RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>61919-140-32</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (61919-140-32) </PackageDescription>
    <NDC11Code>61919-0140-32</NDC11Code>
    <ProductNDC>61919-140</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Viscous</ProprietaryName>
    <NonProprietaryName>Lidocaine Viscous</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL; TOPICAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088802</ApplicationNumber>
    <LabelerName>Direct RX</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine Viscous (Lidocaine Hydrochloride Oral Topical Solution USP) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
    <Description>Each mL contains. Lidocaine Hydrochloride . . . . . . . . . . 20 mg (2%). Inactive ingredients: flavoring, methylparaben, propylparaben, sodium carboxymethylcellulose, and sodium saccharin in an aqueous solution. Lidocaine Viscous (Lidocaine Hydrochloride Oral Topical Solution USP) contains a local anesthetic agent and is administered topically. Lidocaine hydrochloride is designated as 2-(Diethylamino)-2',6'-acetoxylidide monohydrochloride monohydrate, and has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-140-32</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, PLASTIC (16590-140-32)</PackageDescription>
    <NDC11Code>16590-0140-32</NDC11Code>
    <ProductNDC>16590-140</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL; TOPICAL</RouteName>
    <StartMarketingDate>19950710</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040014</ApplicationNumber>
    <LabelerName>STAT RX LLC USA</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
    <Description>DESCRIPTION. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6-dimethylphenyl)- , monohydrochloride and has the following structural formula. LIDOCAINE STRUCTURE IMAGE. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34. Each mL contains 20 mg of lidocaine HCl. In addition each mL contains the following inactive ingredients: Carboxymethylcellulose sodium, methylparaben, natural orange flavor, propylparaben, purified water, saccharin sodium. The pH is adjusted to 5.0 to 7.0 by means of hydrochloric acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53045-140-30</NDCCode>
    <PackageDescription>32 g in 1 BOTTLE (53045-140-30) </PackageDescription>
    <NDC11Code>53045-0140-30</NDC11Code>
    <ProductNDC>53045-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Avant</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20210122</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Dharma Research, Inc.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>6.4</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain associated with canker sores and minor dental procedures.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>53247-140-02</NDCCode>
    <PackageDescription>500 APPLICATOR in 1 CASE (53247-140-02)  / 32 g in 1 APPLICATOR</PackageDescription>
    <NDC11Code>53247-0140-02</NDC11Code>
    <ProductNDC>53247-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Meridian Unwrapped Antibacterial Deodorant</ProprietaryName>
    <NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20250101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Bob Barker Company Inc.</LabelerName>
    <SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For washing to decrease bacteria on skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69933-140-32</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, PLASTIC (69933-140-32) </PackageDescription>
    <NDC11Code>69933-0140-32</NDC11Code>
    <ProductNDC>69933-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alchemy Living Hand Sanitizer Coconut Fragrance</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230414</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Pearl World Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> To decrease bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71141-140-32</NDCCode>
    <PackageDescription>235 g in 1 BOTTLE, PLASTIC (71141-140-32) </PackageDescription>
    <NDC11Code>71141-0140-32</NDC11Code>
    <ProductNDC>71141-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Osmotic Laxative</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170331</StartMarketingDate>
    <EndMarketingDate>20211231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091077</ApplicationNumber>
    <LabelerName>Lidl US, LLC</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/17g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170331</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>72663-140-32</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (72663-140-32)  *  .9 mL in 1 POUCH *  .9 mL in 1 POUCH *  .9 mL in 1 POUCH *  .5 mL in 1 POUCH</PackageDescription>
    <NDC11Code>72663-0140-32</NDC11Code>
    <ProductNDC>72663-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Welly Superhero Supplies Kit</ProprietaryName>
    <NonProprietaryName>Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride, Hydrocortisone</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20190301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Welly Health PBC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>83986-140-32</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE, PUMP (83986-140-32) </PackageDescription>
    <NDC11Code>83986-0140-32</NDC11Code>
    <ProductNDC>83986-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Hand White Tea And Eucalyptus</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20221012</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>UpLift Brands LLC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61919-018-32</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (61919-018-32)</PackageDescription>
    <NDC11Code>61919-0018-32</NDC11Code>
    <ProductNDC>61919-018</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin Powder, For Suspension</NonProprietaryName>
    <DosageFormName>FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA061931</ApplicationNumber>
    <LabelerName>Direct RX</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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.Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below:1.1 Infections of the Ear, Nose, and Throat– due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.1.2 Infections of the Genitourinary Tract– due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.1.3 Infections of the Skin and Skin Structure– due to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.1.4 Infections of the Lower Respiratory Tract– due to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.1.5 Gonorrhea, Acute Uncomplicated (Ano-Genital and Urethral Infections in Males and Females)– due to Neisseria gonorrhoeae.Because of high rates of amoxicillin resistance, amoxicillin is not recommended for empiric treatment of gonorrhea. Amoxicillin use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.1.6 Triple Therapy for Helicobacter pylori With Clarithromycin and LansoprazoleAmoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.1.7 Dual Therapy for H. pylori With LansoprazoleAmoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
    <Description>Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. The structural formula is:Amoxicillin Capsules USPEach capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate.Inactive Ingredients: CAPSULES-DRUG PRODUCT: magnesium stearate, talc.CAPSULE SHELL AND PRINT CONSTITUENTS: black iron oxide, D&amp;C Yellow #10, D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40, FD&amp;C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac, titanium dioxide. In addition, the 500 mg capsule shell may also contain methylparaben, potassium hydroxide, propylparaben, and sodium lauryl sulfate; and the 250 mg capsule shell contains D&amp;C Red #28 and FD&amp;C Blue #1.Amoxicillin for Oral Suspension USPEach 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate.Inactive Ingredients: SUSPENSION: FD&amp;C Red #40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum.Amoxicillin Tablets USP (Chewable)Each chewable tablet, for oral administration, contains 125 mg or 250 mg of amoxicillin as the trihydrate.Inactive Ingredients: CHEWABLE TABLETS: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-049-32</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE (61919-049-32) </PackageDescription>
    <NDC11Code>61919-0049-32</NDC11Code>
    <ProductNDC>61919-049</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065234</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by S. pneumoniae and S. pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis. Skin and skin structure infections caused by staphylococci and/or streptococci. Bone infections caused by staphylococci and/or P. mirabilis. Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin for oral suspension and other antibacterial drugs, cephalexin for oral suspension 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic 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 C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-247-32</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (61919-247-32) </PackageDescription>
    <NDC11Code>61919-0247-32</NDC11Code>
    <ProductNDC>61919-247</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OROPHARYNGEAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040708</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150325</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine hydrochloride oral topical solution USP, 2% (viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
    <Description>Lidocaine hydrochloride oral topical solution USP, 2% (viscous) contains a local anesthetic agent and is administered topically. Lidocaine hydrochloride oral topical solution USP, 2% (viscous) contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34. COMPOSITION OF SOLUTION. Each mL contains 20 mg of lidocaine HCl, artificial cherry flavor, methylparaben, propylparaben, saccharin sodium, sodium carboxymethylcellulose, and sodium hydroxide in purified water. The pH is adjusted to 5.0 to 7.0 with hydrochloric acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-391-32</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE (61919-391-32) </PackageDescription>
    <NDC11Code>61919-0391-32</NDC11Code>
    <ProductNDC>61919-391</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Augmentin</ProprietaryName>
    <NonProprietaryName>Amox/clav.pot.oral Susp</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065191</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANIC ACID</SubstanceName>
    <StrengthNumber>400; 57</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The structural formula for Amoxicillin. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. The structural formula for Clavulanic acid. Inactive Ingredients:. Aspartame, colloidal silicon dioxide, HPMC 2910/ hypromellose 5 cP, silicon dioxide, succinic acid, xanthan gum, golden syrup flavor, orange flavor.  See PRECAUTIONS - Information for the Patient. Each 5 mL of reconstituted amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension contains 0.268 mEq of potassium. Each 5 mL of reconstituted amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension contains 0.143 mEq of potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-399-32</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (61919-399-32)</PackageDescription>
    <NDC11Code>61919-0399-32</NDC11Code>
    <ProductNDC>61919-399</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065334</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below. 1.1 Infections of the Ear, Nose, and Throatdue to Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. 1.2 Infections of the Genitourinary Tract. due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. 1.3 Infections of the Skin and Skin Structuredue to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. 1.4 Infections of the Lower Respiratory Tractdue to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. 1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections). due to Neisseria gonorrhoeae. Because of high rates of amoxicillin resistance, amoxicillin for oral suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin for oral suspension, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin. 1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole. Amoxicillin for oral suspension, USP, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 1.7 Dual Therapy for H. pylori with Lansoprazole. Amoxicillin for oral suspension, USP, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
    <Description>Formulationof amoxicillin for oral suspension, USP contains amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 200 mg or 400 mg anhydrous amoxicillin. Each 5 mL of the 200 mg and 400 mg reconstituted suspension contains 0.16 mEq (3.61 mg) of sodium; Inactive ingredients: sucrose, sodium citrate, sodium benzoate, edetate disodium, FD&amp;C Red No. 3, xanthan gum, bubble-gum flavor, and colloidal silicon dioxide. Close.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-401-32</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (61919-401-32) </PackageDescription>
    <NDC11Code>61919-0401-32</NDC11Code>
    <ProductNDC>61919-401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065334</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below. 1.1 Infections of the Ear, Nose, and Throatdue to Streptococcus species (α- and   β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.1.2 Infections of the Genitourinary Tract. due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.1.3 Infections of the Skin and Skin Structuredue to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.1.4 Infections of the Lower Respiratory Tractdue to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections). due to Neisseria gonorrhoeae. Because of high rates of amoxicillin resistance, amoxicillin for oral suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin for oral suspension, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole. Amoxicillin for oral suspension, USP, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.1.7 Dual Therapy for H. pylori with Lansoprazole. Amoxicillin for oral suspension, USP, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
    <Description>Formulationof amoxicillin for oral suspension, USP contains amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 200 mg or 400 mg anhydrous amoxicillin. Each 5 mL of the 200 mg and 400 mg reconstituted suspension contains 0.16 mEq (3.61 mg) of sodium; Inactive ingredients: sucrose, sodium citrate, sodium benzoate, edetate disodium, FD&amp;C Red No. 3, xanthan gum, bubble-gum flavor, and colloidal silicon dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-520-32</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE (61919-520-32) </PackageDescription>
    <NDC11Code>61919-0520-32</NDC11Code>
    <ProductNDC>61919-520</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL; TOPICAL</RouteName>
    <StartMarketingDate>20170222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040014</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
    <Description>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-, monohydrochloride and has the following structural formula. [Chemical Structure]. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-672-32</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (61919-672-32) </PackageDescription>
    <NDC11Code>61919-0672-32</NDC11Code>
    <ProductNDC>61919-672</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190402</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065378</ApplicationNumber>
    <LabelerName>DIRECTRX</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Infections of the Ear, Nose, and Throat. Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilusinfluenzae. 1.2 Infections of the Genitourinary Tract. Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. 1.3 Infections of the Skin and Skin Structure. Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. 1.4 Infections of the Lower Respiratory Tract. Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. 1.5 Helicobacter pylori Infection. Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 1.6 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. [Amoxicillin Chemical Structure]. The amoxicillin molecular formula is C16H19N3O5S  3H2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&amp;C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-798-32</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (61919-798-32) </PackageDescription>
    <NDC11Code>61919-0798-32</NDC11Code>
    <ProductNDC>61919-798</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin Oral Susp</ProprietaryName>
    <NonProprietaryName>Cephalexin Oral Susp</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190403</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065152</ApplicationNumber>
    <LabelerName>DIRECTRX</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>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 for oral suspension, USP and other antibacterial drugs, Cephalexin for oral suspension, USP 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, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. [image description]. C16H17N3O4SH2O M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: strawberry powder, methylcellulose, sodium lauryl sulfate, sucrose and FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-186-07</NDCCode>
    <PackageDescription>7 TABLET in 1 BOTTLE (61919-186-07) </PackageDescription>
    <NDC11Code>61919-0186-07</NDC11Code>
    <ProductNDC>61919-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201014</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040555</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N  HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-186-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (61919-186-14) </PackageDescription>
    <NDC11Code>61919-0186-14</NDC11Code>
    <ProductNDC>61919-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201014</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040555</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N  HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-244-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (61919-244-30)</PackageDescription>
    <NDC11Code>61919-0244-30</NDC11Code>
    <ProductNDC>61919-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hcl</ProprietaryName>
    <NonProprietaryName>Phentermine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160711</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091359</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61919-300-09</NDCCode>
    <PackageDescription>9 TABLET in 1 BLISTER PACK (61919-300-09)</PackageDescription>
    <NDC11Code>61919-0300-09</NDC11Code>
    <ProductNDC>61919-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate Tablet</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078327</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Sumatriptan tablets, USP are indicated for the acute treatment of migraine with or without aura in adults.Limitations of Use:Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, USP, reconsider the diagnosis of migraine before sumatriptan tablets, USP are administered to treat any subsequent attacks.Sumatriptan tablets, USP are not indicated for the prevention of migraine attacks.Safety and effectiveness of sumatriptan tablets, USP have not been established for cluster headache. .</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure:The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline.Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate. .</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-408-09</NDCCode>
    <PackageDescription>9 TABLET in 1 BOTTLE (61919-408-09)</PackageDescription>
    <NDC11Code>61919-0408-09</NDC11Code>
    <ProductNDC>61919-408</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Imitrex</ProprietaryName>
    <NonProprietaryName>Sumatriptan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160606</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078327</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-20</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Sumatriptan tablets, USP are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, USP, reconsider the diagnosis of migraine before sumatriptan tablets, USP are administered to treat any subsequent attacks. Sumatriptan tablets, USP are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan tablets, USP have not been established for cluster headache.</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure. Chemical Structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-557-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (61919-557-30) </PackageDescription>
    <NDC11Code>61919-0557-30</NDC11Code>
    <ProductNDC>61919-557</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190709</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087022</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N  HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-634-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61919-634-30)</PackageDescription>
    <NDC11Code>61919-0634-30</NDC11Code>
    <ProductNDC>61919-634</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091519</ApplicationNumber>
    <LabelerName>DirectRX</LabelerName>
    <SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>80; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP.Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.Add-On TherapyValsartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.Replacement TherapyValsartan and hydrochlorothiazide tablets, USP may be substituted for the titrated components.Initial TherapyValsartan and hydrochlorothiazide tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.The choice of valsartan and hydrochlorothiazide tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets, USP 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.Figure 1: Probability of Achieving Systolic Blood Pressure &lt;140 mmHg at Week 8Figure 2: Probability of Achieving Diastolic Blood Pressure &lt;90 mmHg at Week 8Figure 3: Probability of Achieving Systolic Blood Pressure &lt;130 mmHg at Week 8Figure 4: Probability of Achieving Diastolic Blood Pressure &lt;80 mmHg at Week 8For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide tablets, USP are combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula isValsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water.Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula isValsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg /12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg. The inactive ingredients of the film-coated tablets are microcrystalline cellulose, croscarmellose sodium, sodium dodecyl sulphate, hydroxypropylcellulose, silicified microcrystalline cellulose, low substituted hydroxypropylcellulose, magnesium stearate, polyvinyl alcohol-part. hydrolyzed, titanium dioxide, talc, polyethylene glycol, and iron oxide yellow. In addition, 80 mg /12.5 mg and 160 mg/12.5 mg tablets contain FD&amp;C red#40 /allura red AC aluminum lake, 80 mg /12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg and 320 mg/12.5 mg tablets contain iron oxide black, and 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg tablets contain iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-634-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-634-90)</PackageDescription>
    <NDC11Code>61919-0634-90</NDC11Code>
    <ProductNDC>61919-634</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
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    <DosageFormName>TABLET, FILM COATED</DosageFormName>
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    <StartMarketingDate>20150101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091519</ApplicationNumber>
    <LabelerName>DirectRX</LabelerName>
    <SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>80; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP.Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.Add-On TherapyValsartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.Replacement TherapyValsartan and hydrochlorothiazide tablets, USP may be substituted for the titrated components.Initial TherapyValsartan and hydrochlorothiazide tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.The choice of valsartan and hydrochlorothiazide tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets, USP 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.Figure 1: Probability of Achieving Systolic Blood Pressure &lt;140 mmHg at Week 8Figure 2: Probability of Achieving Diastolic Blood Pressure &lt;90 mmHg at Week 8Figure 3: Probability of Achieving Systolic Blood Pressure &lt;130 mmHg at Week 8Figure 4: Probability of Achieving Diastolic Blood Pressure &lt;80 mmHg at Week 8For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide tablets, USP are combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula isValsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water.Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula isValsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg /12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg. The inactive ingredients of the film-coated tablets are microcrystalline cellulose, croscarmellose sodium, sodium dodecyl sulphate, hydroxypropylcellulose, silicified microcrystalline cellulose, low substituted hydroxypropylcellulose, magnesium stearate, polyvinyl alcohol-part. hydrolyzed, titanium dioxide, talc, polyethylene glycol, and iron oxide yellow. In addition, 80 mg /12.5 mg and 160 mg/12.5 mg tablets contain FD&amp;C red#40 /allura red AC aluminum lake, 80 mg /12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg and 320 mg/12.5 mg tablets contain iron oxide black, and 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg tablets contain iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-790-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61919-790-30) </PackageDescription>
    <NDC11Code>61919-0790-30</NDC11Code>
    <ProductNDC>61919-790</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan/htcz</ProprietaryName>
    <NonProprietaryName>Valsartan/htcz</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203145</ApplicationNumber>
    <LabelerName>DIRECTRX</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
    <StrengthNumber>12.5; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy Valsartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy Valsartan and hydrochlorothiazide tablets, USP may be substituted for the titrated components. Initial Therapy Valsartan and hydrochlorothiazide tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)]provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets, USP 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. [figure-1]. Figure 1: Probability of Achieving Systolic Blood Pressure &lt;140 mmHg at Week 8. [figure-2]. Figure 2: Probability of Achieving Diastolic Blood Pressure &lt;90 mmHg at Week 8. [figure-3]. Figure 3: Probability of Achieving Systolic Blood Pressure &lt;130 mmHg at Week 8. [figure-4]. Figure 4: Probability of Achieving Diastolic Blood Pressure &lt;80 mmHg at Week 8 For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. [valsartan]. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. [hydrochlorothiazide]. Valsartan and hydrochlorothiazide tablets, USP, are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>61919-865-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (61919-865-30) </PackageDescription>
    <NDC11Code>61919-0865-30</NDC11Code>
    <ProductNDC>61919-865</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hcl C-iv</ProprietaryName>
    <NonProprietaryName>Phentermine Hcl C-iv</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091359</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N  HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
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    <PackageDescription>90 CAPSULE in 1 BOTTLE (61919-865-90) </PackageDescription>
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    <ProductNDC>61919-865</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hcl C-iv</ProprietaryName>
    <NonProprietaryName>Phentermine Hcl C-iv</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091359</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N  HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-099-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (61919-099-30)</PackageDescription>
    <NDC11Code>61919-0099-30</NDC11Code>
    <ProductNDC>61919-099</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075049</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>1.1 Major Depressive Disorder. Fluoxetine capsules USP are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see Clinical Studies (14.1)]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be reevaluated [see Dosage and Administration (2.1)]. 1.2 Obsessive Compulsive Disorder. Fluoxetine capsules USP are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. The effectiveness of fluoxetine capsules USP in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)]. 1.3 Bulimia Nervosa. Fluoxetine capsules USP are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. The physician who elects to use fluoxetine capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)]. 1.4 Panic Disorder. Fluoxetine capsules USP are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)]. The effectiveness of fluoxetine capsules USP in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)]. 1.5 Fluoxetine and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder. When using fluoxetine capsules USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®. Fluoxetine capsules USP and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine capsules USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. They are also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). They are designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and have the empirical formula of C17H18F3NOHCl. The molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule, for oral administration, contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine. The inactive ingredients are: corn starch, gelatin, magnesium stearate, pregelatinized starch, propylene glycol, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 10 and 20 mg capsules also contain D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, and pharmaceutical glaze; the 20 mg capsule also contains Black Iron Oxide, FD&amp;C Blue #2 Aluminum Lake, and FD&amp;C Red #40 Aluminum Lake; the 40 mg capsule also contains Red Iron Oxide, shellac, and Yellow Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-100-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (61919-100-30) </PackageDescription>
    <NDC11Code>61919-0100-30</NDC11Code>
    <ProductNDC>61919-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076001</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Major Depressive Disorder. Fluoxetine Capsules USP are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)]. 1.2 Obsessive Compulsive Disorder. Fluoxetine Capsules USP are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. The effectiveness of fluoxetine capsules USP in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)]. 1.3 Bulimia Nervosa. Fluoxetine Capsules USP are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. The physician who elects to use fluoxetine capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)]. 1.4 Panic Disorder. Fluoxetine Capsules USP are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)]. The effectiveness of fluoxetine capsules USP in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)]. 1.5 Fluoxetine Capsules USP and Olanzapine in Combination: Depressive Episodes Associated With Bipolar I Disorder. When using fluoxetine capsules USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®. Fluoxetine Capsules USP and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients. Fluoxetine Capsules USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.</IndicationAndUsage>
    <Description>Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor for oral administration. They are also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the following structural formula. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride, USP equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fluoxetine. In addition, the capsules also contain the following inactive ingredients: ammonium hydroxide, D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1 aluminum lake, gelatin, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, and titanium dioxide.</Description>
  </NDC>
</NDCList>