RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>62559-195-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-195-05) </PackageDescription>
    <NDC11Code>62559-0195-05</NDC11Code>
    <ProductNDC>62559-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077396</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)1,3- dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:. C15H10Cl2N2O2                              M.W. 321.16. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-195-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (62559-195-01) </PackageDescription>
    <NDC11Code>62559-0195-01</NDC11Code>
    <ProductNDC>62559-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077396</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)1,3- dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:. C15H10Cl2N2O2                              M.W. 321.16. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-195-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (62559-195-10) </PackageDescription>
    <NDC11Code>62559-0195-10</NDC11Code>
    <ProductNDC>62559-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077396</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)1,3- dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:. C15H10Cl2N2O2                              M.W. 321.16. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>10825-002-05</NDCCode>
    <PackageDescription>195 L in 1 DEWAR (10825-002-05)</PackageDescription>
    <NDC11Code>10825-0002-05</NDC11Code>
    <ProductNDC>10825-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19740101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Northern Welding Supply</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>13107-195-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13107-195-05) </PackageDescription>
    <NDC11Code>13107-0195-05</NDC11Code>
    <ProductNDC>13107-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090083</ApplicationNumber>
    <LabelerName>Aurolife Pharma, LLC</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: : 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3) .</IndicationAndUsage>
    <Description>Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&amp;C blue #2/indigo carmine aluminum lake, D&amp;C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>49884-195-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (49884-195-05)</PackageDescription>
    <NDC11Code>49884-0195-05</NDC11Code>
    <ProductNDC>49884-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nabumetone</ProprietaryName>
    <NonProprietaryName>Nabumetone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078671</ApplicationNumber>
    <LabelerName>Par Pharmaceutical Inc.</LabelerName>
    <SubstanceName>NABUMETONE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-09</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>50563-195-05</NDCCode>
    <PackageDescription>20 BOTTLE in 1 CARTON (50563-195-05)  &gt; 500 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>50563-0195-05</NDC11Code>
    <ProductNDC>50563-195</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clean Hands Antibacterial Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200503</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200503</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ Hand sanitizer to help decrease bacteria on the skin ■When water, soap &amp; towel are not available. ■Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54340-195-05</NDCCode>
    <PackageDescription>6 BOTTLE, PUMP in 1 CARTON (54340-195-05)  / 221 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>54340-0195-05</NDC11Code>
    <ProductNDC>54340-195</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dial Foaming Antibacterial Defense Spring Water</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Henkel Corporation</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwasing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63376-195-05</NDCCode>
    <PackageDescription>100 g in 1 BAG (63376-195-05)</PackageDescription>
    <NDC11Code>63376-0195-05</NDC11Code>
    <ProductNDC>63376-195</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Estriol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140806</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Suzhou Pharmaceutical Technology Co.,Ltd</LabelerName>
    <SubstanceName>ESTRIOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>64220-195-05</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (64220-195-05)</PackageDescription>
    <NDC11Code>64220-0195-05</NDC11Code>
    <ProductNDC>64220-195</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Efavirenz</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20160826</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>EFAVIRENZ</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68428-195-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-195-05) </PackageDescription>
    <NDC11Code>68428-0195-05</NDC11Code>
    <ProductNDC>68428-195</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ambra Grisea</ProprietaryName>
    <NonProprietaryName>Ambergris</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100429</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>AMBERGRIS</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68462-195-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (68462-195-05) </PackageDescription>
    <NDC11Code>68462-0195-05</NDC11Code>
    <ProductNDC>68462-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pravastatin Sodium</ProprietaryName>
    <NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077987</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pravastatin sodium tablets are indicated:1.To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD).2.To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.3.As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.4.As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH).5.As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Pravastatin Sodium Tablets, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (&gt;300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin Sodium Tablets, USP for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.48 mg, 18.97 mg, 37.94 mg and 75.88 mg of pravastatin, respectively. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&amp;C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&amp;C yellow no. 10 aluminum lake and FD&amp;C blue no. 1 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>72865-195-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-195-05) </PackageDescription>
    <NDC11Code>72865-0195-05</NDC11Code>
    <ProductNDC>72865-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214422</ApplicationNumber>
    <LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
    <Description>Potassium Chloride Extended-Release Tablets, 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 K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 15 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq K 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 extended-release tablets 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, granular powder or as colorless crystals. 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 tablets 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 tablets begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP. FDA approved sample preparation in the assay differs from USP test.</Description>
  </NDC>
  <NDC>
    <NDCCode>85593-195-05</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE (85593-195-05) </PackageDescription>
    <NDC11Code>85593-0195-05</NDC11Code>
    <ProductNDC>85593-195</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zxiqm Wart Remover</ProprietaryName>
    <NonProprietaryName>Zxiqm Wart Remover</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Guangzhou ChuanMa International Trading Co.,Ltd.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>85766-195-05</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (85766-195-05)  / 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>85766-0195-05</NDC11Code>
    <ProductNDC>85766-195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone Acetate</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE</RouteName>
    <StartMarketingDate>20211115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201835</ApplicationNumber>
    <LabelerName>Sportpharm LLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE ACETATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of Methylprednisolone Acetate Injectable Suspension, sterile aqueous suspension, is indicated as follows. Allergic States:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases:Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders:Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases:To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders:Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous:Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases:For palliative management of leukemias and lymphomas. Nervous System:Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases:Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases:To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases:Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders:As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Methylprednisolone Acetate Injectable Suspension, USP is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in strength: 40 mg per mL. Each mL of these preparations contains. Methylprednisolone acetate……………………………………40 mg. Polyethylene glycol 3350……………………………………29.1 mg. Polysorbate 80.………………………………………………1.94 mg. Monobasic sodium phosphate…………………………………6.8 mg. Dibasic sodium phosphate, USP……………………………..1.42 mg. Benzyl alcohol added as a preservative………………………9.16 mg. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below. Methylprednisolone Acetate Injectable Suspension, USP, sterile aqueous suspension, contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-170-05</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (62559-170-05) </PackageDescription>
    <NDC11Code>62559-0170-05</NDC11Code>
    <ProductNDC>62559-170</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180709</StartMarketingDate>
    <EndMarketingDate>20220731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205509</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180709</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62559-171-05</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (62559-171-05) </PackageDescription>
    <NDC11Code>62559-0171-05</NDC11Code>
    <ProductNDC>62559-171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180709</StartMarketingDate>
    <EndMarketingDate>20220731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205509</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180709</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62559-196-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-196-05) </PackageDescription>
    <NDC11Code>62559-0196-05</NDC11Code>
    <ProductNDC>62559-196</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077396</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)1,3- dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:. C15H10Cl2N2O2                              M.W. 321.16. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-197-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-197-05) </PackageDescription>
    <NDC11Code>62559-0197-05</NDC11Code>
    <ProductNDC>62559-197</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077396</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)1,3- dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:. C15H10Cl2N2O2                              M.W. 321.16. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-220-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (62559-220-05) </PackageDescription>
    <NDC11Code>62559-0220-05</NDC11Code>
    <ProductNDC>62559-220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxcarbazepine</ProprietaryName>
    <NonProprietaryName>Oxcarbazepine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078005</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXCARBAZEPINE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxcarbazepine Tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
    <Description>Oxcarbazepine Tablets USP are an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Oxcarbazepine Tablets USP meet USP Organic Impurities Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-221-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (62559-221-05) </PackageDescription>
    <NDC11Code>62559-0221-05</NDC11Code>
    <ProductNDC>62559-221</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxcarbazepine</ProprietaryName>
    <NonProprietaryName>Oxcarbazepine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078005</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXCARBAZEPINE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxcarbazepine Tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
    <Description>Oxcarbazepine Tablets USP are an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Oxcarbazepine Tablets USP meet USP Organic Impurities Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-222-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (62559-222-05) </PackageDescription>
    <NDC11Code>62559-0222-05</NDC11Code>
    <ProductNDC>62559-222</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxcarbazepine</ProprietaryName>
    <NonProprietaryName>Oxcarbazepine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078005</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXCARBAZEPINE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxcarbazepine Tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
    <Description>Oxcarbazepine Tablets USP are an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Oxcarbazepine Tablets USP meet USP Organic Impurities Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62559-277-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-277-05) </PackageDescription>
    <NDC11Code>62559-0277-05</NDC11Code>
    <ProductNDC>62559-277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nebivolol</ProprietaryName>
    <NonProprietaryName>Nebivolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203659</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nebivolol Tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>The chemical name for the active ingredient in nebivolol tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
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    <NDCCode>62559-278-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-278-05) </PackageDescription>
    <NDC11Code>62559-0278-05</NDC11Code>
    <ProductNDC>62559-278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <StartMarketingDate>20210917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203659</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nebivolol Tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>The chemical name for the active ingredient in nebivolol tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
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  <NDC>
    <NDCCode>62559-524-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-524-05) </PackageDescription>
    <NDC11Code>62559-0524-05</NDC11Code>
    <ProductNDC>62559-524</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260727</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076333</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril Hydrochloride Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
    <Description>Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (&gt; 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3‑phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril Hydrochloride Tablets USP contain 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride USP for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, hypromellose, lactose, microcrystalline cellulose, polydextrose, polyethylene glycol, talc, titanium dioxide and triacetin. In addition, the 5 mg, 10 mg and 20 mg contain yellow iron oxide, and the 20 mg and 40 mg contain red iron oxide.</Description>
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  <NDC>
    <NDCCode>62559-525-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-525-05) </PackageDescription>
    <NDC11Code>62559-0525-05</NDC11Code>
    <ProductNDC>62559-525</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260727</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076333</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril Hydrochloride Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
    <Description>Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (&gt; 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3‑phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril Hydrochloride Tablets USP contain 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride USP for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, hypromellose, lactose, microcrystalline cellulose, polydextrose, polyethylene glycol, talc, titanium dioxide and triacetin. In addition, the 5 mg, 10 mg and 20 mg contain yellow iron oxide, and the 20 mg and 40 mg contain red iron oxide.</Description>
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  <NDC>
    <NDCCode>62559-526-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-526-05) </PackageDescription>
    <NDC11Code>62559-0526-05</NDC11Code>
    <ProductNDC>62559-526</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
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    <StartMarketingDate>20260727</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076333</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril Hydrochloride Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
    <Description>Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (&gt; 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3‑phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril Hydrochloride Tablets USP contain 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride USP for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, hypromellose, lactose, microcrystalline cellulose, polydextrose, polyethylene glycol, talc, titanium dioxide and triacetin. In addition, the 5 mg, 10 mg and 20 mg contain yellow iron oxide, and the 20 mg and 40 mg contain red iron oxide.</Description>
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  <NDC>
    <NDCCode>62559-527-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (62559-527-05) </PackageDescription>
    <NDC11Code>62559-0527-05</NDC11Code>
    <ProductNDC>62559-527</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
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    <StartMarketingDate>20260727</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076333</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260727</StartMarketingDatePackage>
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    <IndicationAndUsage>Benazepril Hydrochloride Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
    <Description>Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (&gt; 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3‑phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril Hydrochloride Tablets USP contain 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride USP for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, hypromellose, lactose, microcrystalline cellulose, polydextrose, polyethylene glycol, talc, titanium dioxide and triacetin. In addition, the 5 mg, 10 mg and 20 mg contain yellow iron oxide, and the 20 mg and 40 mg contain red iron oxide.</Description>
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  <NDC>
    <NDCCode>62559-690-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62559-690-05) </PackageDescription>
    <NDC11Code>62559-0690-05</NDC11Code>
    <ProductNDC>62559-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211893</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62559-970-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (62559-970-01) </PackageDescription>
    <NDC11Code>62559-0970-01</NDC11Code>
    <ProductNDC>62559-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Penicillamine</ProprietaryName>
    <NonProprietaryName>Penicillamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210701</StartMarketingDate>
    <EndMarketingDate>20250930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209921</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PENICILLAMINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210701</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Penicillamine capsules are indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that penicillamine capsules are not of value in ankylosing spondylitis. Wilson’s Disease - Wilson’s disease (hepatolenticular degeneration) occurs in individuals who have inherited an autosomal recessive defect that leads to an accumulation of copper far in excess of metabolic requirements. The excess copper is deposited in several organs and tissues, and eventually produces pathological effects primarily in the liver, where damage progresses to postnecrotic cirrhosis, and in the brain, where degeneration is widespread. Copper is also deposited as characteristic, asymptomatic, golden-brown Kayser-Fleischer rings in the corneas of all patients with cerebral symptomatology and some patients who are either asymptomatic or manifest only hepatic symptomatology. Two types of patients require treatment for Wilson’s disease: (1) the symptomatic, and (2) the asymptomatic in whom it can be assumed the disease will develop in the future if the patient is not treated. The diagnosis, if suspected on the basis of family or individual history or physical examination, can be confirmed if the plasma copper-protein ceruloplasmin* is &lt;20 mg/dL and either a quantitative determination in a liver biopsy specimen shows an abnormally high concentration of copper (&gt;250 mcg/g dry weight) or Kayser-Fleischer rings are present. Treatment has two objectives:     1) to minimize dietary intake of copper;     2) to promote excretion and complex formation (i.e., detoxification) of excess tissue copper. The first objective is attained by a daily diet that contains no more than one or two milligrams of copper. Such a diet should exclude, most importantly, chocolate, nuts, shellfish, mushrooms, liver, molasses, broccoli, and cereals and dietary supplements enriched with copper, and be composed to as great an extent as possible of foods with a low copper content. Distilled or demineralized water should be used if the patient’s drinking water contains more than 0.1 mg of copper per liter. For the second objective, a copper chelating agent is used. In symptomatic patients this treatment usually produces marked neurologic improvement, fading of Kayser-Fleischer rings, and gradual amelioration of hepatic dysfunction and psychic disturbances. Clinical experience to date suggests that life is prolonged with the above regimen. Noticeable improvement may not occur for one to three months. Occasionally, neurologic symptoms become worse during initiation of therapy with penicillamine capsules. Despite this, the drug should not be withdrawn. Temporary interruption carries an increased risk of developing a sensitivity reaction upon resumption of therapy, although it may result in clinical improvement of neurological symptoms (see WARNINGS). If the neurological symptoms and signs continue to worsen for a month after the initiation of penicillamine capsule therapy, several short courses of treatment with 2,3-dimercaprol (BAL) while continuing penicillamine capsules may be considered. Treatment of asymptomatic patients has been carried out for over thirty years. Symptoms and signs of the disease appear to be prevented indefinitely if daily treatment with penicillamine capsules are continued. * For quantitative test for serum ceruloplasmin see: Morell, A.G.; Windsor, J.; Sternlieb, I.; Scheinberg, I.H.: Measurement of the concentration of ceruloplasmin in serum by determination of its oxidase activity, in “Laboratory Diagnosis of Liver Disease”, F.W. Sunderman; F.W. Sunderman, Jr., (eds.), St. Louis, Warren H. Green, Inc., 1968, pp. 193-195. Cystinuria - Cystinuria is characterized by excessive urinary excretion of the dibasic amino acids, arginine, lysine, ornithine, and cysteine, and the mixed disulfide of cysteine and homocysteine. The metabolic defect that leads to cystinuria is inherited as an autosomal, recessive trait. Metabolism of the affected amino acids is influenced by at least two abnormal factors: (1) defective gastrointestinal absorption and (2) renal tubular dysfunction. Arginine, lysine, ornithine, and cysteine are soluble substances, readily excreted. There is no apparent pathology connected with their excretion in excessive quantities. Cystine, however, is so slightly soluble at the usual range of urinary pH that it is not excreted readily, and so crystallizes and forms stones in the urinary tract. Stone formation is the only known pathology in cystinuria. Normal daily output of cystine is 40 to 80 mg. In cystinuria, output is greatly increased and may exceed 1 g/day. At 500 to 600 mg/day, stone formation is almost certain. When it is more than 300 mg/day, treatment is indicated. Conventional treatment is directed at keeping urinary cystine diluted enough to prevent stone formation, keeping the urine alkaline enough to dissolve as much cystine as possible, and minimizing cystine production by a diet low in methionine (the major dietary precursor of cystine). Patients must drink enough fluid to keep urine specific gravity below 1.010, take enough alkali to keep urinary pH at 7.5 to 8, and maintain a diet low in methionine. This diet is not recommended in growing children and probably is contraindicated in pregnancy because of its low protein content (see PRECAUTIONS). When these measures are inadequate to control recurrent stone formation, penicillamine capsules may be used as additional therapy, and when patients refuse to adhere to conventional treatment, penicillamine capsules may be a useful substitute. It is capable of keeping cystine excretion to near normal values, thereby hindering stone formation and the serious consequences of pyelonephritis and impaired renal function that develop in some patients. Bartter and colleagues depict the process by which penicillamine interacts with cystine to form penicillamine-cysteine mixed disulfide as. In this process, it is assumed that the deprotonated form of penicillamine, PS', is the active factor in bringing about the disulfide interchange. Rheumatoid Arthritis - Because penicillamine can cause severe adverse reactions, its use in rheumatoid arthritis should be restricted to patients who have severe, active disease and who have failed to respond to an adequate trial of conventional therapy. Even then, benefit-to-risk ratio should be carefully considered. Other measures, such as rest, physiotherapy, salicylates, and corticosteroids should be used, when indicated, in conjunction with penicillamine capsules (see PRECAUTIONS).</IndicationAndUsage>
    <Description>Penicillamine is a chelating agent used in the treatment of Wilson's disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS). It is 3-mercapto-D-valine. It is a white or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured:           [α]   25°   = -62.5° ± 2° (c = 1, 1N NaOH),                   Dcalculated on a dried basis. The empirical formula is C5H11NO2S, giving it a molecular weight of 149.21. The structural formula is. It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. Penicillamine Capsules USP for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: magnesium stearate and povidone. The capsule shells contain D&amp;C Yellow No. 10, titanium dioxide, gelatin, shellac, propylene glycol, potassium hydroxide and black iron oxide.</Description>
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