RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>80425-0501-7</NDCCode>
    <PackageDescription>180 TABLET, COATED in 1 BOTTLE (80425-0501-7) </PackageDescription>
    <NDC11Code>80425-0501-07</NDC11Code>
    <ProductNDC>80425-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-0501-01</NDCCode>
    <PackageDescription>7 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01)  / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00074-0501-01</NDC11Code>
    <ProductNDC>0074-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vyalev</ProprietaryName>
    <NonProprietaryName>Foscarbidopa/foslevodopa</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20220412</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216962</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>FOSCARBIDOPA; FOSLEVODOPA</SubstanceName>
    <StrengthNumber>12; 240</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD).</IndicationAndUsage>
    <Description>VYALEV injection is a solution that is a combination of foscarbidopa (carbidopa-4´-monophosphate) and foslevodopa (levodopa-4´-monophosphate). Foscarbidopa and foslevodopa are prodrugs that undergo enzymatic bioconversion via intrinsic alkaline phosphatase to carbidopa and levodopa, respectively, in vivo. Foscarbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white to light yellow powder, freely soluble in aqueous media, with a molecular weight of 306.21 g/mol anhydrous. It is designated chemically as (2S)-2-hydrazinyl-3-[3-hydroxy-4-(phosphonooxy)phenyl]-2-methylpropanoic acid trihydrate. Its empirical formula is C10H15N2O7P (anhydrous basis), and its structural formula is:. Foslevodopa, an aromatic amino acid, is a white to off-white powder, freely soluble in aqueous media, with a molecular weight of 277.17 g/mol. It is designated chemically as (2S)-2-amino-3-[3-hydroxy-4-(phosphonooxy)phenyl] propanoic acid. Its empirical formula is C9H12NO7P, and its structural formula is. VYALEV (foscarbidopa and foslevodopa) injection is a sterile, preservative-free solution for subcutaneous infusion. VYALEV is supplied in a 10 mL single-dose glass vial that contains 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL).  VYALEV may contain sodium hydroxide and/or hydrochloric acid to adjust the pH to approximately 7.4.</Description>
  </NDC>
  <NDC>
    <NDCCode>15631-0501-7</NDCCode>
    <PackageDescription>10000 TABLET in 1 CONTAINER (15631-0501-7)</PackageDescription>
    <NDC11Code>15631-0501-07</NDC11Code>
    <ProductNDC>15631-0501</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Abies Canadensis</ProprietaryName>
    <NonProprietaryName>Abies Canadensis</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151229</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>TSUGA CANADENSIS BARK</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>80425-0501-1</NDCCode>
    <PackageDescription>15 TABLET, COATED in 1 BOTTLE (80425-0501-1) </PackageDescription>
    <NDC11Code>80425-0501-01</NDC11Code>
    <ProductNDC>80425-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0501-2</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE (80425-0501-2) </PackageDescription>
    <NDC11Code>80425-0501-02</NDC11Code>
    <ProductNDC>80425-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0501-3</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (80425-0501-3) </PackageDescription>
    <NDC11Code>80425-0501-03</NDC11Code>
    <ProductNDC>80425-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0501-4</NDCCode>
    <PackageDescription>90 TABLET, COATED in 1 BOTTLE (80425-0501-4) </PackageDescription>
    <NDC11Code>80425-0501-04</NDC11Code>
    <ProductNDC>80425-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0501-5</NDCCode>
    <PackageDescription>120 TABLET, COATED in 1 BOTTLE (80425-0501-5) </PackageDescription>
    <NDC11Code>80425-0501-05</NDC11Code>
    <ProductNDC>80425-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0501-6</NDCCode>
    <PackageDescription>40 TABLET, COATED in 1 BOTTLE (80425-0501-6) </PackageDescription>
    <NDC11Code>80425-0501-06</NDC11Code>
    <ProductNDC>80425-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0501-8</NDCCode>
    <PackageDescription>240 TABLET, COATED in 1 BOTTLE (80425-0501-8) </PackageDescription>
    <NDC11Code>80425-0501-08</NDC11Code>
    <ProductNDC>80425-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0004-7</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (80425-0004-7) </PackageDescription>
    <NDC11Code>80425-0004-07</NDC11Code>
    <ProductNDC>80425-0004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220914</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065253</ApplicationNumber>
    <LabelerName>ADVANCED RX PHARMACY OF TENNESSEE, LLC</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Respiratory Tract Infections. Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media. Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. 1.3 Skin and Skin Structure Infections. Cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes. 1.4 Bone Infections. Cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections. Cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. 1.6 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, FD&amp;C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0121-7</NDCCode>
    <PackageDescription>6 CAPSULE in 1 BOTTLE (80425-0121-7) </PackageDescription>
    <NDC11Code>80425-0121-07</NDC11Code>
    <ProductNDC>80425-0121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090836</ApplicationNumber>
    <LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1 INDICATIONS &amp; USAGE. 1.1 Respiratory Tract Infections. Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media. Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. 1.3 Skin and Skin Structure Infections. Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes. 1.4 Bone Infections. Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections. Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. 1.6 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16 H 17 N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD &amp; C Blue No. 1, D &amp; C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD &amp; C Red No. 40; 333 mg and 750 mg Capsules contains FD &amp; C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0159-7</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE (80425-0159-7) </PackageDescription>
    <NDC11Code>80425-0159-07</NDC11Code>
    <ProductNDC>80425-0159</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hcl</ProprietaryName>
    <NonProprietaryName>Tramadol Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075964</ApplicationNumber>
    <LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</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>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS AND USAGE. Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated or are not expected to be tolerated.  Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP 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. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0274-7</NDCCode>
    <PackageDescription>180 TABLET, COATED in 1 BOTTLE (80425-0274-7) </PackageDescription>
    <NDC11Code>80425-0274-07</NDC11Code>
    <ProductNDC>80425-0274</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208708</ApplicationNumber>
    <LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2024-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]. Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline 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. Tramadol Hydrochloride Tablets, USP 50 mg and Tramadol Hydrochloride Tablets, USP 100 mg contain 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0276-7</NDCCode>
    <PackageDescription>180 TABLET, COATED in 1 BOTTLE (80425-0276-7) </PackageDescription>
    <NDC11Code>80425-0276-07</NDC11Code>
    <ProductNDC>80425-0276</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208708</ApplicationNumber>
    <LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline 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. Tramadol Hydrochloride Tablets, USP 50 mg and Tramadol Hydrochloride Tablets, USP 100 mg contain 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0367-1</NDCCode>
    <PackageDescription>8 POUCH in 1 BOX (80425-0367-1)  / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH</PackageDescription>
    <NDC11Code>80425-0367-01</NDC11Code>
    <ProductNDC>80425-0367</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trubrexa</ProprietaryName>
    <NonProprietaryName>Lidocaine And Capsaicin</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20231127</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</LabelerName>
    <SubstanceName>CAPSAICIN; LIDOCAINE</SubstanceName>
    <StrengthNumber>.00025; .0475</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Trubrexa TMTransdermal Patch is indicated in adults over the age of 12 years old for the treatment of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.</IndicationAndUsage>
    <Description>Trubrexa TMTransdermal Patch is comprised of an adhesive material containing 4.75% lidocaine and 0.025% capsaicin. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TMTransdermal Patch logo. 4 patches are included in each pouch bag. The inactive ingredients include: Arnica, Magnesium, Polyacrylate, Vegan Glycerol, and Water. Trubrexa TMTransdermal Patch is Latex Free, Paraben Free, and Vegan.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0388-1</NDCCode>
    <PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (80425-0388-1) </PackageDescription>
    <NDC11Code>80425-0388-01</NDC11Code>
    <ProductNDC>80425-0388</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Llevofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240522</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077652</ApplicationNumber>
    <LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240522</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levofloxacin  is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1, 12.4). : 1 Pneumonia: Nosocomial ( 1.1) and Community Acquired ( 1.2, 1.3) , 2 Skin and Skin Structure Infections (SSSI): Complicated ( 1.4) and Uncomplicated ( 1.5) , 3 Chronic bacterial prostatitis ( 1.6) , 4 Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7) , 5 Plague in adult and pediatric patients ( 1.8) , 6 Urinary Tract Infections (UTI): Complicated ( 1.9, 1.10) and Uncomplicated ( 1.12) , 7 Acute Pyelonephritis ( 1.11) , 8 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13) , 9 Acute Bacterial Sinusitis ( 1.14) .</IndicationAndUsage>
    <Description>Levofloxacin tablets are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C 18H 20FN 3O 4 ½ H 2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely solublein this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely solublein this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitrochelation potential has the following formation order:. Al +3&gt; Cu +2&gt; Zn +2&gt; Mg +2&gt; Ca +2. Each levofloxacin tablet, USP intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and  titanium dioxide. The product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0443-1</NDCCode>
    <PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (80425-0443-1) </PackageDescription>
    <NDC11Code>80425-0443-01</NDC11Code>
    <ProductNDC>80425-0443</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210420</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil Tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
    <Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round, pale yellow to yellow tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0548-7</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-7) </PackageDescription>
    <NDC11Code>80425-0548-07</NDC11Code>
    <ProductNDC>80425-0548</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250827</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211825</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride, USP is 299.98. Tramadol hydrochloride is a white or almost white, crystalline powder. It is freely soluble in water and in methanol, very slightly  soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are pale yellow in color. Inactive ingredients in the tablet are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0588-7</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE (80425-0588-7) </PackageDescription>
    <NDC11Code>80425-0588-07</NDC11Code>
    <ProductNDC>80425-0588</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075968</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</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>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1)] , reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. Tramadol hydrochloride tablets contain 50 mg of tramadol hydrochloride (equivalent to 43.9 mg of tramadol) and are white in color. Inactive ingredients in the tablet are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry white, sodium starch glycolate. The opadry white contains HPMC 2910/Hypromellose 3 mPas and 6 mPas, Macrogol, Polysorbate 80 and Titanium Dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0501-15</NDCCode>
    <PackageDescription>30 PATCH in 1 CARTON (0078-0501-15)  / 24 h in 1 PATCH (0078-0501-61) </PackageDescription>
    <NDC11Code>00078-0501-15</NDC11Code>
    <ProductNDC>0078-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Exelon</ProprietaryName>
    <NonProprietaryName>Rivastigmine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20070706</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022083</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>RIVASTIGMINE</SubstanceName>
    <StrengthNumber>4.6</StrengthNumber>
    <StrengthUnit>mg/24h</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20070706</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EXELON PATCH is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2).</IndicationAndUsage>
    <Description>EXELON PATCH (rivastigmine transdermal system) contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. EXELON PATCH is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the EXELON PATCH. Excipients within the formulation include acrylic copolymer, poly (butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0501-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0501-01) </PackageDescription>
    <NDC11Code>00378-0501-01</NDC11Code>
    <ProductNDC>0378-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075768</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>2.5; 6.25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
    <Description>Bisoprolol fumarate and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as 1-[[α-(2-Isopropoxyethoxy)-4-toly]oxy]-3-(isopropylamino)-2-propanol fumarate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablet, for oral administration, contains one of the following combinations of bisoprolol fumarate/hydrochlorothiazide: 2.5 mg/6.25 mg, 5 mg/6.25 mg or 10 mg/6.25 mg. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. In addition, the 2.5 mg/6.25 mg tablets contain FD&amp;C Yellow No. 6 Aluminum Lake and the 5 mg/6.25 mg tablets contain FD&amp;C Blue No. 2 Aluminum Lake and FD&amp;C Yellow No. 6 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0501-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0501-05) </PackageDescription>
    <NDC11Code>00378-0501-05</NDC11Code>
    <ProductNDC>0378-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075768</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>2.5; 6.25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
    <Description>Bisoprolol fumarate and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as 1-[[α-(2-Isopropoxyethoxy)-4-toly]oxy]-3-(isopropylamino)-2-propanol fumarate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablet, for oral administration, contains one of the following combinations of bisoprolol fumarate/hydrochlorothiazide: 2.5 mg/6.25 mg, 5 mg/6.25 mg or 10 mg/6.25 mg. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. In addition, the 2.5 mg/6.25 mg tablets contain FD&amp;C Yellow No. 6 Aluminum Lake and the 5 mg/6.25 mg tablets contain FD&amp;C Blue No. 2 Aluminum Lake and FD&amp;C Yellow No. 6 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0501-98</NDCCode>
    <PackageDescription>20 VIAL, SINGLE-DOSE in 1 TRAY (0409-0501-98)  / 50 mL in 1 VIAL, SINGLE-DOSE (0409-0501-97) </PackageDescription>
    <NDC11Code>00409-0501-98</NDC11Code>
    <ProductNDC>0409-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propofol</ProprietaryName>
    <NonProprietaryName>Propofol</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077908</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
    <Description>Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white to slight off-white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of egg lecithin (12 mg/mL), 1.5 mg of benzyl alcohol (1.5 mg/mL), 0.7 mg of sodium benzoate (0.7 mg/mL), and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0498-4383-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0498-4383-01)  *  .9 g in 1 PACKET *  500 mL in 1 CONTAINER *  .4 mL in 1 POUCH (0498-0143-04)  *  118 mL in 1 BOTTLE, PLASTIC (59898-420-12)  *  .9 g in 1 PACKET *  1.4 mL in 1 PACKET (0498-0501-00)  *  .5 g in 1 PACKET (0498-0750-36)  *  118 mL in 1 BOTTLE (0498-0100-02) </PackageDescription>
    <NDC11Code>00498-4383-01</NDC11Code>
    <ProductNDC>0498-4383</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>4383 First Aid Kit</ProprietaryName>
    <NonProprietaryName>4383 First Aid</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20180913</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Honeywell Safety Products USA, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180913</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs. pH adjusted with Hydrochloric Acid NF pH: 5.0 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154 0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The PIC Container is PVC-free and DEHP-free. Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The PIC Container is PVC-free and DEHP-free.</Description>
  </NDC>
  <NDC>
    <NDCCode>0498-4384-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0498-4384-01)  *  1.4 mL in 1 PACKET (0498-0501-00)  *  500 mL in 1 CONTAINER *  .4 mL in 1 POUCH (0498-0143-04)  *  118 mL in 1 BOTTLE, PLASTIC (59898-420-12)  *  .9 g in 1 PACKET *  .5 g in 1 PACKET (0498-0750-36)  *  118 mL in 1 BOTTLE (0498-0100-02)  *  .9 g in 1 PACKET (0498-0800-34) </PackageDescription>
    <NDC11Code>00498-4384-01</NDC11Code>
    <ProductNDC>0498-4384</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>4384 First Aid Kit</ProprietaryName>
    <NonProprietaryName>4384 First Aid</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20180913</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Honeywell Safety Products USA, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180913</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs. pH adjusted with Hydrochloric Acid NF pH: 5.0 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154 0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The PIC Container is PVC-free and DEHP-free. Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The PIC Container is PVC-free and DEHP-free.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-501-43</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (16729-501-43)  / 4 mL in 1 VIAL, SINGLE-DOSE (16729-501-64) </PackageDescription>
    <NDC11Code>16729-0501-43</NDC11Code>
    <ProductNDC>16729-501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20210421</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070017</ApplicationNumber>
    <LabelerName>Accord Healthcare, Inc.</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210421</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema:Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.</IndicationAndUsage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide USP is a white to slightly yellowish, odorless crystalline powder. It is practically insoluble in water, freely soluble in acetone, in dimethyl formamide, and in solutions of alkali hydroxides, soluble in methanol, sparingly soluble in alcohol, slightly soluble in ether, very slightly soluble in chloroform. The structural formula is as follows.             Molecular Formula:                          Molecular Weight:             C 12H 11ClN 2O 5S                             330.74. Each mL contains: Furosemide USP 10 mg, Water for Injection q.s., Sodium Chloride 7.4 mg (for isotonicity), Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
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    <PackageDescription>1 BLISTER PACK in 1 CARTON (24090-501-07)  &gt; 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>24090-0501-07</NDC11Code>
    <ProductNDC>24090-501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tirosint</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100401</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021924</ApplicationNumber>
    <LabelerName>Akrimax Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-30</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
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    <NDCCode>24090-501-84</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (24090-501-84)  &gt; 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>24090-0501-84</NDC11Code>
    <ProductNDC>24090-501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tirosint</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100401</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021924</ApplicationNumber>
    <LabelerName>Akrimax Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-30</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
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    <PackageDescription>2 BLISTER PACK in 1 CARTON (24090-501-94)  &gt; 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>24090-0501-94</NDC11Code>
    <ProductNDC>24090-501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tirosint</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100401</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021924</ApplicationNumber>
    <LabelerName>Akrimax Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-30</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
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