescription>
    <NDC11Code>42571-0263-60</NDC11Code>
    <ProductNDC>42571-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ticagrelor</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20261101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208539</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>90</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>2026-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ticagrelor tablets are a P2Y 12platelet 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 contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a white or off-white to pale pink crystalline powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. Ticagrelor tablets 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide yellow, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, talc, titanium dioxide. Ticagrelor tablets 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, ferric oxide red, ferrosoferric oxide, hydroxypropyl cellulose, hypromelloses, magnesium stearate, mannitol, polyethylene glycol, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-263-30</NDCCode>
    <PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (51407-263-30) </PackageDescription>
    <NDC11Code>51407-0263-30</NDC11Code>
    <ProductNDC>51407-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091265</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. ( 1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6­-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3­-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2) Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b][1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.43 g/mol. The chemical structure is:. Olanzapine is a yellow powder. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose and sucralose. Meets USP Disintegration Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-263-79</NDCCode>
    <PackageDescription>10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-263-79) </PackageDescription>
    <NDC11Code>55111-0263-79</NDC11Code>
    <ProductNDC>55111-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076534</ApplicationNumber>
    <LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Olanzapine  USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine USP equivalent to 5 mg (16 µmol), 10 mg  (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets USP also contains the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose and guar gum (Avicel CE-15), microcrystalline cellulose (Avicel PH 101), microcrystalline cellulose (Avicel PH 112), pregelatinized starch and sodium lauryl sulphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-263-81</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (55111-263-81)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55111-0263-81</NDC11Code>
    <ProductNDC>55111-263</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076534</ApplicationNumber>
    <LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Olanzapine  USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine USP equivalent to 5 mg (16 µmol), 10 mg  (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets USP also contains the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose and guar gum (Avicel CE-15), microcrystalline cellulose (Avicel PH 101), microcrystalline cellulose (Avicel PH 112), pregelatinized starch and sodium lauryl sulphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-387-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (42571-387-01) </PackageDescription>
    <NDC11Code>42571-0387-01</NDC11Code>
    <ProductNDC>42571-387</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-387-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (42571-387-10) </PackageDescription>
    <NDC11Code>42571-0387-10</NDC11Code>
    <ProductNDC>42571-387</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-387-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (42571-387-30) </PackageDescription>
    <NDC11Code>42571-0387-30</NDC11Code>
    <ProductNDC>42571-387</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-388-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (42571-388-01) </PackageDescription>
    <NDC11Code>42571-0388-01</NDC11Code>
    <ProductNDC>42571-388</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-388-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (42571-388-10) </PackageDescription>
    <NDC11Code>42571-0388-10</NDC11Code>
    <ProductNDC>42571-388</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-388-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (42571-388-30) </PackageDescription>
    <NDC11Code>42571-0388-30</NDC11Code>
    <ProductNDC>42571-388</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-389-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (42571-389-01) </PackageDescription>
    <NDC11Code>42571-0389-01</NDC11Code>
    <ProductNDC>42571-389</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-389-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (42571-389-10) </PackageDescription>
    <NDC11Code>42571-0389-10</NDC11Code>
    <ProductNDC>42571-389</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-389-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (42571-389-30) </PackageDescription>
    <NDC11Code>42571-0389-30</NDC11Code>
    <ProductNDC>42571-389</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216232</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
    <Description>Fluoxetine capsule, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of  C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg capsule contains FD&amp;C Blue No. 1; the 20 mg capsule contains patent blue V; and the 40 mg capsule also contains patent blue V, ponceau 4R and D&amp;C Yellow No. 10. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. FDA approved dissolution test and specification differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-435-72</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (42571-435-72)  / 1 mL in 1 VIAL (42571-435-54) </PackageDescription>
    <NDC11Code>42571-0435-72</NDC11Code>
    <ProductNDC>42571-435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carboprost Tromethamine</ProprietaryName>
    <NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20240801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218013</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion.</IndicationAndUsage>
    <Description>Carboprost tromethamine injection, USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are. The molecular formula is C 25H 47O 8N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating. Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of carboprost tromethamine injection, USP contains carboprost tromethamine, USP equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0025-10</NDCCode>
    <PackageDescription>12 POUCH in 1 CASE (0409-0025-10)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0025-01) </PackageDescription>
    <NDC11Code>00409-0025-10</NDC11Code>
    <ProductNDC>0409-0025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dobutamine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dobutamine In Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260316</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020201</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
    <Description>Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0151-10</NDCCode>
    <PackageDescription>12 POUCH in 1 CASE (0409-0151-10)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0151-01) </PackageDescription>
    <NDC11Code>00409-0151-10</NDC11Code>
    <ProductNDC>0409-0151</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dobutamine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dobutamine In Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260316</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020201</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
    <Description>Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1100-10</NDCCode>
    <PackageDescription>12 POUCH in 1 CASE (0409-1100-10)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-1100-01) </PackageDescription>
    <NDC11Code>00409-1100-10</NDC11Code>
    <ProductNDC>0409-1100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dobutamine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dobutamine In Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260316</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020201</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
    <Description>Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-2346-32</NDCCode>
    <PackageDescription>12 POUCH in 1 CASE (0409-2346-32)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-2346-31) </PackageDescription>
    <NDC11Code>00409-2346-32</NDC11Code>
    <ProductNDC>0409-2346</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dobutamine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dobutamine In Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050812</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020201</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
    <Description>Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-2347-32</NDCCode>
    <PackageDescription>12 POUCH in 1 CASE (0409-2347-32)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-2347-31) </PackageDescription>
    <NDC11Code>00409-2347-32</NDC11Code>
    <ProductNDC>0409-2347</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dobutamine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dobutamine In Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20060120</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020201</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
    <Description>Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-3724-32</NDCCode>
    <PackageDescription>12 POUCH in 1 CASE (0409-3724-32)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-3724-11) </PackageDescription>
    <NDC11Code>00409-3724-32</NDC11Code>
    <ProductNDC>0409-3724</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dobutamine In Dextrose</ProprietaryName>
    <NonProprietaryName>Dobutamine In Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20051012</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020201</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
    <Description>Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
  </NDC>
  <NDC>
    <NDCCode>0456-0400-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10)  / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) </PackageDescription>
    <NDC11Code>00456-0400-10</NDC11Code>
    <ProductNDC>0456-0400</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teflaro</ProprietaryName>
    <NonProprietaryName>Ceftaroline Fosamil</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20101029</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200327</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>CEFTAROLINE FOSAMIL</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
    <Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0456-0600-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10)  / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) </PackageDescription>
    <NDC11Code>00456-0600-10</NDC11Code>
    <ProductNDC>0456-0600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teflaro</ProprietaryName>
    <NonProprietaryName>Ceftaroline Fosamil</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20101029</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200327</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>CEFTAROLINE FOSAMIL</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
    <Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>10237-263-04</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-263-04)  / 113.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0263-04</NDC11Code>
    <ProductNDC>10237-263</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Therabreath Fresh Breath Anticavity Mild Mint</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240208</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.24</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-02-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aids in the prevention of dental decay.</IndicationAndUsage>
  </NDC>
</NDCList>