RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>63323-531-90</NDCCode>
    <PackageDescription>10 CELLO PACK in 1 CARTON (63323-531-90)  / 1 SYRINGE in 1 CELLO PACK (63323-531-01)  / .8 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>63323-0531-90</NDC11Code>
    <ProductNDC>63323-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enoxaparin Sodium</ProprietaryName>
    <NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020164</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enoxaparin sodium is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism ( 1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism ( 1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) ( 1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (  1.4)  .</IndicationAndUsage>
    <Description>Enoxaparin sodium injection is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. Enoxaparin sodium injection 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin sodium injection 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The enoxaparin sodium prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative [see  Dosage and Administration (2) and  How Supplied/Storage and Handling (16)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-531-98</NDCCode>
    <PackageDescription>10 CELLO PACK in 1 CARTON (63323-531-98)  / 1 SYRINGE in 1 CELLO PACK (63323-531-08)  / .8 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>63323-0531-98</NDC11Code>
    <ProductNDC>63323-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enoxaparin Sodium</ProprietaryName>
    <NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020164</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enoxaparin sodium is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1), 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2), 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2), 4 Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) (1.3), 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4).</IndicationAndUsage>
    <Description>Enoxaparin sodium injection is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA.                    R1 = H or SO3Na and R2 = SO3Na or COCH3. Enoxaparin sodium injection 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin sodium injection 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The enoxaparin sodium prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-568-90</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (63323-568-90)  &gt; .8 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>63323-0568-90</NDC11Code>
    <ProductNDC>63323-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enoxaparin Sodium</ProprietaryName>
    <NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150220</StartMarketingDate>
    <EndMarketingDate>20221130</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020164</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-569-90</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (63323-569-90)  &gt; .8 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>63323-0569-90</NDC11Code>
    <ProductNDC>63323-569</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enoxaparin Sodium</ProprietaryName>
    <NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150220</StartMarketingDate>
    <EndMarketingDate>20201031</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020164</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-609-90</NDCCode>
    <PackageDescription>10 CELLO PACK in 1 CARTON (63323-609-90)  / 1 SYRINGE in 1 CELLO PACK (63323-609-01)  / .8 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>63323-0609-90</NDC11Code>
    <ProductNDC>63323-609</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enoxaparin Sodium</ProprietaryName>
    <NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190618</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020164</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enoxaparin sodium is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism ( 1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism ( 1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) ( 1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (  1.4)  .</IndicationAndUsage>
    <Description>Enoxaparin sodium injection is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. Enoxaparin sodium injection 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin sodium injection 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The enoxaparin sodium prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative [see  Dosage and Administration (2) and  How Supplied/Storage and Handling (16)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-651-90</NDCCode>
    <PackageDescription>10 SYRINGE, PLASTIC in 1 CARTON (63323-651-90)  &gt; 4 mL in 1 SYRINGE, PLASTIC (63323-651-23) </PackageDescription>
    <NDC11Code>63323-0651-90</NDC11Code>
    <ProductNDC>63323-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adenosine</ProprietaryName>
    <NonProprietaryName>Adenosine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205568</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ADENOSINE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-03-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous adenosine injection, USP is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome).  When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection, USP administration. It is important to be sure the adenosine injection, USP solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine injection, USP does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm.  In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection, USP administration.</IndicationAndUsage>
    <Description>Adenosine is an endogenous nucleoside occurring in all cells of the body.  It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula. C10H13N5O4                            M.W. 267.24. Adenosine is a white crystalline powder.  It is soluble in water and practically insoluble in alcohol.  Solubility increases by warming and lowering the pH.  Adenosine is not chemically related to other antiarrhythmic drugs.  Adenosine injection, USP is a sterile, nonpyrogenic solution for rapid bolus intravenous injection.  Each mL contains 3 mg adenosine and 9 mg sodium chloride in water for injection.  The pH of the solution is between 4.5 and 7.5. The TopPac® plastic syringe is molded from a specially formulated cyclo olefin copolymer.  Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts which have been toxicologically assessed and are within the safety margins.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-942-90</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (63323-942-90)  &gt; 5 mL in 1 SYRINGE (63323-942-42) </PackageDescription>
    <NDC11Code>63323-0942-90</NDC11Code>
    <ProductNDC>63323-942</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Palonosetron</ProprietaryName>
    <NonProprietaryName>Palonosetron</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208109</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-03-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10544-531-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (10544-531-90)</PackageDescription>
    <NDC11Code>10544-0531-90</NDC11Code>
    <ProductNDC>10544-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-531-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (55700-531-90)</PackageDescription>
    <NDC11Code>55700-0531-90</NDC11Code>
    <ProductNDC>55700-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atenolol</ProprietaryName>
    <NonProprietaryName>Atenolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076900</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>ATENOLOL</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-29</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60429-531-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60429-531-90)</PackageDescription>
    <NDC11Code>60429-0531-90</NDC11Code>
    <ProductNDC>60429-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080222</StartMarketingDate>
    <EndMarketingDate>20140830</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078184</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2014-09-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>61919-531-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-531-90) </PackageDescription>
    <NDC11Code>61919-0531-90</NDC11Code>
    <ProductNDC>61919-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090548</ApplicationNumber>
    <LabelerName>DirectRX</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.1.1 Prevention of Cardiovascular Disease  In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to:Reduce the risk of myocardial infarctionReduce the risk of strokeReduce the risk for revascularization procedures and anginaIn patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to:Reduce the risk of myocardial infarctionReduce the risk of stroke In patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to:Reduce the risk of non-fatal myocardial infarctionReduce the risk of fatal and non-fatal strokeReduce the risk for revascularization proceduresReduce the risk of hospitalization for CHFReduce the risk of angina  1.2 Hyperlipidemia  Atorvastatin calcium tablets are indicated As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:  a. LDL-C remains ≥ 190 mg/dL orb. LDL-C remains ≥ 160 mg/dL and:there is a positive family history of premature cardiovascular disease ortwo or more other CVD risk factors are present in the pediatric patient1.3 Limitations of Use Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). .</IndicationAndUsage>
    <Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug substance used in atorvastatin calcium tablets is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46. Its structural formula is. chemical-structure. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate (vegetable source), colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-531-16</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-531-16) </PackageDescription>
    <NDC11Code>68382-0531-16</NDC11Code>
    <ProductNDC>68382-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203553</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].</IndicationAndUsage>
    <Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below.                                      C23H27N3O7HCl             M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD &amp; C blue #2 aluminum lake; the 80 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 90 mg tablets contain D &amp; C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 115 mg tablets contain FD &amp; C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D &amp; C red #27 aluminum lake, D &amp; C yellow #10 aluminum lake and FD &amp; C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-531-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71205-531-90) </PackageDescription>
    <NDC11Code>71205-0531-90</NDC11Code>
    <ProductNDC>71205-531</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fexofenadine Hcl</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160819</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204097</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. §  runny nose. §  sneezing. §  itchy, watery eyes. §  itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71610-531-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (71610-531-60) </PackageDescription>
    <NDC11Code>71610-0531-60</NDC11Code>
    <ProductNDC>71610-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carisoprodol</ProprietaryName>
    <NonProprietaryName>Carisoprodol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190808</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040245</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>CARISOPRODOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.       Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Carisoprodol Tablets USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:.       Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-531-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (72189-531-90) </PackageDescription>
    <NDC11Code>72189-0531-90</NDC11Code>
    <ProductNDC>72189-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213853</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>ATORVASTATIN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets is indicated. To reduce the risk of. Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:. Primary dysbetalipoproteinemia Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca3H 2O and its molecular weight is 1209.42. Its structural formula is. [image description]. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF; Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Opadry Complete film coating system YS-1-7040 White (Hypromellose, Macrogol, Talc and Titanium dioxide).</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-531-03</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (59651-531-03) </PackageDescription>
    <NDC11Code>59651-0531-03</NDC11Code>
    <ProductNDC>59651-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Erlotinib</ProprietaryName>
    <NonProprietaryName>Erlotinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216342</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>ERLOTINIB HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Erlotinib tablets are a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1) , 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2) .</IndicationAndUsage>
    <Description>Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib tablets contain erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4.HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is sparingly soluble in water and methanol. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.6 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-531-10</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (59651-531-10)  &gt; 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59651-0531-10</NDC11Code>
    <ProductNDC>59651-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Erlotinib</ProprietaryName>
    <NonProprietaryName>Erlotinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216342</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>ERLOTINIB HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Erlotinib tablets are a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1) , 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2) .</IndicationAndUsage>
    <Description>Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib tablets contain erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4.HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is sparingly soluble in water and methanol. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.6 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-531-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-531-01) </PackageDescription>
    <NDC11Code>68382-0531-01</NDC11Code>
    <ProductNDC>68382-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203553</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].</IndicationAndUsage>
    <Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below.                                      C23H27N3O7HCl             M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD &amp; C blue #2 aluminum lake; the 80 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 90 mg tablets contain D &amp; C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 115 mg tablets contain FD &amp; C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D &amp; C red #27 aluminum lake, D &amp; C yellow #10 aluminum lake and FD &amp; C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-531-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-531-05) </PackageDescription>
    <NDC11Code>68382-0531-05</NDC11Code>
    <ProductNDC>68382-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203553</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].</IndicationAndUsage>
    <Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below.                                      C23H27N3O7HCl             M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD &amp; C blue #2 aluminum lake; the 80 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 90 mg tablets contain D &amp; C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 115 mg tablets contain FD &amp; C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D &amp; C red #27 aluminum lake, D &amp; C yellow #10 aluminum lake and FD &amp; C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-531-06</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-531-06) </PackageDescription>
    <NDC11Code>68382-0531-06</NDC11Code>
    <ProductNDC>68382-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203553</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].</IndicationAndUsage>
    <Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below.                                      C23H27N3O7HCl             M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD &amp; C blue #2 aluminum lake; the 80 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 90 mg tablets contain D &amp; C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 115 mg tablets contain FD &amp; C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D &amp; C red #27 aluminum lake, D &amp; C yellow #10 aluminum lake and FD &amp; C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-531-10</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-531-10) </PackageDescription>
    <NDC11Code>68382-0531-10</NDC11Code>
    <ProductNDC>68382-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203553</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].</IndicationAndUsage>
    <Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below.                                      C23H27N3O7HCl             M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD &amp; C blue #2 aluminum lake; the 80 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 90 mg tablets contain D &amp; C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 115 mg tablets contain FD &amp; C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D &amp; C red #27 aluminum lake, D &amp; C yellow #10 aluminum lake and FD &amp; C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-531-30</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (68382-531-30)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68382-0531-30</NDC11Code>
    <ProductNDC>68382-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203553</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].</IndicationAndUsage>
    <Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below.                                      C23H27N3O7HCl             M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD &amp; C blue #2 aluminum lake; the 80 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 90 mg tablets contain D &amp; C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD &amp; C blue #2 aluminum lake and FD &amp; C red #40 aluminum lake; the 115 mg tablets contain FD &amp; C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D &amp; C red #27 aluminum lake, D &amp; C yellow #10 aluminum lake and FD &amp; C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0439-8</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71335-0439-8) </PackageDescription>
    <NDC11Code>71335-0439-08</NDC11Code>
    <ProductNDC>71335-0439</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketoconazole</ProprietaryName>
    <NonProprietaryName>Ketoconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19990615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075319</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>KETOCONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.</IndicationAndUsage>
    <Description>Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the following structural formula. Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-1849-8</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71335-1849-8) </PackageDescription>
    <NDC11Code>71335-1849-08</NDC11Code>
    <ProductNDC>71335-1849</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketoconazole</ProprietaryName>
    <NonProprietaryName>Ketoconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075912</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>KETOCONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.</IndicationAndUsage>
    <Description>Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the following structural formula. Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44g/mol. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72789-531-42</NDCCode>
    <PackageDescription>42 TABLET in 1 BOTTLE, PLASTIC (72789-531-42) </PackageDescription>
    <NDC11Code>72789-0531-42</NDC11Code>
    <ProductNDC>72789-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hcl</ProprietaryName>
    <NonProprietaryName>Metformin Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090564</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251009</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-531-01</NDCCode>
    <PackageDescription>200 AEROSOL, METERED in 1 CANISTER (76420-531-01) </PackageDescription>
    <NDC11Code>76420-0531-01</NDC11Code>
    <ProductNDC>76420-531</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20211130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207085</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.</IndicationAndUsage>
    <Description>The active component of albuterol sulfate inhalation aerosol is albuterol sulfate, USP racemic α 1 [( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta 2-adrenergic bronchodilator having the following chemical structure:. Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the molecular formula is (C 13H 21 NO 3) 2H 2SO 4. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate inhalation aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face. This product does not contain chlorofluorocarbons (CFCs) as the propellant.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-507-20</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (63323-507-20)  &gt; 10 mL in 1 VIAL (63323-507-01) </PackageDescription>
    <NDC11Code>63323-0507-20</NDC11Code>
    <ProductNDC>63323-507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20111014</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091404</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: : 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3) .</IndicationAndUsage>
    <Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-507-21</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (63323-507-21)  &gt; 10 mL in 1 VIAL (63323-507-19) </PackageDescription>
    <NDC11Code>63323-0507-21</NDC11Code>
    <ProductNDC>63323-507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20111014</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091404</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-03-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: : 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3) .</IndicationAndUsage>
    <Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-507-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (63323-507-25)  &gt; 10 mL in 1 VIAL (63323-507-43) </PackageDescription>
    <NDC11Code>63323-0507-25</NDC11Code>
    <ProductNDC>63323-507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20111014</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091404</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: : 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (  1.3)  .</IndicationAndUsage>
    <Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C 17H 25N 3O 5S3H 2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [ see Dosage and Administration ( 2.4) ].</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-508-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (63323-508-25)  &gt; 20 mL in 1 VIAL (63323-508-45) </PackageDescription>
    <NDC11Code>63323-0508-25</NDC11Code>
    <ProductNDC>63323-508</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20111026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091404</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: : 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (  1.3)  .</IndicationAndUsage>
    <Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C 17H 25N 3O 5S3H 2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [ see Dosage and Administration ( 2.4) ].</Description>
  </NDC>
</NDCList>