RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>62973-125-74</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (62973-125-74) </PackageDescription>
    <NDC11Code>62973-0125-74</NDC11Code>
    <ProductNDC>62973-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180127</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018965</ApplicationNumber>
    <LabelerName>Entreprises ImportFAB Inc.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0591-4039-74</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0591-4039-74)  / 125 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00591-4039-74</NDC11Code>
    <ProductNDC>0591-4039</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150828</StartMarketingDate>
    <EndMarketingDate>20250930</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021835</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150828</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Clobetasol Propionate Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>62973-126-73</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (62973-126-73) </PackageDescription>
    <NDC11Code>62973-0126-73</NDC11Code>
    <ProductNDC>62973-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naprosyn</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180127</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018965</ApplicationNumber>
    <LabelerName>Entreprises ImportFAB Inc.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0093-4125-74</NDCCode>
    <PackageDescription>200 mL in 1 BOTTLE (0093-4125-74) </PackageDescription>
    <NDC11Code>00093-4125-74</NDC11Code>
    <ProductNDC>0093-4125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Penicillin V Potassium</ProprietaryName>
    <NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA060456</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections—penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis)—Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium tablets, penicillin V potassium for oral solution, and other antibacterial drugs, penicillin V potassium tablets and penicillin V potassium for oral solution 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>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Each Penicillin V Potassium Tablet, USP contains penicillin V potassium equivalent to 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V. The inactive ingredients present are dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Each Penicillin V Potassium Tablet USP, 250 mg contains 0.71 mEq (27.9 mg) of potassium and each Penicillin V Potassium Tablet USP, 500 mg contains 1.43 mEq (55.8 mg) of potassium. Penicillin V Potassium for Oral Solution, USP is an off-white to pinkish colored powder, which when reconstituted as directed, yields a red colored solution with cherry flavor in which each 5 mL contains penicillin V potassium equivalent to 125 mg (200,000 units) or 250 mg (400,000 units) penicillin V. The inactive ingredients present are cherry flavor, FD&amp;C Red #40, saccharin sodium, sodium benzoate, and sucrose. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution USP, 125 mg (200,000 units) per 5 mL contains 0.36 mEq (13.9 mg) of potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq (27.9 mg) of potassium. Monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0093-4127-74</NDCCode>
    <PackageDescription>200 mL in 1 BOTTLE (0093-4127-74) </PackageDescription>
    <NDC11Code>00093-4127-74</NDC11Code>
    <ProductNDC>0093-4127</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Penicillin V Potassium</ProprietaryName>
    <NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA060456</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections—penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis)—Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium tablets, penicillin V potassium for oral solution, and other antibacterial drugs, penicillin V potassium tablets and penicillin V potassium for oral solution 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>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Each Penicillin V Potassium Tablet, USP contains penicillin V potassium equivalent to 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V. The inactive ingredients present are dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Each Penicillin V Potassium Tablet USP, 250 mg contains 0.71 mEq (27.9 mg) of potassium and each Penicillin V Potassium Tablet USP, 500 mg contains 1.43 mEq (55.8 mg) of potassium. Penicillin V Potassium for Oral Solution, USP is an off-white to pinkish colored powder, which when reconstituted as directed, yields a red colored solution with cherry flavor in which each 5 mL contains penicillin V potassium equivalent to 125 mg (200,000 units) or 250 mg (400,000 units) penicillin V. The inactive ingredients present are cherry flavor, FD&amp;C Red #40, saccharin sodium, sodium benzoate, and sucrose. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution USP, 125 mg (200,000 units) per 5 mL contains 0.36 mEq (13.9 mg) of potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq (27.9 mg) of potassium. Monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0093-4175-74</NDCCode>
    <PackageDescription>200 mL in 1 BOTTLE (0093-4175-74) </PackageDescription>
    <NDC11Code>00093-4175-74</NDC11Code>
    <ProductNDC>0093-4175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062703</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria in adults and pediatric patients aged one year and older: 1 Respiratory tract infection (1.1), 2 Otitis media (1.2), 3 Skin and skin structure infections (1.3), 4 Bone infections (1.4), 5 Genitourinary tract infections (1.5) .</IndicationAndUsage>
    <Description>Cephalexin for oral suspension, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin, USP has the following structural formula.                                                                                                            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: cherry mixed fruit flavor (artificial flavors, maltodextrin, and modified corn starch), FD&amp;C Red No. 40, silicon dioxide, sodium benzoate, sugar (fruit granulated), and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0093-4177-74</NDCCode>
    <PackageDescription>200 mL in 1 BOTTLE (0093-4177-74) </PackageDescription>
    <NDC11Code>00093-4177-74</NDC11Code>
    <ProductNDC>0093-4177</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062703</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria in adults and pediatric patients aged one year and older: 1 Respiratory tract infection (1.1), 2 Otitis media (1.2), 3 Skin and skin structure infections (1.3), 4 Bone infections (1.4), 5 Genitourinary tract infections (1.5) .</IndicationAndUsage>
    <Description>Cephalexin for oral suspension, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin, USP has the following structural formula.                                                                                                            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: cherry mixed fruit flavor (artificial flavors, maltodextrin, and modified corn starch), FD&amp;C Red No. 40, silicon dioxide, sodium benzoate, sugar (fruit granulated), and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0440-7100-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0440-7100-30)</PackageDescription>
    <NDC11Code>00440-7100-30</NDC11Code>
    <ProductNDC>0440-7100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19880225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062884</ApplicationNumber>
    <LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in  the conditions listed below. Infections of the ear, nose and throat- due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract- due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure- due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp. or E. coli. Infections of the lower respiratory tract- due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections)- due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy: Amoxicillin/clarithromycin/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 l-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. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.). Dual Therapy: Amoxicillin/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. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.). 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 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. Indicated surgical procedures should be performed.</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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S  3H2O, and the molecular weight is 419.45. Amoxicillin capsules, tablets and powder for oral suspension are intended for oral administration. Amoxicillin Capsules provide amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Amoxicillin Capsules, USP also contain Magnesium Stearate, NF; Sodium Lauryl Sulfate, NF. The capsule shell contains D&amp;C red No. 33; FD&amp;C blue No. 1; FD&amp;C red No. 40; FD&amp;C yellow No. 6; Gelatin, NF; Sodium Lauryl Sulfate, NF Titanium Dioxide, USP. Each 250 mg capsule contains up to 0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium. Amoxicillin Tablets provide amoxicillin trihydrate equivalent to 875 mg. In addition each tablet contains the following inactive ingredients: Sodium Starch Glycolate, NF; Pregelatinized Starch, NF; Colloidal Silicon Dioxide, NF; Povidone, USP; Magnesium Stearate, NF; Polyvinyl Alcohol, USP; Titanium Dioxide, USP; Talc, NF; Polyethylene Glycol, NF and Lecithin, NF. Each tablet contains up to 0.032 mEq (0.74 mg) of Sodium. Amoxicillin for Oral Suspension is a dry powder and when reconstituted according to directions, contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin per 5 mL. Amoxicillin for Oral Suspension, USP also contains flavors; casing color (FD&amp;C red No. 40 and FD&amp;C yellow No. 6); Microcrystalline Cellulose and Carboxymethylcellulose Sodium, NF; Colloidal Silicon Dioxide, NF; Sodium Citrate, USP; Sodium Propionate, NF; Sucrose NF. Each 5 mL of the 125 mg reconstituted suspension contains up to 0.209 mEq (4.80 mg) of sodium; each 5 mL of the 250 mg reconstituted suspension contains up to 0.417 mEq (9.60 mg) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7292-61</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7292-61)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7292-61</NDC11Code>
    <ProductNDC>0904-7292</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <EndMarketingDate>20260630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212861</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .</IndicationAndUsage>
    <Description>The Potassium Chloride Extended-Release Tablets USP, 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 15 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Its molecular weight is 74.55 g/mole. Potassium chloride, USP occurs as a white to off-white, crystalline, granular powder. It is freely soluble in water and insoluble in alcohol. Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethyl cellulose, microcrystalline cellulose and triethyl citrate. Meets USP Dissolution Test 7.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-7293-61</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7293-61)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-7293-61</NDC11Code>
    <ProductNDC>0904-7293</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <EndMarketingDate>20261130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212861</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .</IndicationAndUsage>
    <Description>The Potassium Chloride Extended-Release Tablets USP, 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 15 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Its molecular weight is 74.55 g/mole. Potassium chloride, USP occurs as a white to off-white, crystalline, granular powder. It is freely soluble in water and insoluble in alcohol. Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethyl cellulose, microcrystalline cellulose and triethyl citrate. Meets USP Dissolution Test 7.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-091-74</NDCCode>
    <PackageDescription>100 TABLET in 1 CARTON (13668-091-74) </PackageDescription>
    <NDC11Code>13668-0091-74</NDC11Code>
    <ProductNDC>13668-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090865</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>15370-306-30</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (15370-306-30)  / 1.185 g in 1 POUCH</PackageDescription>
    <NDC11Code>15370-0306-30</NDC11Code>
    <ProductNDC>15370-306</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pokonza</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251209</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208019</ApplicationNumber>
    <LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.125</StrengthNumber>
    <StrengthUnit>g/1.185g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>POKONZA® (Potasium Chloride for Oral Solution, USP) is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of POKONZA® (Potassium Chloride for Oral Solution, USP) is a light pink to orange powder containing: 1 10 mEq: contains 0.75 g of potassium chloride, USP, which is equivalent to potassium 10 mEq and chloride 10 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&amp;C Yellow #6, natural and artificial orange flavor, and sucralose., 2 15 mEq: contains 1.185 g of potassium chloride, USP, which is equivalent to potassium 15 mEq and chloride 15 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&amp;C Yellow #6, natural and artificial orange flavor, and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>15370-306-60</NDCCode>
    <PackageDescription>60 POUCH in 1 CARTON (15370-306-60)  / 1.85 g in 1 POUCH</PackageDescription>
    <NDC11Code>15370-0306-60</NDC11Code>
    <ProductNDC>15370-306</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pokonza</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251209</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208019</ApplicationNumber>
    <LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.125</StrengthNumber>
    <StrengthUnit>g/1.185g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>POKONZA® (Potasium Chloride for Oral Solution, USP) is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of POKONZA® (Potassium Chloride for Oral Solution, USP) is a light pink to orange powder containing: 1 10 mEq: contains 0.75 g of potassium chloride, USP, which is equivalent to potassium 10 mEq and chloride 10 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&amp;C Yellow #6, natural and artificial orange flavor, and sucralose., 2 15 mEq: contains 1.185 g of potassium chloride, USP, which is equivalent to potassium 15 mEq and chloride 15 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&amp;C Yellow #6, natural and artificial orange flavor, and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-125-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (16590-125-30)</PackageDescription>
    <NDC11Code>16590-0125-30</NDC11Code>
    <ProductNDC>16590-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075682</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
    <Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-125-40</NDCCode>
    <PackageDescription>40 TABLET in 1 BOTTLE (16590-125-40)</PackageDescription>
    <NDC11Code>16590-0125-40</NDC11Code>
    <ProductNDC>16590-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075682</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
    <Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-125-50</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (16590-125-50)</PackageDescription>
    <NDC11Code>16590-0125-50</NDC11Code>
    <ProductNDC>16590-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075682</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
    <Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-125-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (16590-125-60)</PackageDescription>
    <NDC11Code>16590-0125-60</NDC11Code>
    <ProductNDC>16590-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075682</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
    <Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-125-71</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (16590-125-71)</PackageDescription>
    <NDC11Code>16590-0125-71</NDC11Code>
    <ProductNDC>16590-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075682</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
    <Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-125-72</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (16590-125-72)</PackageDescription>
    <NDC11Code>16590-0125-72</NDC11Code>
    <ProductNDC>16590-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075682</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
    <Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-125-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (16590-125-90)</PackageDescription>
    <NDC11Code>16590-0125-90</NDC11Code>
    <ProductNDC>16590-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075682</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
    <Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>25000-080-74</NDCCode>
    <PackageDescription>288 TABLET, FILM COATED in 1 BOTTLE (25000-080-74) </PackageDescription>
    <NDC11Code>25000-0080-74</NDC11Code>
    <ProductNDC>25000-080</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen 250 Mg And Ibuprofen 125 Mg</ProprietaryName>
    <NonProprietaryName>Acetaminophen 250 Mg And Ibuprofen 125 Mg Tablets</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230711</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216994</ApplicationNumber>
    <LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
    <SubstanceName>ACETAMINOPHEN; IBUPROFEN</SubstanceName>
    <StrengthNumber>250; 125</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230711</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>28595-240-35</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (28595-240-35) </PackageDescription>
    <NDC11Code>28595-0240-35</NDC11Code>
    <ProductNDC>28595-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Augmentin</ProprietaryName>
    <NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
    <DosageFormName>FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050575</ApplicationNumber>
    <LabelerName>Allegis Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
    <StrengthNumber>125; 31.25</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>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AUGMENTIN is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis. , 3 Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis. , 4 Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. , 5 Urinary Tract Infections - caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. .</IndicationAndUsage>
    <Description>. AUGMENTIN 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 C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-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:. 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 C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. AUGMENTIN for Oral Suspension. : 1 125 mg/31.25 mg: Following constitution, each 5 mL of oral suspension contains 125 mg of amoxicillin as the trihydrate, and 31.25 mg of clavulanic acid (equivalent to 37.23 mg of clavulanate potassium). , 2 250 mg/62.5 mg: Following constitution, each 5 mL of oral suspension contains 250 mg of amoxicillin as the trihydrate, and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). .</Description>
  </NDC>
  <NDC>
    <NDCCode>28595-240-36</NDCCode>
    <PackageDescription>150 mL in 1 BOTTLE (28595-240-36) </PackageDescription>
    <NDC11Code>28595-0240-36</NDC11Code>
    <ProductNDC>28595-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Augmentin</ProprietaryName>
    <NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
    <DosageFormName>FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050575</ApplicationNumber>
    <LabelerName>Allegis Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
    <StrengthNumber>125; 31.25</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>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AUGMENTIN is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis. , 3 Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis. , 4 Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. , 5 Urinary Tract Infections - caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. .</IndicationAndUsage>
    <Description>. AUGMENTIN 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 C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-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:. 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 C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. AUGMENTIN for Oral Suspension. : 1 125 mg/31.25 mg: Following constitution, each 5 mL of oral suspension contains 125 mg of amoxicillin as the trihydrate, and 31.25 mg of clavulanic acid (equivalent to 37.23 mg of clavulanate potassium). , 2 250 mg/62.5 mg: Following constitution, each 5 mL of oral suspension contains 250 mg of amoxicillin as the trihydrate, and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). .</Description>
  </NDC>
  <NDC>
    <NDCCode>41442-150-02</NDCCode>
    <PackageDescription>125 mL in 1 BOTTLE, PUMP (41442-150-02)</PackageDescription>
    <NDC11Code>41442-0150-02</NDC11Code>
    <ProductNDC>41442-150</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Complexion Perfector Bb Spf20 Medium</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130318</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Omorovicza Kozmetikai Kft.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>62; 74</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Protects from UVA/B sunrays.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43598-130-74</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (43598-130-74)  / 16 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>43598-0130-74</NDC11Code>
    <ProductNDC>43598-130</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone Sodium Succinate</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20220324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212396</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/16mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5665-0</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5665-0) </PackageDescription>
    <NDC11Code>50090-5665-00</NDC11Code>
    <ProductNDC>50090-5665</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212861</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .</IndicationAndUsage>
    <Description>The Potassium Chloride Extended-Release Tablets USP, 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 15 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Its molecular weight is 74.55 g/mole. Potassium chloride, USP occurs as a white to off-white, crystalline, granular powder. It is freely soluble in water and insoluble in alcohol. Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethyl cellulose, microcrystalline cellulose and triethyl citrate. Meets USP Dissolution Test 7.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5665-1</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5665-1) </PackageDescription>
    <NDC11Code>50090-5665-01</NDC11Code>
    <ProductNDC>50090-5665</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212861</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .</IndicationAndUsage>
    <Description>The Potassium Chloride Extended-Release Tablets USP, 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 15 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Its molecular weight is 74.55 g/mole. Potassium chloride, USP occurs as a white to off-white, crystalline, granular powder. It is freely soluble in water and insoluble in alcohol. Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethyl cellulose, microcrystalline cellulose and triethyl citrate. Meets USP Dissolution Test 7.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5665-2</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5665-2) </PackageDescription>
    <NDC11Code>50090-5665-02</NDC11Code>
    <ProductNDC>50090-5665</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212861</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .</IndicationAndUsage>
    <Description>The Potassium Chloride Extended-Release Tablets USP, 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 15 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Its molecular weight is 74.55 g/mole. Potassium chloride, USP occurs as a white to off-white, crystalline, granular powder. It is freely soluble in water and insoluble in alcohol. Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethyl cellulose, microcrystalline cellulose and triethyl citrate. Meets USP Dissolution Test 7.</Description>
  </NDC>
  <NDC>
    <NDCCode>54288-125-10</NDCCode>
    <PackageDescription>100 POUCH in 1 CARTON (54288-125-10)  / 1.58 g in 1 POUCH (54288-125-01) </PackageDescription>
    <NDC11Code>54288-0125-10</NDC11Code>
    <ProductNDC>54288-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride For Oral Solution</ProprietaryName>
    <NonProprietaryName>Potassium Chloride For Oral Solution</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212183</ApplicationNumber>
    <LabelerName>BPI Labs LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/1.58g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&amp;C Yellow #6, natural and artificial orange flavor, and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>54288-125-30</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (54288-125-30)  / 1.58 g in 1 POUCH (54288-125-01) </PackageDescription>
    <NDC11Code>54288-0125-30</NDC11Code>
    <ProductNDC>54288-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride For Oral Solution</ProprietaryName>
    <NonProprietaryName>Potassium Chloride For Oral Solution</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212183</ApplicationNumber>
    <LabelerName>BPI Labs LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/1.58g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&amp;C Yellow #6, natural and artificial orange flavor, and sucralose.</Description>
  </NDC>
</NDCList>