RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>16571-738-06</NDCCode>
    <PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-738-06) </PackageDescription>
    <NDC11Code>16571-0738-06</NDC11Code>
    <ProductNDC>16571-738</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205956</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>425</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.</IndicationAndUsage>
    <Description>Propafenone Hydrochloride Extended-Release Capsules, USP are an antiarrhythmic drug supplied in extended- release capsules of 225, 325, and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3∙HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone Hydrochloride Extended-Release Capsules, USP are filled with white to off white round, biconvex mini tablets containing propafenone and the following inactive ingredients: hypromellose and magnesium stearate. Each capsule contains titanium dioxide and gelatin. In addition, the 225 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Red No. 3, the 325 mg capsule contains FD&amp;C Blue No. 2, and the 425 mg capsule contains FD&amp;C Green No. 3. The black imprinting ink consists of black iron oxide (ferrosoferric oxide), propylene glycol, potassium hydroxide, shellac, and ammonium hydroxide. USP Dissolution Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-738-50</NDCCode>
    <PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-738-50) </PackageDescription>
    <NDC11Code>16571-0738-50</NDC11Code>
    <ProductNDC>16571-738</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205956</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>425</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.</IndicationAndUsage>
    <Description>Propafenone Hydrochloride Extended-Release Capsules, USP are an antiarrhythmic drug supplied in extended- release capsules of 225, 325, and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3∙HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone Hydrochloride Extended-Release Capsules, USP are filled with white to off white round, biconvex mini tablets containing propafenone and the following inactive ingredients: hypromellose and magnesium stearate. Each capsule contains titanium dioxide and gelatin. In addition, the 225 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Red No. 3, the 325 mg capsule contains FD&amp;C Blue No. 2, and the 425 mg capsule contains FD&amp;C Green No. 3. The black imprinting ink consists of black iron oxide (ferrosoferric oxide), propylene glycol, potassium hydroxide, shellac, and ammonium hydroxide. USP Dissolution Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>11673-738-06</NDCCode>
    <PackageDescription>177 mL in 1 BOTTLE (11673-738-06) </PackageDescription>
    <NDC11Code>11673-0738-06</NDC11Code>
    <ProductNDC>11673-738</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Maximum Strength Fast Mucus Relief</ProprietaryName>
    <ProprietaryNameSuffix>Severe Congestion And Cough</ProprietaryNameSuffix>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151110</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20; 400; 10</StrengthNumber>
    <StrengthUnit>mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleepnasal congestion due to a cold.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-738-06</NDCCode>
    <PackageDescription>180 mL in 1 BOTTLE, PLASTIC (21130-738-06) </PackageDescription>
    <NDC11Code>21130-0738-06</NDC11Code>
    <ProductNDC>21130-738</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Maximum Strength Severe Congestion And Cough</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, And Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200930</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>SAFEWAY</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20; 400; 10</StrengthNumber>
    <StrengthUnit>mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleepnasal congestion due to a cold.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>30142-738-06</NDCCode>
    <PackageDescription>180 mL in 1 BOTTLE, PLASTIC (30142-738-06) </PackageDescription>
    <NDC11Code>30142-0738-06</NDC11Code>
    <ProductNDC>30142-738</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kroger Maximum Strength Severe Congestion And Cough</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, And Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200903</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>KROGER COMPANY</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20; 400; 10</StrengthNumber>
    <StrengthUnit>mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200903</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleepnasal congestion due to a cold.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>37835-738-06</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (37835-738-06) </PackageDescription>
    <NDC11Code>37835-0738-06</NDC11Code>
    <ProductNDC>37835-738</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aspirin</ProprietaryName>
    <NonProprietaryName>Aspirin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960210</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Bi-Mart</LabelerName>
    <SubstanceName>ASPIRIN</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-10-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves: 1 pain and fever of colds, 2 toothache, 3 menstrual pain, 4 muscle pain, 5 headache, 6 minor pain of arthritis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41163-738-06</NDCCode>
    <PackageDescription>180 mL in 1 BOTTLE (41163-738-06)</PackageDescription>
    <NDC11Code>41163-0738-06</NDC11Code>
    <ProductNDC>41163-738</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Maximum Strength Mucus Relief Severe Congestion And Cough</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170907</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>SuperValu Inc.,</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20; 400; 10</StrengthNumber>
    <StrengthUnit>mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2017-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleepnasal congestion due to a cold.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42602-003-06</NDCCode>
    <PackageDescription>738 L in 1 CYLINDER (42602-003-06) </PackageDescription>
    <NDC11Code>42602-0003-06</NDC11Code>
    <ProductNDC>42602-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrous Oxide</ProprietaryName>
    <NonProprietaryName>Nitrous Oxide</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20080901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206009</ApplicationNumber>
    <LabelerName>Norco, Inc</LabelerName>
    <SubstanceName>NITROUS OXIDE</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43063-738-06</NDCCode>
    <PackageDescription>6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-06) </PackageDescription>
    <NDC11Code>43063-0738-06</NDC11Code>
    <ProductNDC>43063-738</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203458</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic  T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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>Metronidazole tablets, USP 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-738-20</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-20)  &gt; 20 mL in 1 VIAL, MULTI-DOSE (63323-738-06) </PackageDescription>
    <NDC11Code>63323-0738-20</NDC11Code>
    <ProductNDC>63323-738</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20010719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075709</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: : 1 Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than 8 weeks. , 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. , 3 Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. , 4 Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). , 5 Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). .</IndicationAndUsage>
    <Description>The active ingredient in Famotidine Injection, USP is a histamine H2–receptor antagonist. Famotidine is [1-Amino-3-[[[2- [(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propylidene] sulfamide. Its structural formula is:. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Famotidine Injection, USP is supplied as a sterile concentrated solution for intravenous injection. Each mL of the solution contains 10 mg of famotidine and the following inactive ingredients: L-aspartic acid 4 mg, mannitol 20 mg, Water for Injection q.s. 1 mL and benzyl alcohol 0 .9 % added as preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>73926-738-06</NDCCode>
    <PackageDescription>192 BOTTLE, PLASTIC in 1 NOT APPLICABLE (73926-738-06)  / 3785 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>73926-0738-06</NDC11Code>
    <ProductNDC>73926-738</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sterno Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethanol, Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200407</StartMarketingDate>
    <EndMarketingDate>20231231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>STERNO PRODUCTS, LLC</LabelerName>
    <SubstanceName>ALCOHOL; ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>63.5; 2.8</StrengthNumber>
    <StrengthUnit>mL/100mL; mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200407</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>16571-112-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-112-06) </PackageDescription>
    <NDC11Code>16571-0112-06</NDC11Code>
    <ProductNDC>16571-112</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
    <NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210959</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the.  Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1):Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
    <Description>Hydroxychloroquine is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate USP is a white or off-white to slightly yellowish color powder, freely soluble in water and practically insoluble in ethanol.  Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: lactose monohydrate, magnesium stearate, maize starch and povidone. The film coating contains polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-126-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-126-06) </PackageDescription>
    <NDC11Code>16571-0126-06</NDC11Code>
    <ProductNDC>16571-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204721</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white 03A18585 [hypromellose, purified stearic acid, titanium dioxide, microcrystalline cellulose].</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-127-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-127-06) </PackageDescription>
    <NDC11Code>16571-0127-06</NDC11Code>
    <ProductNDC>16571-127</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204721</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
    <Description>Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white 03A18585 [hypromellose, purified stearic acid, titanium dioxide, microcrystalline cellulose].</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-201-06</NDCCode>
    <PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06) </PackageDescription>
    <NDC11Code>16571-0201-06</NDC11Code>
    <ProductNDC>16571-201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080819</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077863</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
    <Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2                           M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-202-06</NDCCode>
    <PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-06) </PackageDescription>
    <NDC11Code>16571-0202-06</NDC11Code>
    <ProductNDC>16571-202</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090066</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
    <Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2                           M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-215-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)</PackageDescription>
    <NDC11Code>16571-0215-06</NDC11Code>
    <ProductNDC>16571-215</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tindazole</ProprietaryName>
    <NonProprietaryName>Tinidazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131009</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202489</ApplicationNumber>
    <LabelerName>Pack Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>TINIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: 1 Trichomoniasis (1.1), 2 Giardiasis: in patients age 3 and older (1.2), 3 Amebiasis: in patients age 3 and older (1.3), 4 Bacterial Vaginosis: in non-pregnant, adult women (1.4, 8.1).</IndicationAndUsage>
    <Description>Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure. Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, triacetin, FD&amp;C Red 40, FD&amp;C Yellow 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-654-06</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (16571-654-06) </PackageDescription>
    <NDC11Code>16571-0654-06</NDC11Code>
    <ProductNDC>16571-654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zafirlukast</ProprietaryName>
    <NonProprietaryName>Zafirlukast</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220825</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204928</ApplicationNumber>
    <LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ZAFIRLUKAST</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220825</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zafirlukast Tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.</IndicationAndUsage>
    <Description>Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is:. The empirical formula is: C31H33N3O6S. Zafirlukast, an off white to light pink color powder, is practically insoluble in water. It is freely soluble in tetrahydrofuran, dimethylsulfoxide and acetone. Zafirlukast Tablets are supplied as 10 and 20 mg tablets for oral administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-655-06</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (16571-655-06) </PackageDescription>
    <NDC11Code>16571-0655-06</NDC11Code>
    <ProductNDC>16571-655</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zafirlukast</ProprietaryName>
    <NonProprietaryName>Zafirlukast Tablets</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220825</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204928</ApplicationNumber>
    <LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ZAFIRLUKAST</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220825</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zafirlukast Tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.</IndicationAndUsage>
    <Description>Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is:. The empirical formula is: C31H33N3O6S. Zafirlukast, an off white to light pink color powder, is practically insoluble in water. It is freely soluble in tetrahydrofuran, dimethylsulfoxide and acetone. Zafirlukast Tablets are supplied as 10 and 20 mg tablets for oral administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-659-06</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (16571-659-06) </PackageDescription>
    <NDC11Code>16571-0659-06</NDC11Code>
    <ProductNDC>16571-659</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Selegiline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Selegiline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190402</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206803</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>SELEGILINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Selegiline capsules, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).</IndicationAndUsage>
    <Description>Selegiline hydrochloride, USP is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.The chemical name is: (R)-(-)-N α-Dimethyl-N-2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The molecular formula is C13H17N·HCl and the structural formula is as follows. Each capsule, for oral administration contains 5 mg of selegiline hydrochloride. In addition, each capsules contains the following inactive ingredients: anhydrous citric acid, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, and magnesium stearate. The capsule shell contains gelatin, D&amp;C Red # 28, FD&amp;C Blue # 1, FD&amp;C Yellow #6 and titanium dioxide and are imprinted with black ink. The ink contains the inactive ingredients: ammonium hydroxide, n-butyl alcohol, isopropyl alcohol, iron oxide black, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-705-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-705-06) </PackageDescription>
    <NDC11Code>16571-0705-06</NDC11Code>
    <ProductNDC>16571-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078462</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3) .</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5­-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (maize), sodium starch glycolate, and titanium dioxide. In addition, the 50 mg and 100 mg tablets contain iron oxide yellow and 200 mg tablet contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-706-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-706-06) </PackageDescription>
    <NDC11Code>16571-0706-06</NDC11Code>
    <ProductNDC>16571-706</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078462</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3) .</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5­-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (maize), sodium starch glycolate, and titanium dioxide. In addition, the 50 mg and 100 mg tablets contain iron oxide yellow and 200 mg tablet contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-707-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-707-06) </PackageDescription>
    <NDC11Code>16571-0707-06</NDC11Code>
    <ProductNDC>16571-707</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078462</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3) .</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5­-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (maize), sodium starch glycolate, and titanium dioxide. In addition, the 50 mg and 100 mg tablets contain iron oxide yellow and 200 mg tablet contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-708-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-708-06) </PackageDescription>
    <NDC11Code>16571-0708-06</NDC11Code>
    <ProductNDC>16571-708</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078462</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3) .</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5­-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (maize), sodium starch glycolate, and titanium dioxide. In addition, the 50 mg and 100 mg tablets contain iron oxide yellow and 200 mg tablet contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-721-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-721-06) </PackageDescription>
    <NDC11Code>16571-0721-06</NDC11Code>
    <ProductNDC>16571-721</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091388</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-­piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water.Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets.Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-736-06</NDCCode>
    <PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-736-06) </PackageDescription>
    <NDC11Code>16571-0736-06</NDC11Code>
    <ProductNDC>16571-736</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205956</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>225</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.</IndicationAndUsage>
    <Description>Propafenone Hydrochloride Extended-Release Capsules, USP are an antiarrhythmic drug supplied in extended- release capsules of 225, 325, and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3∙HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone Hydrochloride Extended-Release Capsules, USP are filled with white to off white round, biconvex mini tablets containing propafenone and the following inactive ingredients: hypromellose and magnesium stearate. Each capsule contains titanium dioxide and gelatin. In addition, the 225 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Red No. 3, the 325 mg capsule contains FD&amp;C Blue No. 2, and the 425 mg capsule contains FD&amp;C Green No. 3. The black imprinting ink consists of black iron oxide (ferrosoferric oxide), propylene glycol, potassium hydroxide, shellac, and ammonium hydroxide. USP Dissolution Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-737-06</NDCCode>
    <PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-737-06) </PackageDescription>
    <NDC11Code>16571-0737-06</NDC11Code>
    <ProductNDC>16571-737</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205956</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.</IndicationAndUsage>
    <Description>Propafenone Hydrochloride Extended-Release Capsules, USP are an antiarrhythmic drug supplied in extended- release capsules of 225, 325, and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3∙HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone Hydrochloride Extended-Release Capsules, USP are filled with white to off white round, biconvex mini tablets containing propafenone and the following inactive ingredients: hypromellose and magnesium stearate. Each capsule contains titanium dioxide and gelatin. In addition, the 225 mg capsule contains D&amp;C Yellow No. 10 and FD&amp;C Red No. 3, the 325 mg capsule contains FD&amp;C Blue No. 2, and the 425 mg capsule contains FD&amp;C Green No. 3. The black imprinting ink consists of black iron oxide (ferrosoferric oxide), propylene glycol, potassium hydroxide, shellac, and ammonium hydroxide. USP Dissolution Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-784-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-784-06) </PackageDescription>
    <NDC11Code>16571-0784-06</NDC11Code>
    <ProductNDC>16571-784</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gemfibrozil</ProprietaryName>
    <NonProprietaryName>Gemfibrozil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202726</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>GEMFIBROZIL</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I).The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
    <Description>Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, colloidal silicon dioxide, hypromellose, low substituted hydroxypropyl cellulose, low viscosity hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, polysorbate, pregelatinized starch (maize), and titanium dioxide. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.35; practically insoluble in water, soluble in alcohol, in methanol and in chloroform. The melting point is 58° to 61°C. Gemfibrozil USP is a white or almost white, waxy crystalline solid.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-790-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-790-06) </PackageDescription>
    <NDC11Code>16571-0790-06</NDC11Code>
    <ProductNDC>16571-790</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <EndMarketingDate>20260131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078993</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20090115</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
    <Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water.  In addition 250 mg contains FD&amp;C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&amp;C Yellow #6/sunset yellow FCF aluminum lake, FD&amp;C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-806-06</NDCCode>
    <PackageDescription>1 CARTON in 1 KIT (16571-806-06)  / 1 BOTTLE, GLASS in 1 CARTON / 60 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>16571-0806-06</NDC11Code>
    <ProductNDC>16571-806</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sirolimus</ProprietaryName>
    <NonProprietaryName>Sirolimus</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215116</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>SIROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1).Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
    <Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in chloroform, acetone, and acetonitrile. Sirolimus oral solution is available for administration as an oral solution containing 1 mg/mL sirolimus. The inactive ingredients in sirolimus oral solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Sirolimus oral solution contains 1.5% – 2.5% ethanol.</Description>
  </NDC>
</NDCList>