RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>43386-917-10</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-10) </PackageDescription>
    <NDC11Code>43386-0917-10</NDC11Code>
    <ProductNDC>43386-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206347</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/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>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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, 2     hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a, 3     lower dose of diuretic, which may be sufficient without leading to hypokalemia., 4 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized, 5     patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
    <Description>Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K 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. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP 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 outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-917-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-01) </PackageDescription>
    <NDC11Code>43386-0917-01</NDC11Code>
    <ProductNDC>43386-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206347</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/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>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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, 2     hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a, 3     lower dose of diuretic, which may be sufficient without leading to hypokalemia., 4 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized, 5     patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
    <Description>Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K 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. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP 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 outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-917-04</NDCCode>
    <PackageDescription>400 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-04) </PackageDescription>
    <NDC11Code>43386-0917-04</NDC11Code>
    <ProductNDC>43386-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206347</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/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>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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, 2     hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a, 3     lower dose of diuretic, which may be sufficient without leading to hypokalemia., 4 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized, 5     patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
    <Description>Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K 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. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP 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 outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-917-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-05) </PackageDescription>
    <NDC11Code>43386-0917-05</NDC11Code>
    <ProductNDC>43386-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206347</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/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>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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, 2     hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a, 3     lower dose of diuretic, which may be sufficient without leading to hypokalemia., 4 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized, 5     patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
    <Description>Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K 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. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP 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 outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-917-09</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-09) </PackageDescription>
    <NDC11Code>43386-0917-09</NDC11Code>
    <ProductNDC>43386-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206347</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/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>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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, 2     hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a, 3     lower dose of diuretic, which may be sufficient without leading to hypokalemia., 4 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized, 5     patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
    <Description>Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K 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. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP 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 outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>10577-917-10</NDCCode>
    <PackageDescription>15 kg in 1 DRUM (10577-917-10) </PackageDescription>
    <NDC11Code>10577-0917-10</NDC11Code>
    <ProductNDC>10577-917</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Enclomiphene Citrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20141126</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>PCAS</LabelerName>
    <SubstanceName>ENCLOMIPHENE CITRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>26-NOV-14</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>21130-917-09</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 PACKAGE (21130-917-09)  &gt; 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21130-0917-09</NDC11Code>
    <ProductNDC>21130-917</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Severe Congestion And Cold</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength/ Multi-symptom</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130407</StartMarketingDate>
    <EndMarketingDate>20220626</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Better Living Brands, LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 200; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130407</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220626</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>23155-917-41</NDCCode>
    <PackageDescription>10 VIAL in 1 PACKAGE (23155-917-41)  / 2 g in 1 VIAL (23155-917-31) </PackageDescription>
    <NDC11Code>23155-0917-41</NDC11Code>
    <ProductNDC>23155-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ampicillin</ProprietaryName>
    <NonProprietaryName>Ampicillin Injection</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20250131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090354</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/2g</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP 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>Ampicillin for Injection, USP the monosodium salt of [2S-[2α, 5α, 6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
  </NDC>
  <NDC>
    <NDCCode>24470-917-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24470-917-10) </PackageDescription>
    <NDC11Code>24470-0917-10</NDC11Code>
    <ProductNDC>24470-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ergotamine Tartrate And Caffeine</ProprietaryName>
    <NonProprietaryName>Ergotamine Tartrate And Caffeine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040590</ApplicationNumber>
    <LabelerName>Cintex Services, LLC</LabelerName>
    <SubstanceName>ERGOTAMINE TARTRATE; CAFFEINE</SubstanceName>
    <StrengthNumber>1; 100</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Ergotamine Derivative [EPC], Ergotamines [CS], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ergotamine tartrate and caffeine tablets are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called “histaminic cephalalgia.”.</IndicationAndUsage>
    <Description>Each tablet for oral administration contains 1 mg ergotamine tartrate, USP, and 100 mg caffeine, USP. ERGOTAMINE TARTRATE. (C 33H 35N 5O 5) 2 C 4H 6O 6. M.W. 1313.41. Ergotaman-3’,6’,18-trione, 12’-hydroxy-2’-methyl-5’-(phenyl-methyl)-, (5’α), [R-(R*, R*)]-2,3-dihydroxy-butanedioate (2:1) (salt). CAFFEINE. C 8H 10N 4O 2 (anhydrous). M.W. 194.19. 1 H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-. Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Film coating includes the following ingredients: macrogol/PEG 3350, polyvinyl alcohol, purified water, talc, titanium dioxide, FD&amp;C blue #2 aluminum lake, FD&amp;C red #40 aluminum lake, and FD&amp;C yellow #5 tartrazine aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>37803-917-10</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE (37803-917-10)</PackageDescription>
    <NDC11Code>37803-0917-10</NDC11Code>
    <ProductNDC>37803-917</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Itraconazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150707</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Apotheca Supply Inc.</LabelerName>
    <SubstanceName>ITRACONAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>40032-917-10</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-917-10) </PackageDescription>
    <NDC11Code>40032-0917-10</NDC11Code>
    <ProductNDC>40032-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206347</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/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>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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>Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K 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. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP 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 outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-917-58</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (43598-917-58)  / 1 mL in 1 VIAL, SINGLE-DOSE (43598-917-11) </PackageDescription>
    <NDC11Code>43598-0917-58</NDC11Code>
    <ProductNDC>43598-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carboprost Tromethamine</ProprietaryName>
    <NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20200204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211941</ApplicationNumber>
    <LabelerName>Dr. Reddy�s Laboratories Inc.</LabelerName>
    <SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carboprost tromethamine injection, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion. 1. Failure of expulsion of the fetus during the course of treatment by another method;. 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;. 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;. 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.</IndicationAndUsage>
    <Description>Carboprost tromethamine injection, USP an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine injection, USP is the established name for the active ingredient carboprost tromethamine, USP. Four other chemical names are. 1. (15S)-15-methyl prostaglandin F2α tromethamine salt. 2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2- amino-2-(hydroxymethyl)-1,3-propanediol. 3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt. 4. (15S)-15-methyl PGF2α-THAM. The structural formula is represented below. The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine, USP is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating. Carboprost tromethamine, USP dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of carboprost tromethamine injection, USP contains carboprost tromethamine, USP equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.</Description>
  </NDC>
  <NDC>
    <NDCCode>52125-917-10</NDCCode>
    <PackageDescription>6 TABLET, FILM COATED in 1 BLISTER PACK (52125-917-10)</PackageDescription>
    <NDC11Code>52125-0917-10</NDC11Code>
    <ProductNDC>52125-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160423</StartMarketingDate>
    <EndMarketingDate>20170301</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076255</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>54575-917-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-917-10)</PackageDescription>
    <NDC11Code>54575-0917-10</NDC11Code>
    <ProductNDC>54575-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Red Cedar Pollen</ProprietaryName>
    <NonProprietaryName>Juniperus Virginiana Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>JUNIPERUS VIRGINIANA POLLEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>59556-917-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (59556-917-01)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59556-0917-01</NDC11Code>
    <ProductNDC>59556-917</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Loratadine</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210810</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213294</ApplicationNumber>
    <LabelerName>Strides Pharma Inc</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes , 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60687-917-14</NDCCode>
    <PackageDescription>4 TRAY in 1 CASE (60687-917-14)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-917-51)  / 30 mL in 1 CUP, UNIT-DOSE (60687-917-45) </PackageDescription>
    <NDC11Code>60687-0917-14</NDC11Code>
    <ProductNDC>60687-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose</ProprietaryName>
    <NonProprietaryName>Lactulose</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260816</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090503</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
    <Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O- β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular weight is 342 .30. It is freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-917-64</NDCCode>
    <PackageDescription>4 TRAY in 1 CASE (60687-917-64)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-917-50)  / 15 mL in 1 CUP, UNIT-DOSE (60687-917-44) </PackageDescription>
    <NDC11Code>60687-0917-64</NDC11Code>
    <ProductNDC>60687-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose</ProprietaryName>
    <NonProprietaryName>Lactulose</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260816</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090503</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
    <Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O- β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular weight is 342 .30. It is freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-917-76</NDCCode>
    <PackageDescription>10 TRAY in 1 CASE (60687-917-76)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-917-51)  / 30 mL in 1 CUP, UNIT-DOSE (60687-917-45) </PackageDescription>
    <NDC11Code>60687-0917-76</NDC11Code>
    <ProductNDC>60687-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose</ProprietaryName>
    <NonProprietaryName>Lactulose</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260816</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090503</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
    <Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O- β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular weight is 342 .30. It is freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>66651-917-14</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (66651-917-14) </PackageDescription>
    <NDC11Code>66651-0917-14</NDC11Code>
    <ProductNDC>66651-917</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170724</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>HIKAL LIMITED</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-03-23</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>24-JUL-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>68382-917-77</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (68382-917-77)  / 10 TABLET in 1 BLISTER PACK (68382-917-30) </PackageDescription>
    <NDC11Code>68382-0917-77</NDC11Code>
    <ProductNDC>68382-917</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone</ProprietaryName>
    <NonProprietaryName>Methylprednisolone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206751</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions:.</IndicationAndUsage>
    <Description>Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol   (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below. C22H30O5. Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-022-31</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (43386-022-31)  / 10 TABLET in 1 BLISTER PACK (43386-022-30) </PackageDescription>
    <NDC11Code>43386-0022-31</NDC11Code>
    <ProductNDC>43386-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Linezolid</ProprietaryName>
    <NonProprietaryName>Linezolid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207526</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>LINEZOLID</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections (1.5). Limitations of Use (1.6): 1 Linezolid Tablets are not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled, 3 clinical trials.</IndicationAndUsage>
    <Description>Linezolid Tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4- morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid tablets for oral administration contain 600 mg linezolid, supplied as white, oval, film-coated tablets, debossed with "n 022" on one side and plain on other side. Inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidine, magnesium stearate, titanium dioxide, polydextrose, hypromellose, triacetin, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-088-31</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (43386-088-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (43386-088-30) </PackageDescription>
    <NDC11Code>43386-0088-31</NDC11Code>
    <ProductNDC>43386-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207371</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-089-31</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (43386-089-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (43386-089-30) </PackageDescription>
    <NDC11Code>43386-0089-31</NDC11Code>
    <ProductNDC>43386-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207371</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-356-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43386-356-10) </PackageDescription>
    <NDC11Code>43386-0356-10</NDC11Code>
    <ProductNDC>43386-356</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206245</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-357-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43386-357-10) </PackageDescription>
    <NDC11Code>43386-0357-10</NDC11Code>
    <ProductNDC>43386-357</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206245</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>7.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-358-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43386-358-10) </PackageDescription>
    <NDC11Code>43386-0358-10</NDC11Code>
    <ProductNDC>43386-358</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206245</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-490-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43386-490-10) </PackageDescription>
    <NDC11Code>43386-0490-10</NDC11Code>
    <ProductNDC>43386-490</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170224</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204407</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 2.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*.  (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*.  (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*.  (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*.  (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl                                        MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2                                       MW 151.16.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-491-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43386-491-10) </PackageDescription>
    <NDC11Code>43386-0491-10</NDC11Code>
    <ProductNDC>43386-491</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170224</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204407</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*.  (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*.  (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*.  (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*.  (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl                                        MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2                                       MW 151.16.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-492-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43386-492-10) </PackageDescription>
    <NDC11Code>43386-0492-10</NDC11Code>
    <ProductNDC>43386-492</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170224</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204407</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 7.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*.  (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*.  (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*.  (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*.  (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl                                        MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2                                       MW 151.16.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-493-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43386-493-10) </PackageDescription>
    <NDC11Code>43386-0493-10</NDC11Code>
    <ProductNDC>43386-493</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170224</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204407</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*.  (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*.  (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*.  (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*.  (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl                                        MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2                                       MW 151.16.</Description>
  </NDC>
</NDCList>